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Revance to Present New Clinical Data on DaxibotulinumtoxinA for Injection from the ASPEN Phase 3 Program at the 2022 American Academy of Neurology…

Posted on April 1, 2022 by Danzig

NASHVILLE, Tenn.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced they will give one oral presentation and present one poster at the 2022 American Academy of Neurology Annual Meeting, taking place on April 2-7, 2022 in Seattle, Washington.

We look forward to participating at AAN this year, where we will give our first, in-person oral presentation of the ASPEN-1 Phase 3 clinical trial results, and also present new data from the ASPEN-OLS Phase 3 open-label, long-term safety study of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, said Mark J. Foley, Chief Executive Officer of Revance. As we seek to help patients with this debilitating condition achieve long-lasting symptom relief, the important data from our ASPEN-1 Phase 3 program continues to show DaxibotulinumtoxinA for Injections long duration of effect and encouraging safety profile. The pivotal ASPEN-1 trial demonstrated two efficacious and well-tolerated dose levels of DaxibotulinumtoxinA for Injection compared to placebo, with consistent patient and clinician reports of improvement and treatment satisfaction. Results from the ASPEN-OLS study reinforce the long-term safety and efficacy of our pivotal study with up to four repeat doses.

Oral Presentation:

Poster:

The above abstracts are available online via the AAN website at http://www.aan.com.

About Revance

Revance is a commercial stage biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation, long-acting neuromodulator product, DaxibotulinumtoxinA for Injection. Revance has successfully completed Phase 3 clinical programs for DaxibotulinumtoxinA for Injection in glabellar (frown) lines, for which the company is currently pursuing U.S. regulatory approval, and in cervical dystonia. Revance is also evaluating DaxibotulinumtoxinA for Injection in adult upper limb spasticity. Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the OPUL Relational Commerce Platform. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX, which if approved, would be the first and only generic biosimilar to Botox and Botox Cosmetic. For more information or to join our team visit us at http://www.revance.com.

Revance Therapeutics and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

Resilient Hyaluronic Acid and RHA are trademarks of TEOXANE SA.

BOTOX is a registered trademark of Allergan, Inc.

Forward-Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, efficacy and duration of DaxibotulinumtoxinA for Injection and our development of a biosimilar to BOTOX with our partner, Viatris, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals; our ability to remediate deficiencies identified by the FDA and obtain FDA approval of the BLA for DaxibotulinumtoxinA for Injection for glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, future revenues, capital requirements, our financial performance and the economics of DaxibotulinumtoxinA for Injection, the RHA Collection of dermal fillers and OPUL; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for our product candidates and to acquire supplies of the RHA Collection of dermal fillers; the uncertain clinical development process, the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of the RHA Collection of dermal fillers, OPUL and our drug product candidates, if approved; our ability to continue to successfully commercialize the RHA Collection of dermal fillers and OPUL and our ability to successfully commercialize DaxibotulinumtoxinA for Injection, if approved, and the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of Hint, Inc; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; the volatility of our stock price; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" in our Form 10-K, filed with the SEC on February 28, 2022. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

Horizon Therapeutics Highlights Presentation During Poster Presentation At American Academy Of Neurology On Co.’s UPLIZNA – Benzinga

Posted on April 1, 2022 by Danzig

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Sigyn Therapeutics Appoints Ajay Verma, MD, Ph.D. to its Scientific Advisory Board – GlobeNewswire

Posted on April 1, 2022 by Danzig

SAN DIEGO, CA, March 31, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (OTC Markets:SIGY), a medical technology company focused on the treatment of pathogen-associated conditions that induce sepsis and other life-threatening disorders, today announced the appointment of Ajay Verma, M.D., Ph.D.to its Scientific Advisory Board.

Dr. Verma is a recognized thought leader in the field of neurology. His extensive clinical experience and resulting insights are anticipated to contribute to the continued advancement of Sigyn Therapy. Sigyn Therapy is an extracorporeal blood purification technology being advanced to treat life-threatening inflammatory disorders.

Dr. Verma is a neurologist, neuroscientist, drug developer, inventor, and biotech science advisor. Dr. Verma most recently headed R&D efforts at Yumanity Therapeutics, developing drugs against novel targets for treating neurodegenerative diseases. Prior to that he was the EVP of Research and Experimental Medicine at Codiak Biosciences. He has also served as CMO at United Neuroscience (now called Vaxxinity), VP of Neurology at Biogen and Novartis, and Director of Neuroscience Experimental Medicine at Merck. His drug development experience spans small molecule, peptide/protein, antibody, oligonucleotide, vaccine, and exosome drug platforms. He has largely focused on translational and early clinical development in neurology indications using precision drug development approaches that leverage biomarkers and experimental medicine paradigms. Prior to his Biopharma career, Dr. Verma was Professor of Neurology at the Uniformed Services University of the Health Sciences. He also worked as a staff neurologist at the Walter Reed Army Medical Center for 11 years after completing his neurology residency there. He received his M.D. and Ph.D. from Johns Hopkins University, where he trained in the laboratory of Dr. Solomon Snyder. He received his B.S. in Zoology from the University of Maryland.

About Sigyn Therapeutics

Sigyn Therapeutics is a medical technology company focused on the treatment of pathogen-associated conditions that precipitate sepsis, the leading cause of hospital deaths worldwide. Sigyn Therapy is a multi-function blood purification technology that extracts pathogen sources of life-threatening inflammation in concert with the broad-spectrum elimination of inflammatory mediators from the bloodstream.

Beyond establishing a novel strategy to combat sepsis, candidate treatment indications for Sigyn Therapy include, but are not limited to; emerging pandemic threats, hepatic encephalopathy, bridge to liver transplant, and community-acquired pneumonia (CAP), which is a leading cause of death among infectious diseases, the leading cause of death in children under five years of age, and a catalyst for approximately 50% of sepsis and septic shock cases.

To learn more, visit http://www.SigynTherapeutics.com

Cautionary Note Regarding Forward-Looking Statements

This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (Sigyn) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company's ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company's ability to manufacture Sigyn Therapy, the Company's ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Contacts:

Stephen Kilmer

Sigyn Therapeutics, Inc.

Investor Relations

(646) 274-3580

stephen@sigyntherapeutics.com

Media Contacts:

Russo Partners, LLC

David Schull

(212) 845-4271

David.Schull@russopartnersllc.com

Nic Johnson

(212) 845-4242

Nic.Johnson@russopartnersllc.com

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Sigyn Therapeutics Appoints Ajay Verma, MD, Ph.D. to its Scientific Advisory Board - GlobeNewswire

Global In-Vitro Diagnostics For Cardiology And Neurology Market Driving Factors, Industry Growth, And Forecast To 2031 ChattTenn Sports – ChattTenn…

Posted on April 1, 2022 by Danzig

Research Nester published a report titled In-Vitro Diagnostics for Cardiology and Neurology Market: Global Demand Analysis & Opportunity Outlook 2031 which delivers detailed overview of the global in-vitro diagnostics for cardiology and neurology market in terms of market segmentation by product type, technology, end user, and by region.

Further, for the in-depth analysis, the report encompasses the industry growth indicators, restraints, supply and demand risk, along with detailed discussion on current and future market trends that are associated with the growth of the market.

Theglobal in-vitro diagnostics for cardiology and neurology marketis estimated to occupy a sizeable revenue by growing at a CAGR of ~6% during the forecast period, i.e., 2022 2031, ascribing to the rising adoption of point-of-care testing devices to boost the demand for in-vitro diagnostics tests. Along with this, growing prevalence of chronic disorders across the globe, and escalating awareness levels associated with disease diagnosis, and rapidly increasing geriatric population are also expected to accelerate the growth of the market in the upcoming years.

The market is segmented by product type, technology and end user. Based on type, the reagents & consumables segment is anticipated to acquire the largest share during the forecast period on the back of the high precision and accurate diagnosis provided by recently developed reagents & consumables. Additionally, by end user, the hospitals segment is projected to grab the largest share over the forecast period attributing to the tremendous amount of diagnostic testing required to support a clinical decision for enhancing patient discovery, which is only possible in a hospital facility.

For More Information About This Report Visit:https://www.researchnester.com/sample-request-3849

Geographically, the global in-vitro diagnostics for cardiology and neurology market is segmented into five major regions, namely North America, Europe, Latin America, Asia Pacific, and the Middle East & Africa. Asia Pacific is evaluated to witness noteworthy growth in the market during the forecast period. This can be attributed to the rising investments by healthcare providers for improving the diagnostics infrastructure in the region. Moreover, the market in North America is assessed to acquire the largest share over the forecast period ascribing to the high healthcare spending, and strong presence of market players in the region.

The research is global in nature and covers detailed analysis on the market in North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC [Finland, Sweden, Norway, Denmark], Poland, Turkey, Russia, Rest of Europe), Latin America (Brazil, Mexico, Argentina, Rest of Latin America), Asia-Pacific (China, India, Japan, South Korea, Indonesia, Singapore, Malaysia, Australia, New Zealand, Rest of Asia-Pacific), Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of Middle East and Africa). In addition, analysis comprising market size, Y-O-Y growth & opportunity analysis, market players competitive study, investment opportunities, demand for future outlook etc. has also been covered and displayed in the research report.

Growing Occurrence of Chronic Disorders Around the World to Bolster Market Growth

Since the last few years, the prevalence of several cardiovascular and neurological diseases is increasing significantly. This is resulting in the rise in awareness regarding early diagnosis among the population and an increase in routine diagnosis, which in turn is anticipated to boost the demand for advanced in-vitro diagnostics products in the near future.

However, the expensiveness of in-vitro diagnostics instruments is expected to operate as key restraint to the growth of the global in-vitro diagnostics for cardiology and neurology market over the forecast period.

This report also provides the existing competitive scenario of some of the key players of the global in-vitro diagnostics for cardiology and neurology market which includes company profiling of Thermo Fisher Scientific Inc., F. Hoffman-La Roche Ltd, Sysmex Corporation, Siemens AG, Becton, Dickinson, and Company, DiaSorin S.p.A., Quest Diagnostics, Inc., Bio-Rad Laboratories, Inc., Abbott Laboratories, Danaher Corporation, and others. The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials and recent news and developments. On the whole, the report depicts detailed overview of the global in-vitro diagnostics for cardiology and neurology market that will help industry consultants, equipment manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market centric strategies according to the ongoing and expected trends in the future.

Get a Sample Copy Of This Report With Graphs and Charts:https://www.researchnester.com/sample-request-3849

Research Nester is a one-stop service provider, leading in strategic market research and consulting with an unbiased and unparalleled approach towards helping global industrial players, conglomerates and executives to make wise decisions for their future investment and expansion by providing them qualitative market insights and strategies while avoiding future uncertainties. We believe in honesty and sheer hard work that we trust is reflected in our work ethics. Our vision is not just limited to gain the trust of our clients but also to be equally respected by our employees and being appreciated by the competitors.

