Joseph F. McGarvey Jr., MD, FACC | Interventional …

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Certifications

Board Certified: Cardiovascular Disease

Cardiovascular Disease, Interventional Cardiology

Doylestown Health Physicians

Medical School: Georgetown University School of Medicine

Residency: University of Massachusetts Hospital

Fellowship: Cardiovascular Disease, Cleveland Clinic Foundation; Interventional Cardiology, Presbyterian Medical Center

Male

English

Joseph McGarvey, MD, has been recognized by Philadelphia Magazine as a Top Doc for 2018-2019.

Dr. McGarvey is an Interventional Cardiologist specializing in emergent stenting for acute heart attacks. His areas of expertise include treatment of peripheral vascular disease (PVD), cardiac catheterization, carotid stenting, intra-arterial thrombectomy (IAT) treatment for acute stroke, ventricular device implantation, and AAA stent grafting for abdominal aortic aneurysms, as well as coronary stenting for acute heart attacks.

Dr. McGarvey is active in the treatment of structural heart disease and the implantation of the Watchman device for AFib patients that has the added benefit to patients who cannot tolerate blood thinners. He performs Patent Foramen Ovale (PFO) closures for patients with strokes and a hole in their heart. He joined the practice in 1996 and currently runs an active clinical research program.

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Skin tingling, neurological disorders: New unexpected COVID-19 symptoms revealed – Information-Analytic Agency NEWS.am

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The main symptoms of COVID-19 were known as coughing, shortness of breath, and fever. But recently, more and more it becomes known about new other symptoms of coronavirus infection.

According to Dr. Daniel Griffin, a physician-scientist board certified in Infectious Disease, the phenomenon of paresthesia can be a sign of coronavirus infection.

As the New York Post noted, this disorder is well known to people suffering from diabetes and some autoimmune diseases. However, some patients with COVID-19 complained of the same symptoms (feelings of burns, pricks from needles, light electric shocks on the skin).

The antibodies that the body uses to protect against COVID-19 infection can disrupt the nervous system, causing unusual, not very pleasant, sensations, he noted.

Coronavirus infection can have other neurological symptoms, including tingling or numbness in the arms and legs, according to Harvard Health.

Experts name the following neurological disorders, which may be symptoms of a coronavirus infection:

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Skin tingling, neurological disorders: New unexpected COVID-19 symptoms revealed - Information-Analytic Agency NEWS.am

COVID-19: Advice from CDC Neurovirologist and… : Neurology Today – LWW Journals

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By Orly Avitzur April 16, 2020

A neurologist with the CDC discusses what's known to date about COVID-19 and what neurologists should be especially alert to.

On March 19, Neurology Today caught up with AAN member, James J. Sejvar, MD, a neurologist and epidemiologist at the US Centers for Disease Control and Prevention (CDC), who has been working on COVID-19 since early January when the first reports of illness were announced in China. In 2009, Dr. Sejvar he asked the AAN to collaborate with the CDC in reporting cases of Guillain-Barr syndrome (GBS), and any adverse events that were suspected of being associated with vaccines in general or the 2009-H1N1 vaccine.

Over the past eleven years, Dr. Sejvar has been deployed to regions of the United States to track the West Nile virus outbreak (2012), to remote villages in central Africa to investigate the Ebola outbreak (2014), to South America to track the Zika pandemic (2016), among numerous other urgent infectious disease epidemics.

I have worked with a number of worrisome viral outbreaks over the years, but none have frightened me as much as COVID-19 from the standpoint of spread of the disease, apparent ease of transmission, and associated morbidity and mortality, Dr. Sejvar told Neurology Today.

We reached Dr. Sejvar, who has been working 19-hour days, after his return from an extended trip to Rhode Island to engage in a special study examining the risk of contracting the 2019 novel coronavirus after exposure. Back in Atlanta on a mandated 14-day quarantine, he shared his current knowledge and advice on COVID-19.

We are continuously understanding more and more but there is still a lot we do not know: First, how long is someone contagious, and second, how easy it is to spread. We do know that people of older age and those with underlying conditions are at highest risk. People who have impairments that cause difficulty in clearing secretions such as those with Parkinson's disease, severe multiple sclerosis, GBS, or other chronic neuropathies are among those at higher risk. We are also concerned about people with seizure disorders. Although there is nothing specific about their condition that places them at risk, we know that seizures can be triggered in the setting of a febrile illness.