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Research NesterEmail: [emailprotected]Tel: +1-6465869123

Wellness Wednesday: neurologist concerned about Multiple Sclerosis trend hes seen throughout the pandemic – WSYR

Posted on January 29, 2022 by Danzig

SYRACUSE, N.Y. (WSYR-TV) Central New York has the highest population of patients with Multiple Sclerosis (MS) in the nation. Doctors have been speculating why for years, and it may be getting worse.

A neurologist at St. Josephs Health is concerned about the trend hes seen throughout the pandemic.

Dr. Fahed Saada recently treated a 24-year-old man. His brain and spine were riddled with lesions. Hes in the early stages of MS and joins a growing list of Saadas patients, adding to a trend no neurologist wants to see.

Ive never seen so many acute Multiple Sclerosis cases over the years compared to this past year and I dont know why.

Saada says other viruses can increase our risk, but it will be years before we learn COVID-19s contributions, if any. In the meantime, more people are getting sick.

Early treatment can give patients some improvement, but over time, MS progresses.

The disease disrupts the brains ability to send messages to the rest of the body. Theres no cure, and eventually, it causes permanent damage to the nerves.

These lesions, if theyre not treated appropriately and quickly, they become what we call black holes in the brain.

Its hard to stop an uptick in cases when doctors dont know whats causing it.

However, neurologists do know that places north of the equator are at a higher risk because patients with MS have low vitamin D levels.

Doctors also know we here in Central New York dont get a lot of sunlight in the winter.

For now, though, Saada says its a medical mystery doctors desperately want to solve.

Saada says a vitamin D supplement may help boost your prevention, but you should always talk to your doctor before making any changes to your medication and supplements.

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Wellness Wednesday: neurologist concerned about Multiple Sclerosis trend hes seen throughout the pandemic - WSYR

8 Things Neurologists Do When They Have A Headache – HuffPost

Posted on January 29, 2022 by Danzig

Whether stress-induced or genetic, headaches are a common condition that can affect anyone. This includes neurologists AKA the specialists who treat headache disorders.

Headache is any pain affecting the head, upper face or upper neck. Headaches are called primary when they arise from biological changes within the brain itself, Robert Kaniecki, the director of the UPMC Headache Center in Pittsburgh, told HuffPost. These include migraine headaches, tension-type headaches, and cluster headaches.

Migraine-induced headaches cause additional symptoms such as nausea, sensitivity to light and noise, fatigue, visual disturbances and more. People may also experience secondary headaches if there is another underlying illness or cause for the headache, Kaniecki said.

Worldwide, headache disorders are considered one of the most common yet under-treated disorders of the nervous system. Additionally, a 2018 study found that one in six people in the U.S. reported having a migraine or severe headache over a three-month period.

HuffPost spoke to neurologists about the things they personally do when experiencing a headache, and why these go-to strategies work.

Find a calming space.

Creating a quiet and relaxing environment is often the first step some neurologists take to alleviate headache pain.

If I have a headache, I rest or lie down for as long as I can, and it doesnt depend on the time of day, said Faye Begeti, a neurology doctor and neuroscientist in the U.K. With migraines in particular, people usually find that they have to lie down in a quiet, dark room.

Distract your mind.

With busy schedules and responsibilities, taking a quick siesta isnt always feasible. Rami Burstein, a professor of anesthesia and neuroscience at Harvard Medical School, explained that he tends to utilize relaxing distractions when he cant power nap in the workplace.

As contrary as it may sound, walking can be helpful and reading, Burstein said.

Figure out your triggers.

Understanding your headache triggers can serve as both a preventative and in-the-moment approach to address pain.

Most of my migraine attacks are visually triggered or are triggered when I am ambivalent or worried about a decision or situation. The latter is a bit harder to control, but its fascinating to recognize, said Jan Lewis Brandes, the director and founder of the Nashville Neuroscience Group. Red wine can be a trigger for me, so I am careful about not having more than a few ounces.

Additionally, a common headache trigger is sleep disturbances. Theres a misconception that headaches are primarily caused by sleep deprivation, but Begeti explained that sticking to a consistent sleep schedule may be more important than the amount of sleep you get every night.

This is something that I didnt know when I was at university, so I would reliably have a headache every single Saturday after staying up late the day before, and sleeping in on the weekend, Begeti said.

Westend61 via Getty Images

Get hydrated ASAP.

Many neurologists pay closer attention to what they drink when experiencing headache pain. As simple as it sounds, water is your best friend when you have a headache or migraine.

Kristina Lopez, an assistant professor at the West Virginia University Rockefeller Neuroscience Institute and headache specialist, said that her headaches are typically a signifier that she needs to up her hydration. While Lopez explained that researchers arent quite sure why drinking water eases headache pain (there are a number of theories), its a cheap and safe preventative and as-needed treatment strategy.

I finally took my own advice and started getting a consistent eight hours of sleep and drinking more water, Lopez said. Its wild how much better I feel.

Try drinking a little coffee, too.

Though it may seem counterintuitive, caffeine can actually be a remedy for headaches. Brandes said that drinking a cup of coffee is the first step she takes when combatting a migraine attack, followed by drinking a glass of water and taking medication.

Caffeine causes blood vessels to narrow and restricts blood flow around the brain, which can relieve pain. However, moderation is key: Consuming caffeine on the regular may have the opposite effect, leading to withdrawal headaches if you suddenly stop drinking your morning espresso or green tea.

Eat smaller meals throughout the day.

Interestingly, another personal tip from Kanieki is to break snacks and meals into five to six portions throughout the day.

This is because low blood sugar may exacerbate headache pain, along with migraine symptoms. Try swapping up your meal times or breaking down bigger meals into smaller parts that you eat intermittently and see if it helps.

Take pain relievers when necessary.

Depending on the severity of her headache, Begeti will take over-the-counter pain medication such as non-steroidal anti-inflammatory drugs (aka NSAIDs) or acetaminophen. However, be sure to keep track of the amount of pain relievers you take: Begeti noted that she limits her monthly intake of over-the-counter pain medication to under 10 days a month to avoid medication-overuse headaches.

If you are experiencing more severe pain or symptoms, it may be worth a trip to the neurologist to see if you could benefit from prescription medication.

I get migraine attacks and will take a triptan an as-needed migraine pain medication and a nausea medication when I feel an episode coming on, Lopez said.

Remember that some factors are outside of your control.

While some things can help you prevent headache pain, its important to note that not every headache can be linked to lifestyle or environmental factors.

Sometimes there are no notable triggers to headaches, Begeti said. A big part of why people get headaches is due to genetics, and I see headaches that run in families.

Headache pain can range from mild to debilitating. Trying neurologist-approved strategies until you find what specifically works for you may help to alleviate your pain in the long run. Establishing a unique, at-home routine is vital to treating these conditions effectively.

Its important to listen to your body. I find that a headache may resolve if I do that and it certainly prevents it from getting worse, Begeti said.

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8 Things Neurologists Do When They Have A Headache - HuffPost

Characteristics of peer-based interventions for individuals with neurological conditions: a scoping review – DocWire News

Posted on January 29, 2022 by Danzig

This article was originally published here

Disabil Rehabil. 2022 Jan 27:1-32. doi: 10.1080/09638288.2022.2028911. Online ahead of print.

ABSTRACT

PURPOSE: Peer-based interventions are increasingly popular and cost-effective therapeutic opportunities to support others experiencing similar life circumstances. However, little is known about the similarities and differences among peer-based interventions and their outcomes for people with neurological conditions. This scoping review aims to describe and compare the characteristics of existing peer-based interventions for adults with common neurological conditions.

MATERIALS AND METHODS: We searched MEDLINE, CINAHL, PsychInfo, and Embase for research on peer-based interventions for individuals with brain injury, Parkinsons, multiple sclerosis, spinal cord injury, and stroke up to June 2019. The search was updated in March 2021. Fifty-three of 2472 articles found were included.

RESULTS: Characteristics of peer-based intervention for this population vary significantly. They include individual and group-based formats delivered in-person, by telephone, or online. Content varied from structured education to tailored approaches. Participant outcomes included improved health, confidence, and self-management skills; however, these varied based on the intervention model.

CONCLUSION: Various peer-based interventions exist, each with its own definition of what it means to be a peer. Research using rigorous methodology is needed to determine the most effective interventions. Clear definitions of each program component are needed to better understand the outcomes and mechanism of action within each intervention.IMPLICATIONS FOR REHABILITATIONRehabilitation services can draw on various peer support interventions to add experiential knowledge and support based on shared experience to enhance outcomes.Fulfilling the role of peer mentor may be beneficial and could be encouraged as part of the rehabilitation process for people with SCI, TBI, Stroke, PD, or MS.In planning peer-based interventions for TBI, Stroke, SCI, PD, and MS populations, it is important to clearly define intervention components and evaluate outcomes to measure the impact of the intervention.

PMID:35085058 | DOI:10.1080/09638288.2022.2028911

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Characteristics of peer-based interventions for individuals with neurological conditions: a scoping review - DocWire News

Diagnosis and management of functional neurological disorder – The BMJ

Posted on January 29, 2022 by Danzig

Our search found 37 bedside clinical tests or groups of tests for motor FND (functional weakness and functional movement disorder) that had some formal validation (table 2). Sample size varied between 8 and 107 patients with FND. Most investigations of positive signs were conducted in a single study or a small number of studies (maximum five for the Hoover sign), allowing for the calculation of pooled specificity and sensitivity by merging data from different studies. Five studies reported on the inter-rater reliability of positive signs.

Overall, the specificities of validated signs are high, ranging from 64% to 100%; however, the sensitivities are lower, ranging from 9% to 100%. Inter-rater reliability of these signs is overall good to excellent (defined as values: <0.2 poor/0.21-0.4 fair/0.41-0.6 moderate/0.61-0.8 good/>0.8 excellent).

General signs common to all FND presentations are: variability of the symptom, which can be observed during history taking and examination, and effortful or grimacing expression while following the examiners instructions during examination. If suspecting a functional movement disorder, test oculomotor function to show abnormal eye movements and in particular convergence spasm,100 even if the patient did not endorse this as a concern during history taking.

When assessing gait, look for typical positive signs such as monoplegic leg dragging, excessive visible effort (huffing and puffing sign),50 falling toward support (chair nearby, table, wall), excessive slowness, hesitation or caution, non-economic posture (for example knee flexed), and knee buckling (sudden loss of tone at each step).101 Asking a patient with severe gait disorder to propel a chair while sitting on it will show improvement in FND.51

When assessing hemifacial spasm, look for typical signs such as long contraction of more than three seconds, lip pulling (tonic deviation of the lip, often the lower one) sometimes with platysma contraction, and lack of other Babinski sign for hemifacial spasm (other Babinski sign=eyebrow elevation on the side of the spasm).102 Positive signs for functional orofacial movements in comparison with tardive dyskinesia are: lack of chewing movements, lack of self-biting, lingual movements without mouth movements, and abnormal speech.45 A large case series (61 patients) that focused on facial functional movement103 reported involvement of the lip as the most frequent (60.7%, with the lip pulling feature).