People with those conditions or of older age groups, as well as those taking immunosuppressants or immune-modulating medications, should adhere to the CDC guidelines and HHS advisories to minimize contact with others, both asymptomatic individuals and those who are symptomatic. They need to take these messages to heart.

While most neurologists are not currently on the front lines of directly working with COVID-19, they are clearly seeing people with neurologic diseases associated with aging, such as Alzheimer's disease and Parkinson's disease. Clinicians need to be fastidious in terms of infection control and whenever possible, place symptomatic patients in face masks and make sure that contact is limited. If a patient has known respiratory symptoms, neurologists should try to use full protective personal equipment (PPE) before examination to minimize exposure.

Admittedly, we are in the midst of a very difficult situation in terms of PPE. Quite frankly, there are health departments without adequate PPE. If possible, limit the exposure of someone with respiratory illness or signs of COVID-19 and keep them isolated. The government has worked with industry to ramp up the manufacturing of N95 masks, surgical masks, gowns, and eye shields. In lieu of masks, some people are using bandanas on both the physician and the patient to try to minimize the transmission of respiratory droplets. We know this is not ideal, but the CDC says that it's better than nothing.

In Rhode Island, we have set up tents that cars can go through and people can get swabbed after a brief history of present illness and past medical history is attained. The provider is outside the car and the patient is inside the car. This is being replicated in Massachusetts, New York, and other places. It's possible that a neurologist may be able to test someone and get an accurate assessment while minimizing exposure in waiting rooms and reception areas, by setting up systems that minimize patient contact.

There is a serologic test that the CDC developed for people who had been infected. In January, a group of students from a school in Rhode Island visited Italy, France and Germany before returning home. A teacher came down with COVID-19 and the students were all exposed. We are now conducting a sero-survey to look at how many kids exposed are sero-positive. The serology test is not yet Clinical Laboratory Improvement Amendments (CLIA)-approved and it still needs to be validated with positive- and negative-predictive value. We also don't know whether mounting an antibody response in IgG and IgM confers protection as it does with other viruses. As this is a new virus, we cannot assume that getting ill and recovering provides absolute protection.

One of the most alarming concerns is that COVID-19 transmission in the hospital is orders of magnitude higher than in the community. My biggest fear is that we incur a situation in which we end up with a limited availability of ventilators for people who are elderly or have underlying medical conditions. While the overall fatality rate is about 0.8-1 percent, recent age-stratified data suggests a rate of 9.5 percent for those over the age of 70 years. I am also very worried about the attitude of some young people we are seeing on the news who are ignoring warnings, congregating on beaches and in bars on spring break. Although there are fewer cases, we are definitely seeing people under the age of 45 with pneumonia.

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COVID-19: Advice from CDC Neurovirologist and... : Neurology Today - LWW Journals

Neurologists Scramble to Respond to COVID-19 with… : Neurology Today – LWW Journals

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Article In Brief

In response to COVID-19, many academic and private-practice neurologists have turned to telemedicine. They discuss what works and what has been challenging.

Neurologists in academic and private practice alike are scrambling to embrace telemedicine as one part of their response to the COVID-19 pandemic.

While heartened by the Trump administration's announcement on March 17 that it is lifting many telemedicine restrictions, both on reimbursement and HIPAA compliance, neurologists nevertheless expressed anxiety and some confusion over how to handle the new realityand how long it will last.

We're trying to figure out how to avoid the chaos, stay on solid ground, and feel comfortable knowing everything will be all right eventually, said Brad C. Klein, MD, FAAN, a headache specialist at Abington Neurological Associates in Pennsylvania.

In private practice with nine fellow neurologists and privileges at nearby Abington Hospital, Dr. Klein said his group held an urgent meeting on the evening of March 15 to develop a response to the fast-evolving situation.

Even at a major academic neurology center with an established telemedicine program, efforts to protect physicians, staff, and patients are daunting.

We are feeling our way, said Neil A. Busis, MD, FAAN, who arrived on March 1 at New York University Langone Health to lead its telemedicine program for the department of neurology. Things are moving rapidly. NYU already has had a very robust virtual health program. Neurology has some pilot programs; it's my charge to develop a broader range of options. As you can imagine, right now we're overwhelmed.

Even so, telemedicine evangelists who have been preaching the benefits of digital communication for years say that neurologists will like the new normal, once they get used to it.

I see almost all my patients over the internet, said Ray Dorsey, MD, MBA, the David M. Levy professor of neurology and director of the Center for Health Technology at the University of Rochester Medical Center in Rochester, NY.

I haven't set foot in the clinic in six years. In general we shouldn't make patients come to the clinicians; we should bring care to them. Why do we ask people with compromised driving ability and mobility to come to us? It's crazy. You will learn a whole lot more about your patients and form a deeper relationship with them.

For those not already running a telemedicine program, however, the challenges of building a program on the fly, in the face of a pandemic, are not trivial. But experts hope that an announcement by the White House would ease some restrictions.

In a White House press briefing on March 17, President Donald J. Trump announced that Medicare patients can now visit any doctor by phone or videoconference at no additional cost, including with commonly used services like Facetime and Skype.

No longer will telemedicine benefits be restricted to Medicare patients in rural areas without access to physicians nearby.

Seema Verma, administrator of the Centers for Medicare and Medicaid Services (CMS), said at the news conference: Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home. And these services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.

Alex Azar, Secretary of Health and Human Services, issued a press release stating that the administration will essentially stop enforcing elements of HIPAA that required physicians to use only secure telecommunication services when communicating with patients. For the time being, at any rate, physicians can use (and bill Medicare for) ordinary telephone and video links such as Skype and Zoom.

States are also taking action to speed access to medical care in the era of social distancing. On March 14, both New York Governor Andrew M. Cuomo and Colorado Governor Jared Polis announced that insurance companies in their states must waive co-pays for telehealth visits. The next day, Massachusetts Governor Charlie Baker announced emergency actions to address COVID-19, including ordering all commercial insurers...to cover medically necessary telehealth services in the same manner they cover in-person services.

The moves come as patients around the nation are overwhelming telemedicine services, producing technical and procedural backlogs, Stat News reported.

In response to the changes in how telemedicine visits are being coded and reimbursed, the AAN has established a small working group of experts to develop a new guidance document for members, according to Luana Ciccarelli, the Academy's senior manager of reimbursement & coding.

In place for more than 10 years, the Mayo Clinic Connected Care platform is taking on the recent uptick in telemedicine sessions relatively smoothly, according to Bart Demaerschalk, MD, FAAN, professor of neurology at Mayo Clinic's Phoenix campus and director of its telestroke program.

To the degree possible, neurologists and neurology allied health staff are now working from home, said Dr. Demaerschalk. Clinic appointments are being rescheduled whenever feasible to a telemedicine format. We are trying to utilize a wide variety of digital health tools to best serve and protect our patients including portal messages, telephone, eConsults, video telemedicine, and remote patient monitoring. Our acute-care neurology services, including stroke, can use robotic telepresence devices, allowing neurologists to participate in acute-care patient encounters from their home or office.

The robotic devices, he explained, are remotely drivenoften autonomouslyand include auto navigation and obstacle-avoidance capabilities. In addition to offering synchronous audio-video links, they usually employ such peripherals as stethoscopes, otoscopes, and ophthalmoscopes that a neurologist can deploy remotely. Even so, the availability of telemedicine services does not preclude in-person neurology care, Dr. Demaerschalk said.

I've been in the emergency department several times today to treat an acute stroke syndrome, a seizure, and a patient with a brain tumor, he said. We are abiding by the Centers for Disease Control and Prevention [CDC] recommendations. When a patient presents with a neurologic complaint and has passed all the screening evaluations, we follow standard universal precautionsnothing elevated. No routine use of gloves or masks. Mostly we are seeking to reduce the number of people in a given area and the theoretical risk of viral spread from those patients who might be asymptomatic.

In keeping with CDC recommendations, he said, a few staff members, including at least one neurologist, are currently self-quarantined at their homes after returning from domestic or international travel to areas with high numbers of COVID-19 cases.

At the Cleveland Clinic's Mellen Center for Multiple Sclerosis, staff neurologist and medical director Robert J. Fox, MD, FAAN, said they are taking their response to the outbreak in stride.

First and foremost we are encouraging patients to use online visits as much as possible, said Dr. Fox. We are also offering some clinicians at high risk for COVID-19 complications the opportunity to work from home if possible. About three-quarters of our follow-up visits are now being conducted online, which makes working from home possible.

While preparing for the possibility that neurologists who normally practice in the outpatient clinic will be pulled over to the inpatient service if hospitalizations rise due to COVID-19, relatively modest precautions are being taken for now. As at Mayo, the outpatient neurologists are not generally wearing gloves or masks, he said.