When assessing movements of the trunk, look for the typical positive sign of asymmetry in strength of the sterno-cleido-mastoid muscle.53 A functional Romberg sign is described as large movements of imbalance with sudden steps and no falls and improvement with cognitive distraction or numbers drawn on the back.48

When assessing episodes of cataplexy (brief, symmetrical loss of muscle tone with retained consciousness precipitated by strong emotions) look for positive signs54 such as lack of sudden facial expression change, facial jerks or grimaces, postural dyscontrol (head drop, trunk fall), in addition to preserved tendon reflexes (which typically disappear during cataplexy associated with narcolepsy).

When assessing upper arm weakness, look for discordance or inconsistency in strength (at different instances during the examination), as well as a give-way/collapsing pattern, drift without pronation, and/or co-contractions of agonist and antagonist muscles preventing movement of the tested joint. As a cautionary note, give-way/collapsing pattern of weakness is common in patients with pain limited weakness (and pain limited weakness should not be mistaken for functional limb weakness).104 In cases of complete hand plegia, involuntary abduction of the fifth finger can be seen when the patient is asked to do a forced abduction against the examiners resistance on the healthy hand.58 The flex-ext sign, which is the equivalent of the Hoover sign,105 can be elicited as follows: the involuntary flexion of the arm at the elbow that occurs when the patient focuses on extending the healthy elbow against the examiners resistance is better than the voluntary flexion.59

When assessing lower limb weakness, also look for discordance/inconsistence, give-way/collapsing weakness, co-contractions, and the Hoover sign.61 The classical way to describe a positive Hoover sign is when the involuntary hip extension (when the patient focuses on flexing the healthy leg against the examiners resistance) is stronger than the voluntary hip extension. A similar pattern can be found during leg abduction60: when the patient is asked to do a forced abduction with both legs against the examiners resistance, the weak leg will have a stronger involuntary abduction than when the voluntary abduction is tested. In patients with severe unilateral leg weakness, positioning passively the leg in flexion with the soles on the bed (spinal injury test)62 shows a discordance in strength as the weak leg will not fall on the side, as expected in complete weakness.

When assessing tremor, typical signs are distractibility, entrainment, and increase in amplitude with weight load on the wrists. In addition, look for variability in amplitude, frequency, and direction of tremor.63 A whack a mole sign can be seen106: when the limb affected by tremor is immobilized by the examiner, the tremor appears in another body segment (head, trunk, other arm, or legs).

No validated clinical signs are available for assessing dystonia, but a pattern of adult sudden onset fixed dystonia (typically clenched fist sparing thumb and index finger107) or equinovarus foot is suggestive of functional dystonia.108 Associated prominent pain and other FND signs can help support the diagnosis.109

When assessing tics, no validated signs are available but clinical clues can help identify functional tics110111: lack of premonitory urge and inability to suppress the movement, female preponderance, additional FND symptoms, lack of response to anti-tic medication, and absence of family history. In functional tics, the cranial region is less affected, the type of tic is often blocking (ie, interferes with voluntary action) and pali, echo, and copro phenomenon are less common.

Overall, the evidence for rule-in motor signs shows very high specificity, which advocates for their routine use in clinical practice. A range of educational pictorial and video libraries illustrate many of these signs.2101102112113 Too much emphasis on a single sign, however, can lead to false positives. In a cohort of 190 patients diagnosed with a neurological disorder, 37 (20%) had at least one positive functional neurological sign.91 Interestingly, regression analysis showed that this 20% of the cohort had typical risk factors known in patients with FND, suggesting that the presence of positive signs in this subgroup could either be false positives or indicate the presence of an FND comorbidity. Keep in mind the possibility that the patient has both FND and another neurological disorder: recent reports describe functional neurological signs in a subset of patients with Parkinsons disease114115 or multiple sclerosis.116 Overall, data from a systematic review and a prospective study underscore that rates of misdiagnosis in FND since 1970 (once confirmed) are low, and between 1% and 4%.117118

Recently, efforts have been made to integrate additional clinical features in the process of diagnosis, such as, for example, abrupt onset, fluctuations of the motor symptom, comorbid pain, and fatigue.119 The presence of these features should raise the index of suspicion and prompt a more systematic search of signs positive for FND.

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Diagnosis and management of functional neurological disorder - The BMJ

Modeling published in Neurology and Therapy suggests that lecanemab could delay progression to Alzheimer’s dementia by several years – PR Newswire

Posted on April 27, 2022 by Danzig

STOCKHOLM, April 27, 2022 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that an article about long-term health outcomes of the investigational anti-amyloid-beta (A) protofibril antibody lecanemab (BAN2401) in people living with early Alzheimer's disease (AD), using disease modeling, was published in the peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of the disease.

The article focuses on the long-term clinical outcomes for people living with early AD (mild cognitive impairment (MCI) and mild AD) who have amyloid pathology, comparing lecanemab together with standard of care (SoC) versus SoC alone (acetylcholinesterase inhibitor or memantine). The simulation is based on patients being treated until they reach the moderate AD stage. The disease simulation model (AD ACE model1) is based on the results of the Phase 2b clinical trial evaluating the efficacy and safety of lecanemab, and from ADNI (Alzheimer's Disease Neuroimaging Initiative) study results.

Lecanemab treatment was estimated to slow the rate of disease progression, resulting in an extended duration of MCI due to AD and mild AD dementia and shortened the duration in moderate and severe AD dementia. In the model the mean time advancing to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.51 years, 3.13 and 2.34, respectively. The model also predicted a lower life-time probability of admission to institutional care with lecanemab treatment.

"The results from the simulation done by Eisai demonstrate the potential clinical value of lecanemab for patients with early AD and how it could slow the rate of disease progression, delay progression to AD dementia with several years and reduce the need for institutionalized care. Analyses such as these are important to understand the potential long-term effects for patient, families and society offered by lecanemab treatment beyond what can be seen in clinical trials. The outcome of the Clarity AD Phase 3 study will be essential to further refining this model, and we are looking forward to the topline results later this year," said Gunilla Osswald, BioArctic's CEO.

Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the second quarter 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial is expected by end of September 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

For further information, please contact:Gunilla Osswald, CEO E-mail: [emailprotected] Phone: +46 8 695 69 30

Oskar Bosson, VP Communications and IRE-mail: [emailprotected]Phone: +46 70 410 71 80

The information was released for public disclosure, through the agency of the contact persons above, on April 27, 2022, at 08:00 a.m. CET.

About lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to, neutralize and eliminate soluble toxic A aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture, and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Currently, lecanemab is being studied in a pivotal Phase 3 clinical study in symptomatic early AD (Clarity AD), following the outcome of the Phase 2b clinical study (Study 201). In addition, the Phase 3 clinical study, AHEAD 3-45, for individuals with preclinical (asymptomatic) AD, meaning they are clinically normal and have intermediate or elevated levels of brain amyloid, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium, funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai. In 2021, DIAN-TU selected lecanemab for a clinical trial for dominantly inherited Alzheimer's disease as a background anti-amyloid treatment when exploring combination therapies with anti tau treatments in dominantly inherited Alzheimer's disease subjects. In June 2021, FDA granted lecanemab Breakthrough Therapy designation and in September 2021, Eisai initiated a rolling submission for the US FDA Biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway. In December 2021, FDA granted lecanemab Fast track designation and the second part of the rolling application was submitted. Eisai expects the rolling submission to be completed during the second quarter 2022.

About the collaboration between BioArctic and EisaiSince 2005, BioArctic has long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed in December 2007, and the Development and Commercialization agreement for the antibody BAN2401 back-up for Alzheimer's disease, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory filings, approvals, and sales milestones as well as royalties on global sales.

About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. BioArctic's Class B share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information about BioArctic, please visit http://www.bioarctic.com.

1Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: Development and validation. Alzheimers Dement (NY). 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.001Tafazzoli and Kansal. Disease simulation in drug development, External validation confirms benefit in decision making. The Evidence Forum. 2018.https://www.evidera.com/wp-content/uploads/2018/10/07-Disease-Simulation-in-Drug-Development_Fall2018.pdf

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Modeling published in Neurology and Therapy suggests that lecanemab could delay progression to Alzheimer's dementia by several years - PR Newswire

Neurologists React to CMS’ Proposed NCD Decision on Anti-Amyloid Monoclonal Antibodies for Alzheimer’s Disease in the Latest from Spherix Global…

Posted on January 29, 2022 by Danzig

EXTON, Pa., Jan. 27, 2022 /PRNewswire/ -- On January 11th, the Centers for Medicare and Medicaid Services (CMS)' proposed Medicare reimbursement of FDA-approved anti-amyloid monoclonal antibodies (mAbs) be limited to clinical trials under Coverage with Evidence Development (CED). Days later, Spherix surveyed 75 U.S. neurologists and Alzheimer's disease specialists (including five follow-up interviews) to evaluate their awareness of and opinions on this unprecedented event.

The resulting insights are part of a two-wave Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies service. The second wave will be fielded immediately following the publication of the final determination.

Key takeaways from the first wave of research include:

Indeed, according to an interviewed neurologist, "To pre-judge before the data is submitted on the other three products is unfair. I don't think that that's reasonable because one of them may show a significant clinical improvement."

One neurologist noted, "If Lilly had very strong data on clinical benefit [with donanemab], not just clearing of amyloid, and on the side effect profile, I hope that CMS would change its decision for that particular drug."

Positive cognitive and functional data with acceptable safety from at least one of the ongoing Phase III programs with anti-amyloid mAbs would positively impact neurologists' currently low willingness to participate in such trials.

As mentioned by one interviewed neurologist, "The FDA is very concerning. As you probably are aware, the advisory committee, which were all neurologists and memory disorder neurologists, almost unanimously recommended against it [Aduhelm's approval] and then the FDA went around and said yes, so you lose a lot of confidence right now. My confidence in CMS is much better, much improved. I think they did the right thing. I think this is necessary. Too expensive and too potentially harmful to just willy-nilly start using these medications. We need to know definitively that these are really beneficial."

While CMS' draft NCD decision is specific to anti-amyloid mAbs, the Special Topix report also captures insights on the potential impact that the proposal could have on emerging therapies for Alzheimer's disease with alternative mechanisms of action (i.e., non-amyloid-targeted).

About Special Topix

Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies (US)includes two waves of research, collecting feedback from U.S. neurologists and Alzheimer's disease specialists about their awareness of and opinions on CMS' draft and final National Coverage Determination (NCD) decision on FDA-approved mAbs targeting amyloid for the treatment of Alzheimer's disease. The waves of research will field immediately following the releases of the draft and final NCD decisions.