But, he said, I haven't shaken hands with a patient in over a week, which is very unnatural for me. We're waving, we're doing virtual high fives, and we're washing our hands a lot.

After developing a telemedicine program at the University of Pittsburgh Medical Center, where he was clinical professor of neurology, Dr. Busis had the misfortune to arrive at NYU Langone at the beginning of March with an ordinary cold.

The last thing I wanted to do on my first day on the job was to flip out patients and be seen as the COVID-19 equivalent of Typhoid Mary, Dr. Busis said. So he did what he recommends patients do: He arranged a virtual care appointment. After signing up for the NYU Langone service, he filled out an online questionnaire and then queued up in the virtual waiting room.

When the provider showed up, I saw her on a split screen on my iPhone, Dr. Busis said. She could see me, and I could see her. After talking, she told me, You have a cold. Wear a mask, wash your hands a lot, and be upfront with your patients. That's what I did. When I saw my first patients, I told them, Don't worry, this is just out of an abundance of caution. My patients accepted it fine.

Now digging into his job of ramping up the medical center's telemedicine program, not only in neurology but systemwide, Dr. Busis said the easiest part is the telemedicine visit.

Setting up the audio and video at both ends is actually fairly easy, he said. The harder part is documentation, coding, billing, how you notify people, and how you integrate the virtual visits into your workflow. You can't just do telemedicine at the end of the day; you need a schedule combining in-person and virtual visits. And of course you still have to figure out some sort of way to get reimbursed for services, especially if this is going to become sustainable over the long-term.

Until the changes announced by President Trump and other officials on March 17, coding for telemedicine visits was tricky, Dr. Busis said. Different insurers used different codes, and CMS had its own set of codes. Now, he said, The reimbursement landscape is rapidly changing and many of the old restrictions are no longer in effect, at least temporarily. This is a welcome development. All of us wonder how long these restrictions will remain lifted and if they will ever be reinstated.

While Dr. Dorsey at the University of Rochester Medical Center has worked in telemedicine for years, the sudden transition to virtual care for other neurologists there has been bumpy.

The move to telephone and video telemedicine work has been a major change for some of our providers, particularly some that are not as tech-savvy, said Adam G. Kelly, MD, FAAN, associate professor of neurology and director of the New York State Primary Stroke Center at Highland Hospital. It's been a big paradigm shift for our clinic staff but they have done an awesome job modifying what they do in a very short time. This was an almost overnight switch on our institution's part.

With waiting rooms extraordinarily quiet because of the shift to telemedicine, Dr. Kelly said some neurologists there have had to self-quarantine after attending a medical conference where they were potentially exposed to the virus.

Fortunately no one has developed symptoms yet, he said. But, he added, We have had scheduling challenges related to the self-quarantining. We have also needed to build in multiple layers of back-up coverage in case providers become ill. We have asked some providers to minimize contact with one another to decrease the odds that a large group will all need to quarantine should one become ill.

Without the infrastructure and experience of a large institution to rely on, neurologists in private practice are facing what some fear could be an existential challenge.

We had one of our telephone operators today tell our office manager that her son is a nurse who might have been exposed to someone with COVID-19, Dr. Klein said. The administrator had to tell her: You're banned, you're not coming back into the office for 14 days.

Unlike academic telemedicine programs that merely need to ramp up to meet the current need for virtual visits, Dr. Klein's practice is facing the prospect of having to transition virtually overnight.

We only last week started a process to understand the nuances of getting telemedicine into our office, he said. We're trying to understand the reimbursement rules, who pays for it, what we do if the insurers don't cover it. We need to find the right vendor and get it up and running.

Politics aside, he and other neurologists said, greater leadership from the federal government, as well as from insurers, would be helpful.

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Neurologists Scramble to Respond to COVID-19 with... : Neurology Today - LWW Journals

Coronavirus Patients First Symptom was Delirium; Neurologists Form Theory that Virus Could Invade the Brain – Science Times

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(Photo : Photo by Robina Weermeijer on Unsplash)

Nicole Hutcherson, daughter of the late Frank M. Carter, who died from COVID-19 a week ago, recounts how her father's symptoms of the disease were not the common ones seen in most people.

Frank Carter, an 82-year-old local of Goodlettsville, Tennessee asserted he was fine despite having nausea and vomiting. Hutcherson said her father thought he was just dehydrated. Being a nurse, she had some supplies ready on hand and attempted to insert an IV line on her father to address his dehydration.

She recalls how her father had no reaction when she inserted the needle in his arm as if he was sedated. This was when Hutcherson noticed something was off with her father's mental state. She thought it was unusual, as her father had shown no prior signs of dementia or any other cognitive diseases in the past.

Hutcherson believes that the delirium she recognized in her father was one of the first signs of his infection of the coronavirus. Carter died within a week of experiencing symptoms.

Also Read: A Quicker Solution to Coronavirus May Be Vaccines That Are 50% Effective, Scientists Claim

There is growing evidence to suggest that COVID-19, can affect not only the lungs but the brain, as well.

Dr. E. Wesley Ely, a professor of medicine and critical care at Vanderbilt University Medical Center, speculates the possibility of coronavirus being capable of invading the brain. Not much is certain about the coronavirus and its connection with the neurological system.

Due to the lack of information about the matter, Ely and colleagues with the Critical Illness, Brain Dysfunction, and Survivorship Center, in partnership with Vanderbilt and the Nashville VA, have launched a study of post-mortem brain tissue to study signs of COVID-19 in the brain.

Funding for the research will be the National Institutes of Health. The team plans to analyze the brains' neurons for damage, measure different brain regions to see if parts have unusually shrunk, and examine the hippocampus, which plays a large role in memory. The first brain donated to the project was Frank M. Carter's.

A recent study of 214 patients in Wuhan, China, found more than 33% had neurologic manifestations of the disease, including stroke and loss of consciousness. Doctors in the United States have noted the same.

Dr. Johanna Fifi, the associate director of the cerebrovascular center at the Mount Sinai Health System in New York, told NBC News that she had five COVID-19 patients under the age of 49, all with strokes resulting from a blockage in one of the major blood vessels which led to the brain.

Two of her patients had what Fifi described as mild coronavirus infections before the stroke. The other three displayed no symptoms at all.

A similar case is that of 40-year-old Jesse Vanderhoof, a nurse with coronavirus, who spent more than a week on a mechanical ventilator in an intensive care unit in a hospital in Idaho. His wife, Emily Vanderhoof, described how her husband's mind 'wasn't right' as he yanked his IV out of his arm and talked in circles about random topics.

Read Also: Tech Company Claims UV LED Could Kill Coronavirus in 30 Seconds in Support to Research by UC Santa Barbara

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Coronavirus Patients First Symptom was Delirium; Neurologists Form Theory that Virus Could Invade the Brain - Science Times

Coronavirus: Patients have suffered strokes and other neurological symptoms, says study – Sky News

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Patients with COVID-19 have suffered strokes and other neurological symptoms, according to the first scientific study to analyse the effects of the disease on the brain.

The study found that neurological effects were seen in just over a third of all cases of hospitalised COVID-19 patients, but affected more than 45% of those with severe infections.

It isn't yet clear if the coronavirus is causing the strokes directly or as a result of the body's inflammatory response, and leading neurologists say more research is needed.

They warn that as well as respiratory symptoms, doctors need to consider potential neurological effects when assessing new patients.

The study was carried out by researchers at Huazhong University in Wuhan, and the Barrow Neurological Institute in Arizona.

The team analysed cases in Wuhan in China, the original epicentre of the outbreak, between 16 January and 19 February - including 214 hospitalised patients whose diagnoses were laboratory-confirmed.

Just over a third of these patients, 78 (36.4%), had neurological symptoms as well as respiratory symptoms.

"Compared with patients with non-severe infection, patients with severe infection were older, had more underlying disorders, especially hypertension, and showed fewer typical symptoms of COVID-19, such as fever and cough," they found.

The study, in the journal JAMA, was published alongside an editorial by leading neurologists which notes the similarity of the coronavirus to SARS - which researchers have shown caused strokes.

However, unlike in SARS patients, the new study found that neurological symptoms could occur very early within the infection.

Some patients presented at hospital without a fever but had neurological issues including losing their taste or smell, as well more significant impacts such as impaired consciousness, headaches and dizziness.

The scientists warn that the disease may infect the "nervous system and skeletal muscle as well as [the] respiratory tract" which could provide healthcare workers with an additional way to diagnose patients.

COVID-19 has "now reached pandemic status and is common all over the world" said the neurologists in their editorial.

"With so many affected patients, we can expect as neurologists to be confronted with these patients commonly in coming months and years."