Therapies covered include:

Learn more about our services here.

About Spherix Global Insights

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information, contact:

Virginia Schobel, Neurology Franchise Head

info@spherixglobalinsights.com

http://www.spherixglobalinsights.com

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Avadel Pharmaceuticals Announces Interim Data from the Open-Label RESTORE Study at the 2022 American Academy of Neurology Annual Meeting -…

Posted on April 27, 2022 by Danzig

DUBLIN, Ireland, April 25, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the presentation of interim data from the ongoing RESTORE open-label extension/switch study of FT218 at the 2022 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 24-26, 2022. FT218 is the Companys lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. The presentation highlights results from a questionnaire assessing patient preference for the once-nightly versus twice-nightly dosing regimen and another questionnaire assessing experiences with the second nightly dose in patients who switched from twice-nightly oxybates to FT218.

Twice-nightly oxybates for narcolepsy require a challenging dosing regimen that disrupts nighttime sleep. The results from the nocturnal adverse event questionnaire illustrate the burden that the second dose places on some patients, who already struggle with getting a full night of refreshing sleep, said Asim Roy, M.D., presenting author and Medical Director of the Ohio Sleep Medicine Institute. In my experience with patients in my practice, a once-at-bedtime option like FT218 would ease this burden and has the potential to be a major advance for the entire narcolepsy community.

At an interim data cutoff date of September 7, 2021, 35 participants who switched from twice-nightly oxybates to once-at-bedtime FT218 completed patient preference questionnaires three months after switching, with responses indicating that 94.3% (33/35 participants) preferred the once-nightly versus twice-nightly dosing regimen. As of the data cutoff, 60 participants who switched from twice-nightly oxybates to FT218 also completed a nocturnal adverse event questionnaire prior to switching to assess their experiences with the second nightly sodium oxybate dose. Results from the questionnaire follow:

These interim results from the ongoing RESTORE study highlight the preference for the once-at-bedtime versus twice-nightly dosing regimen among people who have switched from the twice-nightly formulation, said Douglas Williamson, M.D., Chief Medical Officer of Avadel. Further, they provide an insight into the challenges that patients face with a second, middle-of-the-night dose; challenges which may have been underappreciated due to the lack of other oxybate options. By eliminating the need for a second dose, FT218 has the potential to ease the burden facing sodium oxybate-eligible narcolepsy patients, if approved.

The abstract is available on the AAN website, and the virtual poster hall will be available to registrants until May 14, 2022.

About NarcolepsyNarcolepsy is a chronic neurological condition that impairs the brain's ability to regulate the sleep-wake cycle. The condition affects approximately one in 2,000 people in the United States with the cardinal symptom of EDS. Additional symptoms can vary by person and may include DNS, a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), sleep paralysis and hypnagogic and hypnopompic hallucinations.

About FT218FT218 is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of EDS or cataplexy in adults with narcolepsy.

In March 2020, Avadel completed the REST-ON trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in adults with narcolepsy. Among the three co-primary endpoints, FT218 demonstrated statistically significant and clinically meaningful results in EDS, the clinicians overall assessment of the patients functioning, and reduction in cataplexy attacks for all three evaluated doses compared to placebo.

In January 2018, the FDA granted FT218 Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for those with narcolepsy due to the consequences of middle-of-the-night dosing of the approved product. A marketing application for FT218 is currently under review by the FDA.

Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study. For more information, visit: http://www.restore-narcolepsy-study.com.

AboutAvadel Pharmaceuticals plcAvadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of EDS and cataplexy in adults with narcolepsy. For more information, please visit http://www.avadel.com.

Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, our expectations of the therapeutic benefits and tolerability of FT218, if approved; and patient preference and market acceptance of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as will, may, could, believe, expect, look forward, on track, guidance, anticipate, estimate, project, next steps and similar expressions, and the negatives thereof (if applicable).

Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the Risk Factors section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021, which we filed with the Securities and Exchange Commission on March 16, 2022, and subsequent SEC filings.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Investor Contact:Courtney TurianoStern Investor Relations, Inc. Courtney.Turiano@sternir.com (212) 698-8687

Media Contact:Nicole Raisch GoelzReal Chemistryngoelz@realchemistry.com(408) 568-4292

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Three out of ten consultations in primary care and neurology are referred for headaches – Euro Weekly News

Posted on April 27, 2022 by Danzig

Quirnsalud has a headache programme in all its centers in the province of Alicante in which this condition is addressed comprehensively.

Three out of ten consultations in primary care and neurology are prompted by headaches and migraines, according to the Spanish Society of Neurology. The high incidence, says Dr. Erika Torres, neurologist and specialist in headaches at Quirnsalud Torrevieja and Alicante, delays access to a specialized consultation and increases the risk of chronic pain and disability by not obtaining a diagnosis, treatment and adequate follow-up of the patient.

Poorly controlled headaches can become a major cause of functional limitation and disability, causing repercussions that reduce the quality of life in all areas of life for the patient: work, family, leisure, etc. For this reason, indicates the neurologist from Quirnsalud Torrevieja and Alicante, it is essential to carry out an adequate and early diagnosis of the type of headache suffered in order to carry out the correct treatment, personalizing it, taking into account the specific characteristics of each patient.

Differences between migraines and headaches

Headaches are divided into two groups: a first group that includes primary headaches, including sporadic or chronic migraines and tension headaches in which the pain is not related to any disease, and a second group that includes secondary headaches in which there is an underlying cause for the headache and is a symptom of another disease such as eye disorders or fever. Tension-type headache would be the most prevalent type of primary headache, affecting 66% of the population.

Migraines are expressed with different symptoms than tension headache. As Dr. Torres explains, While migraine presents as a pain on one side of the head with pulsating characteristics or very intense pressure that can be accompanied by nausea, vomiting and discomfort from sounds, light or smells, tension-type headache is located in the whole head, with less intense pain than migraine, but uncomfortable because it is more constant and is usually associated with a feeling of dizziness and dullness.

To avoid chronic headaches, Dr. Torres recommends healthy lifestyle habits, not abusing painkillers and going to a specialist to receive adequate treatment.

Quirnsalud Alicante and Torrevieja, benchmarks in the treatment of headaches

Quirnsalud has a headache programme in all centeres in the province of Alicante in which headaches are addressed comprehensively. Patients have quick access to a consultant who, from the beginning, guides the patient about their type of headache, carrying out the necessary studies in each case. The program also includes the neurological nursing consultation service in which the patient is educated on pathology, their life habits are analyzed in detail and recommendations are made on what hygienic-dietary measures can help improve their quality of life.

This program also provides the patient with the most advanced treatments such as the administration of Botox for migraine and chronic tension-type headache, the new monoclonals with subcutaneous application for sporadic migraine and the rest of the therapeutic arsenal for less frequent headaches but just as important to alleviate suffering of the patient caused by conditions such as trigeminal neuralgia, occipital neuralgia, cluster headache, etc.

The patient has close contact with the professionals throughout and the health professionals will resolve all doubts quickly and continuously, both in person, by telephone and via email.

More information about headaches can be found in the video

LONG-TERM HEALTH OUTCOMES USING SIMULATION MODEL OF INVESTIGATIONAL LECANEMAB IN PATIENTS WITH EARLY ALZHEIMER’S DISEASE PUBLISHED IN A PEER-REVIEWED…

Posted on April 27, 2022 by Danzig

TOKYO, April 26, 2022 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced an article about long-term health outcomes of its investigational anti-amyloid-beta (A) protofibril antibody lecanemab in people living with early Alzheimer's disease (AD) using simulation modeling was published in a peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to AD and mild AD (collectively, early AD).

Eisai logo. (PRNewsFoto/Eisai Inc.)

The article describes the comparison of the long-term clinical outcomes for the people living with early AD who have amyloid pathology with standard of care (SoC) alone (including stable use of acetylcholinesterase inhibitor or memantine), and with lecanemab with SoC (lecanemab+SoC), using the disease simulation model (AD ACE model1,2) based on the results of a Phase IIb clinical trial (Study 201) evaluating the efficacy and safety of lecanemab. SoC data were estimated from ADNI (Alzheimer's Disease Neuroimaging Initiative) study results. It was shown that the estimated lifetime risk of disease progression to mild, moderate, and severe AD dementia from baseline could potentially be reduced by 7%, 13% and 10% in lecanemab+SoC, respectively, compared to SoC. In the model the mean time advancing to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.51 years (SoC vs. lecanemab+Soc: 3.10 vs.5.61 years), 3.13 (6.14 vs. 9.27 years) and 2.34 (9.07 vs.11.41 years) respectively. Subgroup analysis by age and disease severity at baseline also revealed a potentially greater impact on disease progression with earlier initiation of treatment with lecanemab. The incremental mean times for transition to mild and moderate AD dementia were 2.53 and 3.34 years, respectively, when treating MCI due to AD in a subgroup analysis compared to SoC.

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"With an increasing and aging global population, the number of people diagnosed with Alzheimer's disease will only continue to increase, making it an even more important and urgent public health priority. Alzheimer's disease is growing issue in regard to medical and nursing care costs, but also costs of informal care by family, leading to increased anxiety. The findings from the simulation model suggest early treatment with lecanemab may delay progression to the more severe stages of AD, potentially giving people living with early AD and their loved ones more time together and possibly reducing healthcare costs," said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd. "These predicted and simulated long-term health outcomes provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. Ongoing Phase 3 studies will soon be able to inform the model inputs and refine the findings. As part of Eisai's commitment to our human healthcare mission and transparency, we will continue to publish data and information about lecanemab."

Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the first quarter of Eisai's fiscal year 2022, which began April 1, 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

1 Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: Development and validation. Alzheimers Dement (NY). 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.0012 Tafazzoli and Kansal. Disease simulation in drug development, External validation confirms benefit in decision making. The Evidence Forum. 2018.https://www.evidera.com/wp-content/uploads/2018/10/07-Disease-Simulation-in-Drug-Development_Fall2018.pdf

Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120

[Notes to editors]

1. About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti- A antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain A accumulation (P<0.0001) and slowing of disease progression measured by ADCOMS* (P<0.05) in early AD patients. The study did not achieve super superiority its primary outcome measure** at 12 months of treatment. The Study 201 open-label extension was initiated after completion of the Core period and a Gap period off treatment of 9-59 months (average of 24 months, n=180 from core study enrolled) to evaluate safety and efficacy, and is underway.

Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007.

* ADCOMS (AD Composite Score), developed by Eisai, combines items from the ADAS-Cog (AD Assessment Scale-cognitive subscale), Clinical Dementia Rating (CDR) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.** An 80% or higher estimated probability of demonstrating 25% or greater slowing super superiority in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo.

2. About the Collaboration between Eisai and Biogen for Alzheimer's DiseaseEisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product.

3. About the Collaboration between Eisai and BioArctic for Alzheimer's DiseaseSince 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.