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Coronavirus: Patients have suffered strokes and other neurological symptoms, says study - Sky News

Researchers Warn of ‘Wave’ of Neurological Illness Caused by the Coronavirus – Gizmodo

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The damaging effects of covid-19 will extend beyond the lungs to our brains and minds, scientists are warning. The viral disease may directly affect the nervous systems of some patients both during and post-infection, and the stress of the pandemic and its economic fallout is likely already leading to spikes in anxiety among the general public.

In a new preprint paper released this week in the journal Brain, Behavior and Immunity, researchers Emily Troyer, Jordan Kohn, and Suzi Hong, all from the University of California San Diego, argue that the world is set to face a crashing wave of neurological and psychological illness caused by covid-19.

Some of these harms can be attributed to the obvious changes that the pandemic has made to our daily lives, even for people not sickened by the coronavirus that causes covid-19. But theres a growing sense among doctors and scientists that the virus itself can directly affect our brain health.

I think we have all recently witnessed a significant shift in our society and economy, which has been associated with distress and fear for everyone, lead author Troyer, a psychiatrist at UCSD, told Gizmodo. We dont want to minimize that, but my colleagues and I were also curious about whether or not individuals who developed covid-19 would experience not only the psychological stress associated with a pandemic, but also other neuropsychiatric symptoms related to the effects of the virus or host immune response on the nervous system.

Past pandemics caused by viral respiratory illnesses such as the flu, Troyer and her co-authors noted, have been closely linked to reported spikes of neurological or psychiatric symptoms such as brain damage, mood changes, or muscular dysfunction. In many cases, these symptoms have happened during someones initial infection; other times, they happen post-infection. And were starting to see the same pattern with covid-19 emerge. Rarely, confirmed covid-19 patients have also had brain swelling, strokes, or seizures, while many more patients have reported a loss of smell or taste, which can be caused by neurological damage.

The authors lay out a few theories for how this is happening. Some evidence has suggested, for instance, that the coronavirus can slip past the blood-brain barrier and infect nerve cells directly. Another theory is that the immune system overshoots its response to the virus, causing systemic damage throughout the body, including to the brain. They also theorize that certain immune cells can become infected, migrate to the brain, and then trigger dangerous inflammation. Another less supported but plausible theory is that the coronavirus damages the gut microbiome, which then affects the brain.

All these explanations could be true to some extent. But even making it through the initial infection relatively healthy may not spare you from neurological problems down the line. Some viral infections, including the flu, are rarely known to trigger later autoimmune disorders that affect the brain and nervous system, which can cause muscle weakness, chronic pain, and even paralysis.

Beyond those concerns, the pandemic is also affecting peoples mental health. Millions have seen covid-19 sicken or kill their family and friends, with many unable to be with their loved ones as they died or attend funerals in person, due to the aggressive measures needed to slow down person-to-person transmission. These same measures have shut down or curtailed non-essential businesses, dramatically changing most peoples daily lives and devastating many financially. In countries like the U.S., with weak worker protections, these lockdowns have led to the highest unemployment rates seen since the Great Depression.

Already, the authors note in their paper, there have been some reports of suicides among people worried about having the illness or catching it. Essential workers, including in health care, are also reporting high levels of stress and burnout related to covid-19, as many struggle with meager pay and risky working conditions that leave them exposed to the virus.

This pandemic is a potential source of direct and vicarious traumatization for everyone, the authors wrote.

Because were still in the early stages of this pandemic, it may take a long time before we can know how commonly these neurological afflictions are happening among covid-19 patients, especially those post-infection. One unanswered question is whether these complications happen more in people infected with the novel coronavirus, called SARS-CoV-2, than they do in people with other cold and flu viruses. But compared to other recent outbreaks of deadly coronaviruses like SARS and MERS, the scale of this coronavirus pandemic is significantly greater, Troyer said.

By raising awareness of these problems now, the authors hope that the medical community keeps a close eye on the brain health of covid-19 patients moving forward.

We also want people to be aware that the nervous system could be involved in COVID-19, so we hope people will talk to their physicians about any emotional, behavioral, cognitive, or sensorimotor symptoms they might have over the course of their recovery, Troyer said. We dont want to cause people more worrywe just want people to know to talk to their healthcare providers about these kinds of symptoms if they arise, and together we will get through this.

If you or someone you know is having a crisis, please call the National Suicide Prevention Lifeline at 800-273-8255 or text the Crisis Text Line at 741-741.

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Researchers Warn of 'Wave' of Neurological Illness Caused by the Coronavirus - Gizmodo

Brain, nervous system affected in 1 in 3 cases of severe Covid-19 – Health24

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A study out of China finds that strokes, altered consciousness and other neurological issues are relatively common in more serious cases of Covid-19.

Looking at 214 cases of severe coronavirus illness treated in Wuhan city during the early phase of the global pandemic, doctors reported that 36.4% of patients displayed neurological symptoms.

Sometimes these symptoms appeared in the relative absence of "typical" symptoms of Covid-19 fever, cough, diarrhoea the team said.

In such cases, doctors should consider coronavirus infection as a potential cause of the problem "to avoid delayed diagnosis or misdiagnosis", said a team led by Dr Bo Hu, a neurologist at Union Hospital in Wuhan.

Hu's team published their findings online in JAMA Neurology.

Absence of typical symptoms

The suspicion that the novel coronavirus could infiltrate and affect the brain and central nervous system is not new. Last month, numerous reports emerged that one key sign of infection was a loss of sense of smell, pointing to the virus somehow affecting nerve pathways.

In the new report, Hu's team tracked outcomes for more than 200 people treated at three hospitals in Wuhan, the original epicenter of the Covid-19 pandemic. Patients all had disease severe enough to warrant hospitalisation, and were treated between 16 January and 19 February. They averaged about 53 years of age.

Looking specifically at symptoms affecting the brain or central nervous system, the team found that these issues became more common as the severity of illness rose. And, in some cases, typical Covid-19 symptoms were absent.

"Some patients without typical symptoms of Covid-19 came to the hospital with only neurological manifestation as their presenting symptoms," the researchers wrote. In some cases, these issues could be life-threatening: there were at least six cases of stroke or brain haemorrhage observed among those studied, Hu's group reported.

Whether or not infection with the coronavirus directly triggered strokes is unclear, the team said, but in severe Covid-19, a "rapid clinical deterioration or worsening could be associated with a neurologic event such as stroke, which would contribute to its high mortality rate."

Other neurological issues were also at play. Many patients arrived at the hospital disoriented or confused, or were dizzy or had headaches or even seizures, the Chinese group said. Impairments in taste or smell were also seen.

More specific neuroimaging needed

Older patients, many of whom had other underlying chronic illnesses, were at highest risk for neurological issues tied to Covid-19, the study found.

Dr Rafael Ortiz is chief of neuro-endovascular surgery at Northwell Health Western Region in New York City and Westchester, New York.

Reading over the new report, he said "these findings could be related to direct involvement of the virus in the brain, brainstem and peripheral nerves." Other symptoms may be due to the stresses put on the body by the illness itself, he added.

The Chinese researchers and Ortiz agreed that this early study may not be the last word on how the new coronavirus affects the brain.

"A prospective, observational study with a larger number of patients that includes more specific neuroimaging and other diagnostic tests is warranted for more conclusive evidence," Ortiz said.

READ | Neurological ailments in some coronavirus patients - what could this mean?

READ | How scientists found the fingerprint behind South Africa's Covid-19 virus

READ | A lack of sleep affects your immune system - here's how quality sleep can help you fight the coronavirus

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Brain, nervous system affected in 1 in 3 cases of severe Covid-19 - Health24

The global rare neurological disease treatment market is expected to reach US$13,830.96 million by 2027 from US$ 7,300.12 million in 2019 – Yahoo…

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NEW YORK, April 15, 2020 /PRNewswire/ --

The global rare neurological disease treatment market is expected to reach US$13,830.96 million by 2027 from US$ 7,300.12 million in 2019. The market is estimated to grow at a CAGR of 8.5% from 2020 to 2027.

Read the full report: https://www.reportlinker.com/p05882129/?utm_source=PRN

Driving factors of the rare neurological disease treatment market are growing prevalence of rare neurological diseases and favorable pipeline drugs and robust research activities for the treatment of rare neurological diseases. However, high treatment cost incurred is likely to show negative impact on market growth during the forecast period.Rapid developments in healthcare and drug discovery are leading to the introduction of new therapeutic solutions for the treatment of rare neurological diseases.Authorities such as World Health Organization, National Institute of Neurological Disorders and Stroke, and National Institutes of Health are taking constructive steps to encourage research activities to find a remedy for rare neurological diseases.