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LONG-TERM HEALTH OUTCOMES USING SIMULATION MODEL OF INVESTIGATIONAL LECANEMAB IN PATIENTS WITH EARLY ALZHEIMER'S DISEASE PUBLISHED IN A PEER-REVIEWED...

Faster accumulation of cardiovascular risk factors linked to increased dementia risk – EurekAlert

Posted on April 27, 2022 by Danzig

EMBARGOED FOR RELEASE UNTIL 4 P.M. ET, WEDNESDAY, APRIL 20, 2022

MINNEAPOLIS Cardiovascular disease risk factors, like high blood pressure, diabetes, obesity and smoking, are believed to play key roles in the likelihood of developing cognitive decline, dementia, and Alzheimers disease. A new study suggests that people who accumulate these risk factors over time, at a faster pace, have an increased risk of developing Alzheimers disease dementia or vascular dementia, compared to people whose risk factors remain stable throughout life. The research is published in the April 20, 2022, online issue of Neurology, the medical journal of the American Academy of Neurology.

Our study suggests that having an accelerated risk of cardiovascular disease, quickly accumulating more risk factors like high blood pressure and obesity, is predictive of dementia risk and associated with the emergence of memory decline, said study author Bryn Farnsworth von Cederwald, PhD, of Ume University in Sweden. As a result, earlier interventions with people who have accelerated cardiovascular risks could be an effective way to help prevent further memory decline in the future.

The study looked at 1,244 people with an average age of 55 who were considered healthy in terms of cardiovascular health and memory skills at the start of the study. Participants were given memory tests, health examinations, and completed lifestyle questionnaires every five years for up to 25 years.

Of all participants, 78 people, or 6%, developed Alzheimers disease dementia during the study and 39 people, or 3%, developed dementia from vascular disease.

Cardiovascular disease risk was determined by using the Framingham Risk Score which predicts the 10-year risk of a cardiovascular event. It looks at factors including a persons age, sex, body mass index (BMI), blood pressure and whether they smoke or have diabetes. Participants started the study with an average 10-year risk between 17% and 23%.

Researchers determined who had an accelerated cardiovascular disease risk by comparing participants to the average progression of cardiovascular disease risk.

Researchers found that cardiovascular disease risk remained stable in 22% of participants, increased moderately over time in 60%, and rose at an accelerated pace in 18% of people.

People in the study with stable cardiovascular disease risk had an average 20% risk of a cardiovascular event over 10 years throughout the study, while those with a moderate increased risk went from 17% to 38% over the course of the study and those with an accelerated risk went from a 23% to 62% increased risk by the end of the study.

Researchers determined that when compared to people with a stable cardiovascular disease risk, people with an accelerated cardiovascular disease risk had a three to six times greater chance of developing Alzheimers disease dementia and a three to four times greater risk of developing vascular dementia. They also had up to a 1.4 times greater risk of memory decline in middle age.

Several risk factors were elevated in people with an accelerated risk, indicating that such acceleration may come from an accumulation of damage from a combination of risk factors over time, said Farnsworth von Cederwald. Therefore, it is important to determine and address all risk factors in each person, such as reducing high blood pressure, stopping smoking and lowering BMI, rather than just address individual risk factors in an effort to prevent or slow dementia.

A limitation of the study was the inability to determine whether the decline leading to dementia is initiated by an accelerated cardiovascular disease risk. Farnsworth von Cederwald said it cannot be ruled out that other factors may also contribute, so more research is needed.

The study was funded by the Swedish Brain Foundation, Knut and Alice Wallenberg Foundation, and Swedish Foundation for Humanities and Social Sciences.

Learn more about dementia at BrainandLife.org, home of the American Academy of Neurologys free patient and caregiver magazine focused on the intersection of neurologic disease and brain health. Follow Brain & Life on Facebook, Twitter and Instagram.

When posting to social media channels about this research, we encourage you to use the hashtags #Neurology and #AANscience.

The American Academy of Neurology is the worlds largest association of neurologists and neuroscience professionals, with over 38,000 members. The AAN is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimers disease, stroke, migraine, multiple sclerosis, concussion, Parkinsons disease and epilepsy.

For more information about the American Academy of Neurology, visit AAN.com or find us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Faster accumulation of cardiovascular risk factors linked to increased dementia risk - EurekAlert

Progress in MS Therapeutic Development and Shifts in the Landscape – Neurology Live

Posted on April 27, 2022 by Danzig

Robert K. Shin, MD: Actually, it's more than a quarter-century as I think about it, right? We're approaching 30 years3 decadesof having approved therapies for multiple sclerosis. And some of the medications that were approved in the early 1990s are still being used today, which is kind of amazing. However, I think that with some of the data that that's been presented now, we're doing more and more head-to-head studies with active comparators. I think we can say that certainly for patients with active MS, we can see that there's a difference. That some MS therapies are more effective than other therapies, I think we should just be honest about that. They're not all created equal. And it doesn't really matter whether we focus on relapse rate or MRI parameters, disability progression, or combining them together into a metric like No Evidence of Disease Activity, whether it's NEDA-3 or, if you incorporate other components, NEDA-4. For the first time, we can say, Oh, if I use drug X over drug Y, I'm going to have a greater chance of seeing no evidence of disease activity.

I think that MS might be not totally unique, but unlike in some other fields of medicine, we have not agreed upon a firstline therapy. We don't have a consensus that when somebody is diagnosed with MS, we should start with drug X, and then if that's not tolerated. That kind of thing, which is common in other disease spaces. We just haven't come to a consensus in this space. But I think that if we look at studies that we're seeing reported out today, and what I think you can really see is that we should be honest and say that there are therapies that are more effective than others, there are strategies that will be more likely to result in shutting down of the disease process than others. Again, in our field, we're still debating sort of the timing of that optimization of our strategy.

But I do think that maybe there's an increasing shift, a recognition, that with the advent of therapies with greater efficacy, at least that option exists. I think more and more people are looking at using them earlier in the disease course rather than waiting until disability is apparent. And so to me, this is a positive shift. One thing I think that's kind of changed even how we think about MS, in terms of its clinical course, is the different disease processes. Because I do think in the past, we really thought in a very binary way. We thought that people would present with a relapsing form of the disease, and you know, heaven forbid that you transition into phase 2, like a progressive form of the disease. As if there's sort of this wide gulf between the two. Hopefully, you would never cross over in that regard. As we've seen at AAN and other meetings, data using different biomarkers, whether it's optical coherence tomography, serum neurofilament light, other biological markers, volumetric MRI, other more investigational MRI markerswhat's the common theme? We're seeing that neurodegeneration occurs from the beginning of the disease process, if not probably before the patient's even aware or the providers are even aware of the diagnosis. I would say, rather than two different stages, we now see them almost as overlapping. We see that there is a progressive neurodegenerative component that is occurring, as best we can tell, probably from the beginning of the disease process that is punctuated by relapses.

My opinion of why we were, I guess, misled is because of the existence of reserve, right? The ability of a young healthy person to compensate for the early stage means that it created the illusion that everything was fine until reserve runs out, and then the progression is more obvious. So to me, this has been the biggest shift in our understanding of the disease process because what this means is that we are developing a heightened sensitivity to any signs of progression. In other words, rather than waiting until somebody suddenly needs to use a cane or walker, what's the focus? Everyone's interested in things like cognition and biomarkers and different things to recognize this component as early as possible, really setting the stage for theoretically, hopefully, another class of therapies that will be to be particularly helpful for that. So there's been this shift, I would say, in sort of our thinking about MS, which I find very exciting because I think this maybe bodes well for the future. But as we discussed earlier, there are still some important steps that are necessary before we'll know how to best address that.

Transcript edited for clarity.

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Progress in MS Therapeutic Development and Shifts in the Landscape - Neurology Live

The Great Resignation: The Workforce Exodus Hits Neurology… : Neurology Today – LWW Journals

Posted on December 8, 2021 by Danzig

Article In Brief

Neurology practices, hospitals, and academic institutions across the country are experiencing severe workflow disruptions as a result of hiring and recruitment challenges post-COVID-19.

Over the past 20 months, many sectors of the health care workforce have suffered extraordinary levels of stress and exhaustion due to the COVID-19 pandemic. This has resulted in massive departures of physicians, advanced practice providers (APPs), nurses1, technicians, medical assistants (MAs), research assistants, administrative assistants, and other employees.

According to a survey by Morning Consult, which polled 1,000 U.S. health care workers in early September, nearly one in five had quit their jobs during the pandemic, and one in five of those remaining had considered leaving. The exodus has placed downstream pressure on the remaining staff, who are often asked to bear an increased workload, creating a domino effect on the outflow of employees.

The causes for these departures are complex and multifactorial. They have been attributed to the effect of vaccine mandates on those unwilling to get vaccinated, illness related to COVID-19 or its sequelae, and severe burnout and other psychological consequences triggered by the pandemic. More broadly, COVID-19 has caused health care professionals to reevaluate what they find meaningful in life, to examine whether they feel sufficiently valued in their workplaces, and to consider alternative positions or even professions. Many ultimately end up leaving for higher pay and better opportunities.

As a result, neurology practices, hospitals, and academic institutions across the country are experiencing severe workflow disruptions. So ubiquitous is this crisis that one might ask who in our profession has not been impacted, rather than who has.

Neurology Today spoke to several neurologists and business administrators who provided examples of how the employment shortages have affected their departments and practices across the country.

Randolph W. Evans, MD, FAAN, a solo practitioner in Houston, who has practiced general neurology and headache medicine for the past 39 years was unable to find an MA after two left in April 2021. Prior to the pandemic, a listing in Indeed by his practice would have elicited a robust response of qualified assistants, but in April he received responses from 73 unqualified applicants, despite posting a two-year experience requirement. (Candidates included a canine coach, bus driver, waitress, sales associate, babysitter, school volunteer, housekeeper, security officer, music school coordinator, and a preschool teacher.)

Five people worked in the office for less than two weeks each and did not work out, said Dr. Evans, who tried to do the best he could by hiring nursing students who proved to be unreliable or left the position for better pay. Another new hire resigned due to the vaccine mandate and one person never showed up at all.

After I lost an MA due to illness and another due to a family relocation, it created big problems for me, but it was nothing compared to our regional hospitals, which have been very short-staffed and overwhelmed during waves of COVID over the last few months, he added.

Recruiting for nurses, APPs, and MAs is somewhat similar to the post-COVID housing marketa seller's marketwith owners receiving multiple offers that end up increasing the selling price, said Bryan Soronson, MPA, FACMPE, CRA, senior administrator in the department of neurology at the University of Maryland School of Medicine- in Baltimore, who has not previously witnessed such market forces in his 36 years of work in the department.

These job searchers are offered additional salary, benefits and other goodies, and usually take the highest offer.

Recently we had two vacancies for MAs; on two consecutive occasions, candidates accepted the position, gave notice, and two to three days before the start date contacted our clinic director stating that they decided to take another position that paid a higher salary, he said. We then went to a temporary agency that was supposed to send two new MAs but only one showed up, noting that the lack of consistent MA staffing is an ongoing challenge which is negatively impacting clinic operations and efficiency as well as patient satisfaction.

Many large medical systems are behind in providing competitive salaries and this is becoming an ongoing spiral, Soronson said. Once a market adjustment is made, other medical groups further increase their salaries, a treadmill that continues to be pushed faster.

There have been workplace shortages throughout the pandemic and our clinic and hospital, like many others, have been working very hard to cope, said neuromuscular specialist, Anne Louise Oaklander, MD, PhD, FAAN, director of the Massachusetts General Hospital Nerve Unit & Neuropathology Skin Biopsy Service in Boston, Massachusetts. But I hadn't expected to lose one of two histotechnologists in my neurodiagnostic skin biopsy lab with two weeks' notice, particularly with the workload becoming so heavy in 2021, explaining that the sudden resignation was a result of a hospital-wide vaccine mandate.

Clinical diagnostic labs still have specimens arriving even if the lab is short-staffed. My one remaining technologist has been working sometimes seven days a week and until midnight to try and catch up, Dr. Oaklander said. Clinical testing labs are disproportionately affected by loss of technologists as there isn't a pool of trained EEG, EMG, histotechnologists, and intra-operative monitoring techs looking for jobs..

Dr. Oaklander said the loss of their team members affected the remaining staff emotionally, herself included, because they worried about how departed staff members would support their families, given that mandated resignation makes employees ineligible for unemployment benefits.

We have not experienced this degree of personnel loss in any given year in my 14-year tenure, said Vinny Kaur, MPH, senior clinical department administrator in the department of Neurology at the Texas Tech University Health Sciences Center in El Paso. In Texas, no entity has allowed state-based institutions to mandate vaccines to date (although this may change on January 5) so we have not lost neurology personnel for this reason so far..

Kaur, who performed exit interviews on all departed staff, said, After a campus-wide restructuring in January 2021, a new centralized billing department lost more than half its billers and coders within ten months, including five of six neurology personnel.

One chose retirement, another with childcare issues decided to be a stay-at-home mother, and three changed their line of work and transferred to other departments. The clinic structure was also reorganized leading to the departures of a manager who decided to pursue an RN degree and a cashier and authorization personnel who left for jobs in the community. (MAs also left due to a variety of reasons.)

We used a combination of strategies to fill the positions, including utilizing interns and temporary agencies, outsourcing coding and billing, and turning to internal hires and promotions, said Kaur. But we experienced no shows for interviews and also ended up reopening positions for a long period of time, since we did not have a robust pool of candidates applying.

While staff had a multitude of other reasons for leaving, Kaur explained that the duration of unfilled positions has been compounded by a very lengthy hiring process at her institution.

The range of staff issues, which have impacted clinic operations, has included burnout due to overtime requirements, human error due to fatigue, and a pervasive inability to catch up with daily operations, she noted. In addition to permanent staff loss, the department of neurology has been struck by temporary staff losses due to FMLA [Family and Medical Leave Act] issues and illnesses, which has made this an extraordinarily challenging time. This unfortunately has hampered the provision of effective service to our patients.

The scientific community has been hard hit over the past year due to serial obstacles serving as impediments to research which could cripple science for some time to come. A perfect storm of adversities has ensued from the pandemic, including the loss of clinical coordinators and related personnel, supply chain shortages, and barriers to patient enrollment, including prolonged travel fears and telemedicine regulatory roadblocks.

Neuro-oncologist Maciej M. Mrugala, MD, PhD, MPH, FAAN, professor of medicine and director of the Comprehensive Neuro-Oncology Program at Mayo Clinic in Phoenix, has been witnessing difficulties with retention of research coordinators. It's hard to provide exact numbers, but we have been plagued by high turnover rate with departures from the clinical research core, he said.

He suspects that many left for better opportunities within the institution or elsewhere, with improved work schedule and/or pay. I think most feel overworked and underappreciated, he said. This is a high-stress work environment that calls for excellent navigation skills and an ability to multitask and meet tight deadlines.

The departures have impacted day-to-day operations with periodic halts in enrollment into trials due short staffing. This is concerning, particularly in my field, neuro-oncology, where clinical trials are a vital part of treatment strategy, and patients don't have time to wait as prognosis is poor and disease progresses rapidly, he explained. Situations like this can lead to potential problems providing appropriate follow up of study patients and may threaten protocol compliance and data integrity.

Dr. Mrugala pointed out that this is a nationwide problem. Clinical research specialists/coordinators are vital parts of the team and scientific progress can't be achieved without their involvement, he said. They must be recognized for their work and treated and compensated appropriately, so that their retention will improve.

To compound the dearth of research assistants, the pandemic has led to a loss of study patients who are averse to travel. Until now telemedicine filled the gap, said Bruce Cohen, MD, FAAN, director of the NeuroDevelopmental Science Center at Akron Children's Hospital in Ohio. But as states rescind the waiver for telemedicine licenses, it may no longer be legal for us to practice medicine across state lines without obtaining a license in that state, Dr. Cohen explained.

We went from a time prior to COVID-19 when patients got on a plane at the expense of a pharmaceutical sponsor to take part in a clinical trial to a pandemic when we learned how to conduct research safely by telehealth with the assistance of their local doctors, laboratories, and visiting nurses, he said. And although we have patients who are still reluctant to travel, state license waivers are being rescinded removing telemedicine as a viable alternative option.

Patients will be difficult to recruit for new trials if they continue to avoid getting on planes, he said, adding that this may slow development of new therapies for some time to come.

The worst-case scenario for patients currently enrolled in trials is that they will not be able to receive the drug/device and lose the opportunity entirely. To avoid that we are scurrying around trying to identify accredited visiting nurses in their communities who are research-qualified to assist us, Dr. Cohen said. Furthermore, if we are unable to complete trials, industry stands to lose years of work and millions of dollars of their investment, an especially dire situation for smaller pharma companies who may not be able to recover and for new treatments for serious illnesses.

Finally, supply chain shortage has impacted not only consumer household goods but laboratory supplies. Research labs across the country are running low on plastic lab materials such as gloves, pipette tips, reagents, centrifuge tubes and other essential items for which they are waiting longer and paying more. Several neuroscientists cited shortages in cryotubes, commonly used for cryogenic storage of biological materials using liquid nitrogen, including the preservation of serum, blood, and cells.

This six-month long shortage is impeding an NIH-sponsored multi-institutional trial at our institution, said Dr. Cohen. Two patients this week who wanted to participate in the trial were turned away due to shortages of these containers.

Justin T. Jordan, MD, MPH, who serves as clinical director of the MGH Pappas Center for Neuro-Oncology and director of the MGH Family Center for Neurofibromatosis (NF) in Boston, said that his current administrative assistant is pulled in more directions than ever, working with more physicians and doing additional non-secretarial work to support hospital and patient needs. Indeed, she is the fourth secretary he has had this past two years due to multiple departures.

During the pandemic, telemedicine opened a unique door to see NF patients during virtual visits, he said. But now that state license waivers have been rescinded, that door has been closed again.

This regulatory roadblock acutely affects people with rare diseases, who typically must travel a significant distance for care, he explained, having studied aggregate data on patient access to care reported by patients and specialty NF clinics between 2008 and 2015.

He found that geographic access to care is particularly limited for adults, patients with rarer conditions, and patients in the Western U.S.2

Dr. Jordan is currently applying for a license in New Hampshire so that he may continue to care for patients who reside there. The process has been laborious and disruptive and even with the available secretarial assistance he has, there were many things only he could do.

For example, I had to go out to get ink fingerprinted this week, he said. The administrative burden of completing an application for a new license is so high that it leaves me with little desire to accumulate licenses from other states, he said.

Neurology Today reached out to Paul B. Ginsburg, PhD, professor of health policy at the Sol Price School of Public Policy at the University of Southern California in Los Angeles, California, who also serves as vice chair of the Medicare Payment Advisory Commission, to understand what is happening to the labor market and to ask how long the current workforce departures may last.

Dr. Ginsburg, who has spent his career studying changes in the financing and delivery of health care and the evolution of health care markets is particularly intrigued by a behavioral economics explanation for the workforce resignations, particularly those in low-wage jobs.

It suggests that that the pandemic caused many employees, typically comfortable with the status quo, to look into alternative positions, he explained.

This gets reinforced when they see others changing jobs to get higher pay and possibly more satisfying work, he added.

People often have little information about employment alternatives, but the pandemic motivated them to look more, he said. The pandemic has also caused people to do serious rethinking about where they are in their lives, often triggering a move to make a change.

Dr. Ginsburg expects that as COVID-19 gets under control and the infection rates go down, some of the precipitants of departures will recede as people get used to a new status quo. A winding down of the pandemic will also allow more individuals to work; for example, when more children get vaccinated and schools are open more consistently, some parents will be able to return to work.

Medical facilities are responding to labor shortages by reducing services delivered and likely some will affect patient health, while others will not.

It is said that about a third of medical care does not produce value, so with pressure to do less due to workforce constraints, wasteful services may be abandoned, Dr. Ginsburg explained. Over time, this will lead to even faster consolidation in health care delivery.

Many economists believe that much of the economy-wide inflation is temporarycaused by large shifts in spending away from services towards goods.

People are already starting to shift back; they are rejoining gyms and acquiring less home exercise equipment, said Dr. Ginsburg.

But the higher wages that came from greater willingness of workers to look at alternatives will stay with usand this may be a good thing, he concluded.

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The Great Resignation: The Workforce Exodus Hits Neurology... : Neurology Today - LWW Journals

Longer Decompression Time and Early Transport Time After Spinal Cord Injury Are Linked to Higher Impairment… – Physician’s Weekly

Posted on January 29, 2022 by Danzig

For a retrospective cohort study, researchers wanted to determine if there was a link between early decompressive surgery and the influence of transport time on traumatic spinal cord injury (tSCI) patients neurological outcomes. tSCI was a life-changing incident leaves a person permanently unable or unable to function. There was a lot of debate over when the best time is for surgical decompression in tSCI patients. The goal of the research was to compare the neurological results of tSCI patients who had early vs. late surgical decompression and the effect of transit time on neurological outcomes. A total of 84 patients with tSCI who required surgical decompression were studied. Time to decompression classification cutoffs was determined using regression analysis. The following subgroups of patients were identified: As a percentage of total or admitting hospital time to decompression, 0 to 12 or greater than 12 hours. It was discovered how the American Spinal Injury Association Impairment (AIS) Grade changed from admission to discharge. In addition, the influence of transport duration on AIS grade conversion was evaluated, with patients being divided into 2 groups: those who travelled for less than 6 hours and those who travelled for more than 6 hours. Confounding factors such as age, injury severity, and AIS grade had no significant differences (P>0.05) among the time to decompression subgroups. Patients who got decompression within 0 to 12 hours had considerably (P<0.0001) better average ASIA grade improvements (0.76). Patient transport periods of fewer than 6 hours were linked to a significantly larger conversion of AIS grade to less impaired states (P=0.004). According to the findings, decompression within 12 hours and short transport periods (<6 hours) are linked to significant improvements in neurological outcomes.

Link:journals.lww.com/spinejournal/Abstract/2022/01010/Early_Decompression_and_Short_Transport_Time_After.10.aspx

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Longer Decompression Time and Early Transport Time After Spinal Cord Injury Are Linked to Higher Impairment... - Physician's Weekly

20 Years Later, Neurology Training Transitions with New… : Neurology Today – LWW Journals

Posted on November 7, 2021 by Danzig

Article In Brief

Neurology residency directors reflect back on the way training has shifted in the last 20 yearsfrom training and work limits for residents to new models for assessing skills.

With the understanding of a host of neurologic diseases growing at an impressive pace, neurology residency programs have plenty of new discoveries and topics to consider.

Just 20 years ago, stroke care was in its infancy and neurologists were only starting to experience the potential of tissue plasminogen activator (tPA) to limit the devastating effects of acute stroke. Now with the introduction of mechanical thrombectomy, stroke care has evolved even more, as have therapies for everything from multiple sclerosis (MS) to epilepsy.

It used to be that residency programs could teach residents the field of neurologythis is what's out there and this is what you should know is comingbut now that's impossible, said Shannon M. Kilgore, MD, FAAN, who serves as the site director of the Stanford University neurology residency program. The depth and breadth of neurology is so big at this point that there is no way to cover everything.

Exposing residents to a spectrum of neurologic diseases and degrees of illness remains at the heart of clinical rotations in neurology training, Dr. Kilgore said, but there also is a shift toward the goal of creating learners, life-long learners. It's about teaching trainees how to access information, how to recognize when they don't know something and seek out information from someone else or another resource.

Other key changes in neurology training in recent years include limitations on how many hours residents can work each week (80 is the magic number); the use of milestones to track residents' advancement through levels of mastering skill sets (such as diagnosis and management of neurologic emergencies); and more attention to broader societal issues such as diversity, inclusion, cultural awareness, inherent bias, and health care access and inequities.

A lot has changed and a lot has not changed, said Ralph Jzefowicz, MD, FAAN, who at the end of this year will step down after 25 years as program director of the neurology residency program at the University of Rochester School of Medicine and Dentistry.

On the change side, Dr. Jzefowicz said neurology is shedding its image of being a kind of laid-back specialty where there isn't much for practitioners to do besides making diagnoses and managing symptoms as best they can. When he began training residents, stroke was not considered a medical emergency, and largely involved admitting a patient to the hospital, providing physical and occupational therapy, and transferring the patient to a rehabilitation facility or a nursing home depending upon the severity of the neurologic deficit.

Dr. Jzefowicz, professor of neurology and medicine, said, What hasn't changed is the aim to turn out residents who are physicians foremost with the knowledge to care for patients with neurologic disorders, outstanding teachers, as well as leaders who are kind, compassionate, and have humanistic skills.

Pierre Fayad, MD, FAAN, FAHA, who served as neurology residency program director for more than 12 years at the University of Nebraska Medical Center and is currently a member of the neurology residency review committee for the American Council for Graduate Medical Education (ACGME), said, The key shift in neurology training, as in other specialties, has been to move away from a very structured, prescriptive approachthe prescriptive do these rotations, cover these core subjects toward assessing a training experience focused on clinical competencies and milestone achievement.

There are various milestones for what we feel are important things for a neurology resident to achieve in training, said Dr. Fayad, professor of neurological sciences and chief of vascular neurology and the stroke division of the University of Nebraska Medical Center. Assessing residents using 27 milestones, which began in 2013 and was updated this year, gives us a much bigger and better picture of the progress of residents, he said.

The 27 milestones, grouped under six major domains of physician competency, are each rated from 1 (novice) to 5 (expert). For instance, in a milestone for Interpretation of Neuroimaging, residents advance from Level 1 (identifies basic neuroanatomy on brain and vascular anatomy of the head and MRI and CT) to Level 5 (interprets advanced neuroimaging).

The specialty of neurology has grown tremendously because of the massive expansion in knowledge and therapeutics that led to subspecialization within neurology to carry forward the science and clinical practice, said Dr. Fayad, who noted there are now 10 ACGME-approved neurology subspecialties and many others that are not yet approved by the ACGME.

A big challenge for the neurology residency is parceling out the knowledge from each of the subspecialties and integrating them to a general neurologist's need, he said. An example is incorporating some of the critical content and practice from endovascular surgical neuroradiology into the neurology residency. Other subspecialties with such challenges include MS and neuro-oncology, which require a significant knowledge and comfort with managing immune therapies, or movement disorders and epilepsy, which are heavy in surgical therapies, procedures, and pharmacotherapies.

He said telehealth, which became quite common in neurology during the early months of the pandemic, will eventually need to be officially incorporated into neurology residency training.

Dr. Fayad said residency directors have a lot of balls to juggle: They need to consider the professional interests and goals of individual residents, the on-call demands of a given servicevascular and endovascular neurology require availability 24 hours a day on an urgent basiswhile other specialties do not have such needs, the impact of urgent calls on residents' well-being, and compliance to the 80-hour work requirement.

Carlo S. Tornatore, MD, professor and chair of neurology at Georgetown University Medical Center, was residency director from 1998 to 2015. He believes the decision to limit residents' hours has led to mostly positive results, though he said there needs to be extra attention on good communication when handing a patient off from one doctor to the next. The adoption of electronic medical records helps.

There is no question that work hours are more humane and respectful of our learners, and the whole purpose of residency is to learn, he said.

Dr. Tornatore said that with advances in stroke care, spending time on stroke service is all the more critical for residents, but he said inpatient, acute-care experience shouldn't be emphasized at the expense of outpatient services because that is where most neurologic care is delivered.

Our goal is to train somebody who is highly competent as a general neurologist and who can easily pass the boards, he said, though most residents do go on to specialty training.

I think a general trend (in training) has been to have residents spend more time in the outpatient setting, he said, which helps connect residents with the everyday practice of neurology and the dynamics outside the walls of the hospital.

Dr. Tornatore, who specializes in MS, said the COVID-19 pandemic brought front and center to his residents the pressing issue of health disparities and inequities in health care access in low income and minority communities.

What we learned during the pandemic is that lack of access to care and the incredible inequities in care absolutely had an impact on patients' risk of developing COVID-19 or being hospitalized and dying from COVID, he said. He said part of medical education and training has to focus on what doctors can do within their institutions and communities to address health inequities and disparities, including being cognizant of the inherent biases they may bring into patient encounters.

It's getting at the idea that when you see a person don't immediately jump to the conclusion, I know this person and what they are about, he said.

He said Georgetown University Medical Center has undertaken multiple initiatives to address issues of diversity, inclusion, and equity, including the establishment of the Racial Justice Committee for Change, which consists of attending staff, fellows, residents, medical students, patients, and staff. Dr. Tornatore said the committee has been tasked to make tangible and meaningful changes over the next year to address diversity, inclusion, and equity concerns.

Wendy Peltier, MD, associate professor of neurology and medicine at the Medical College of Wisconsin, said she wonders whether the holistic side of being a doctor is being shortchanged amid the need to teach all sorts of new developments in neurology while still keeping training hours in check.

I think it is important for medicine as a whole to have a broader approach for doctors in training, to focus on not just what they learn but how they grow as humans, she said.

Dr. Peltier, who was neurology residency director for a decade and now specializes in palliative care, said she's not advocating a return to the days when she once worked 100 days in a row as an intern during the HIV/AIDS epidemic, but said today's trainees may be perhaps missing a little of that lived and shared experience with a patient.

I can look back and say my (training) experiences brought me so close to patients and families and made me the doctor I am today, she said. The joy I got from the patientdoctor relationship empowered me to stay active in neurology.

Dr. Peltier said that one trend in neurologic care that she finds particularly exciting is the growth in using multidisciplinary care teams in field such as amyotrophic lateral sclerosis, MS and memory care, so there needs to be an emphasis on residents learning how to be a leader of a team.

Stanford's Dr. Kilgore, who has served on the ACGME's Review Committee for Neurology, said neurology training of the future needs to be organized in such a way to help address the unmet need for neurologists in many communities, including rural America, which contributes to inequities in care.

Training is inherently tied to hospital care [due to Medicare funding of GME], but we have historically woefully undertrained in the outpatient clinics, she said. Residents are really uncomfortable going into practice where they are going to see patients mostly in a clinic because that's not what they've been doing for four years.

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20 Years Later, Neurology Training Transitions with New... : Neurology Today - LWW Journals

Experts stark warning over wave of neurological illness to follow Covid infections – Express

Posted on December 8, 2021 by Danzig

The chronic and short-term complications of coronavirus have remained in sharp focus throughout the pandemic. But as research advances, its becoming increasingly apparent that certain patients find their brains continue to bear out the scars of their COVID-19 battles. Data released last year raised the alarm over the cases of three young COVID-19 patients who developed Parkinson's within weeks of contracting the virus. An expert has now warned that many more could be at the perils of the neurodegenerative condition in the coming years.

Kevin Barnham from Florey Institute of Neuroscience and Mental Health warned that a wave of neurological illness is set to follow the pandemic.

Parkinsons disease is a complex illness, but one of the causes is inflammation, and the virus helps to drive that inflammation," explained Miss Barnham.

Once the inflammation gets into the brain, it starts a cascade of events which can ultimately lead to Parkinsons disease.

Evidence is already suggesting the triggers for Parkinsons disease are there with this virus. I believe the risk is real.

READ MORE: Parkinson's: Exactly how much water you should drink to avoid Parkinson's symptoms

We cant put a number on it, but with 30 million people worldwide affected by this virus, even a small shift in the risk of getting Parkinsons would lead to many more people getting diagnosed.

We know COVID-19 has short-term effects, but we are releasing more about the potential long-term effects.

Data published in November of 2020 were the first to raise the alarm over potential neurological implications of infection with COVID-19.

The data drew on three separate case reports on relatively young COVID-19 patients who developed Parkinsons within two to five weeks of contracting the disease.

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The lead author of the article, Patrik Brundin, warned at the time: If this link is real, we might be in for an epidemic of Parkinsons disease in the future."

The three patients, aged 35, 45 and 58-years-old respectively, all incurred a severe respiratory infection from Covid, which led to their hospitalisation.

Brain imaging later revealed classic signs of Parkinsons disease in all three patients.

These cases of acute Parkinsons in patients with COVID-19 are truly remarkable," noted Mr Brundin.

They occurred in relatively young people - much younger than the average age of developing Parkinsons - and none had a family history of early signs of Parkinsons prodrome. That is quite a stunning observation.

Parkinsons is normally a very slowly developing disease, but in these cases, something happened quickly.

The doctor suggested the virus might make patients susceptible to Parkinsons by plaguing them with neurological symptoms after infection.

These typically include brain fog and depressions, which are consistent with damage to the brain and could lead to Parkinsons.

Parkinson's disease is characterised by a gradual shortfall of dopamine in the brain, the hormone responsible for movement in the body.

This causes problems with body movement, including involuntary tremors and rigidity, both of which can severely compromise quality of life.

In light of the alarming findings, researchers have suggested patients undergo early tests to pick up symptoms.

Parkinsons patients can experience loss of smell up to a decade before the onset of symptoms, so a smell-test screening could open up the window opportunity for early medical intervention, explained doctor Lyndsea Collins-Praino, Head of cognition ageing laboratory at the University of Adelaide.

Doctor Collins-Praino, added: The earlier we can detect [the damage] the better our chances of really effective and meaningful therapeutics for individuals.

Read the rest here:
Experts stark warning over wave of neurological illness to follow Covid infections - Express

He was told he had the N.B. ‘mystery illness.’ But a 2nd opinion says no as doubts swirl about diagnoses – CBC.ca

Posted on November 7, 2021 by Danzig

When Luc LeBlanc received a phone call from his family doctor in March 2021 telling him he had a neurological illness and it was terminal his world crumbled.

"I knew I had something wrong cognitively," said LeBlanc, 41, of Dieppe, N.B. "I was falling, I was having multiple episodes of passing out and cracked three ribs. I reached out to my family doctor to say, 'We need to push neurologists any way possible because I can't live like this.' "

LeBlancbecame part of a cluster of 48 New Brunswick residents diagnosed with a neurological condition of unknown cause, a medical enigma dubbed a "mystery illness."

He kept pushing, however, for a second opinion and last week travelled to Toronto for an appointment at the University Health Network's Krembil Brain Institute.

After about 16 hours of assessments over three days with neurologists and neuropsychologists, he had some answers.

"The good news for Luc is that we can say that he doesn't have this rapidly progressive neurodegenerative disease," said Dr. Lorraine Kalia, a neurologist and scientist specializing in Parkinson's disease and movement-related disorders.

WATCH| A patientdescribes his symptoms:

Kalia is quick to caution that "all we can speak to is Luc," noting he is the only person from those in the cluster whom they've assessed. There's no doubt LeBlanc has a lot of neurological difficulties, she said, but they are likely related to a concussion he suffered in 2018, as well as anxiety he has been dealing with throughout his life.

While last week's diagnosis gave LeBlanc some understanding of his own condition, questions remain about whether the cluster actually exists.

Those questions also come as concerns heighten inside and outside the provincial government over longstanding shortcomings many see in New Brunswick's health-care system.

"We need more recruitment. We need better retention of physicians, but we also need the dollars put in place to enhance the health-care system," said Mark MacMillan, president of the New Brunswick Medical Society, the professional association for doctors in the province.

"Access could certainly be improved. Wait times are too long for many appointments that need to be seen by a specialist, but that's not just a problem in New Brunswick," he said, noting it's a problem across Canada that needs to be addressed by increasing health transfer dollars from the federal government to the provinces.

From late 2019 onward, LeBlanc and 47 other New Brunswick residents were identified as being part of a cluster of patients with a "progressive neurological syndrome of unknown etiology." That cluster was first identified by Moncton neurologistDr. Alier Marrero. The people range in age from 18 to 85. They are men and women, with the majority living in Moncton.Others arein the Acadian Peninsula and on the north shore, close to the Quebec border.

The first case was retroactively discovered by Marreroin 2015. By 2019, there were 11 cases displaying similar symptoms. By the following year, the count doubled to 24. By June 2021, 48 people were identified, the vast majority by Marrero. Six of the cluster had died.

In March 2021, news of the cluster made headlines after a memo from the province's chief medical officer of health to physicians and other health-care professionals was leaked to the media.

"If you have patients who you feel may meet the case definition for this novel neurological syndrome, please send a clinical referral to Dr. Alier Marrero at the Mind Clinic," the memo said. The clinic is run out of The Moncton Hospital.

The symptoms were similar to Creutzfeld-Jacob disease (CJD), a rare and fatal brain wasting disorder, and included visual hallucinations, muscle twitching and aggression.

An interim reportreleased last week by the New Brunswick government revealed the number of deaths had risen from six to nine and that there were no known factors such as food, place of home or work that could be linked between the cases.

Autopsies for those who died revealed findings including Alzheimer's, Lewy body dementia and cancer, and, according to Health Minister Dorothy Shephard, represent a group of "misclassified diagnoses."

Shephard told The Fifth Estateprovincial health officials reporting that there was an unknown neurological illness "was really a little premature." In her opinion, she said, she does not believe there is a cluster.

More clinical review is necessary, she said, and another report will be released in January.

As LeBlanc watched Shephard speaking last week, he said the province needs to be open-minded to a new disease.

"They don't want to create panic, but they create panic."

At the centre of the unknown illness is Marrero, a neurologist in Moncton. Born in Cuba, he received a medical degree from Universidad Nacional Pedro Henrquez Urea in the Dominican Republic in 2000. He completed his residency in neurology at Laval University in Quebec in 2010.

That same year, Marrero moved to Moncton, where he helped identify the province as having some of the highest rates of multiple sclerosis in Canada. Marrero had concerns about how New Brunswick was relatively underserviced in terms of MS research and the difficulty sufferers had in gaining access to care.

His work led him to cross paths with scientists at the Creutzfeldt-Jakob Disease Surveillance System an arm of the Public Health Agency of Canada. With their input, dating back to 2019, he began developing a case definition for a "progressive neurological syndrome of unknown etiology" theunknown illness he was diagnosing in patients.

While Marrero accepts he could be wrong, he says he is convinced there is a cluster and that the diagnoses from the autopsy findings should not rule that out.

Watch |N.B. neurologist wants patients to feel hopeful:

"Complex problems don't have easy solutions," he said in an interview with The Fifth Estate. "I am confident we will find the cause and we will find a way of dealing with it, hopefully a treatment, hopefully a way of avoiding it."

Jill Beatty, who was told her father was part of the cluster, describes Marrero as an empathetic and calm presence in their storm. Her trust in Marrero has not wavered.

"We were so scared, and we had no idea what we were dealing with."

Marrero has diagnosed 48 people, but said he is treating more than 100 patients with symptoms at the Moncton clinic.

"As a physician, I try to open to them a door of hope that is meaningful hope. And as a scientist, I'm interested in discovering what is causing this problem."

Like many people in the cluster, LeBlanc has had difficulty navigating the health-care system.

Three years ago, he was in a car accident and suffered a concussion. He began experiencing mobility and balance issues, muscle spasms and brain fog. His world spiralled downwards, and he hasn't worked since. He had to wait two years to see a neurologist.

"I think that demonstrates a lack of access to neurology that we all experience across the country," Kalia said after LeBlanc's assessment in Toronto.

As part of LeBlanc's earlier treatment, he did physiotherapy for at least seven months, but saw no improvement. A visit to his physician landed him in Nova Scotia to see an eye doctor specializing in head trauma. He was given prism glasses and told to go to a specialized physiotherapy facility in Amherst, N.S.He had one appointment and then COVID-19 hit. His remaining appointments were virtual.

"It just wasn't the same."

In interviews with The Fifth Estate, several people within the cluster and those who wonder if they have the unknown syndromedescribe long waits to see specialists. Often, they feel they are dismissed by practitioners and left with nowhere to turn.

A discussion paper released by the New Brunswick government earlier this year outlines a need for better patient-centred care, including shorter wait times for surgery and faster access to appointments.

The report said while 90 per cent of New Brunswickers have a family doctor, only 55 per cent are able to get an appointment within five days.

As his cognition declined, LeBlanc said he couldn't get a clear diagnosis or a practitioner who had the time to "look at the full picture. Somebody dropped the ball somewhere."

LeBlanc met Marrero in January 2021, and by mid-March he was told he was part of the cluster.He started making end-of-life plans: extra life insurance, care for his children and lookingfor a coffin.But one thing stood out to him: he was not physically declining like others in the cluster.

He had reached out to one of the youngest, Gabrielle Cormier, 20, and could see the intensity of symptoms was different. He could drive and dress himself. His memory wasn't too bad. He could go to the gym and lift light weights.

Meanwhile, Cormier, of Dalhousie Junction, once an avid skater with dreams of becoming a pathologist, was walking with a cane and sometimes relying on a wheelchair.

The difference between his symptoms and Cormier's, coupled with his family's doubt, left him uncertain. LeBlanc asked Marrero why he was a "confirmed case."

"It's kind of hard when, you know, a lot of people are saying it's all in your head, but is it?"

When asked by Radio-Canada's Enqute about LeBlanc's case, Marrero said he could not comment.

While LeBlanc had his doubts about being part of the cluster, some neurologists, including Dr. Valerie Sim, believe a detailed review of cases of those identified with the unknown neurological illnessis paramount.

"My goal in raising skepticism is simply to balance the discussion," said Sim, a professor of neurology in the Centre for Prions and Protein Folding Disease at the University of Alberta. She said an open mind must be kept to the possibility that there isn't a syndrome.

The extreme age range of those who were diagnosed with the unknown illness and their broad symptoms make it impossible to conclude anything, she said.

"Are we doing them a disservice by assuming that they all fit into the same pocket? Or could they actually have separate things which each might require different investigations and different treatments?"

Kat Lanteinge, a Toronto-based public health advocate, has concerns that while the N.B. government focuses on the lack of links between cases, the search for a root cause will be overlooked.

"When you start drafting a narrative and you start shutting out the experts, so no science can happen, those are massive ethical boundaries that are being crossed."

Marrero, however, still believes a cluster exists.

"I'm ringing a bell," he said, quoting his favourite musician, Leonard Cohen. "He said there is a crack in everything, that's how the light gets in. It's a truth for anything new in science. And I hope [the light] will."

While LeBlanc may have another diagnosis, that doesn't eliminate so many questions that exist around the mystery illness.

"It's hard for us to make conclusions about what we weren't a part of," said Kalia, the Toronto neurologist. "We didn't see Luc as a team two years ago. And so it's hard to know what kind of pieces to the puzzle his physicians had at that point in time to make that conclusion."

As for LeBlanc, he describes a weight lifting off his shoulders. He has gone from believing his life was ending to imagining possibilities. "It's a big shock."

He also vows to continue supporting people he has met through a social media support group for those who have received a diagnosis of the unknown illness, for their friends and family and others who believe they may have it.

"I'm lucky. I was dying. Now I'm not. But I want to help and support people if they want to talk."

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He was told he had the N.B. 'mystery illness.' But a 2nd opinion says no as doubts swirl about diagnoses - CBC.ca

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