For instance, in August 2019, National Institute of Neurological Disorders and Stroke and National Center for Advancing Translational Sciences invited researchers to conduct study on rare neurological and neuromuscular diseases.In order to cope up with rising prevalence of rare neurological diseases and geriatric population, pharmaceutical companies are actively participating in the development of drugs.For instance, in December 2019, Healx in partnership with Boehringer Ingelheim announced a plan to discover new treatment approaches in the coming years.Additionally, they are planning to discover new therapeutic options for the treatment of fragile X syndrome and Pitt-Hopkins syndrome.

Additionally, in January 2020, Ovid Therapeutics, a well-known player in rare neurological diseases treatment market, announced the enrollment of patients for pivotal Phase 3 NEPTUNE trial associated with Angelman syndrome.The results of this research study are expected in mid-2020.

Such increasing awareness and developments for rare neurological diseases are likely to boost the growth of the market during the forecast period.The global rare neurological disease treatment market is segmented into indication, drug type, distribution channel, and mode of administration.The rare neurological disease treatment market, by indication, is further segmented into narcolepsy, amyotrophic lateral sclerosis, Alzheimer's disease, multiple sclerosis, spinal muscular atrophy (SMA), Duchene muscular dystrophy, and other indication.

Based on drug type, the rare neurological disease treatment market is further segmented into organic compounds and biologics.Based on distribution channel, the market is further segmented into online pharmacies, hospital pharmacies, and retail pharmacies.

The mode of administration segment is classified into oral, injectables.Some of the essential primary and secondary sources included in the report are Food and Drug Administration, World Health Organization (WHO), Center for Drug Evaluation and Research, Canada Foundation of Innovation, European Federation of Pharmaceuticals Industries Associations, and International Trade Administration.

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Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases – Xconomy

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XconomyBoston

The blood-brain barrier protects the functioning of that essential organ, but its also a hurdle to delivering neurological drugs.

Italys Chiesi Group has agreed to pay Guilford, CT-based Bioasis Technologies $3 million up front to use the preclinical firms technology to facilitate the delivery of enzymes across the blood-brain barrier to treat neurological symptoms associated with four lysosomal storage disorders (LSDs). Such diseases are caused by mutations in the genetic instructions for important enzymes that normally help our cells clear out waste. Without those enzymes, toxic materials build up in the bodys cells over time.

Under the agreement Chiesi is responsible for R&D and commercialization costs associated with the programs. Bioasis is eligible for up to $138 more in milestone payments, plus royalties on net sales of any product Chiesi commercializes using its technology. In exchange Chiesi gets the rights to what Bioasis calls its xB3 platform, the technology the company is developing for the delivery of therapeutics across the blood-brain barrier and the treatment of central nervous system disorders.

Bioasis says its xB3 technology uses a process called receptor-mediated transcytosis and a human transport protein, melanotransferrin, to move molecules across the blood-brain-barrier. The company says that in preclinical studies, this method was able to ferry molecules of varying sizes and types into the brain.

Enzyme replacement therapy is used to treat some LSDs, but neurological complications of the disorders remain largely unaffected even when other affected parts of the body respond to the treatment, according to Bioasis CEO Deborah Rathjen.

The unique delivery method of [Bioasiss] xB3 platform has the potential to overcome a significant challenge in the treatment of many neurological disorders, which is the ability to cross the blood-brain barrier, said Giacomo Chiesi, who heads the companys Boston-based rare disease unit Chiesi, which launched in February.

The BioMarin Pharmaceuticals (NASDAQ: BMRN) drug erliponase alfa (Brineura), for example, which was approved in 2017 to treat a group of degenerative neurometabolic disorders caused by an enzyme deficiency, must be administered directly into the brain through a stent.

Chiesi isnt disclosing the specific LSDs it is targeting. Nearly 50 exist, according to the National Organization for Rare Disorders. For most LSDs no or few treatment options exist.

The companies described their new partnership as a strategic alliance focused on rare diseases.

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Neurologists Are Treating Alzheimer’s Disease by Sending Electrical Currents Deep in the Brain – Science Times

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Bill Gates and other philanthropists from the US have granted the Imperial College London and the UK Dementia Research Institute a $1.5 million grant to put to the test their new technology for Alzheimer's disease.

The neurologists chose 24 Alzheimer's disease patients in their early stages to participate in the therapy. Experts have high hopes for this trial after dozens of dementia drugshave failed tests.

(Photo: Wikimedia Commons)PET scan of a human brain with Alzheimer's disease

Neurologists from Imperial College London and the UK Dementia Research Institute received a $1.5 million grant from Bill Gates and other US philanthropists to start treating Alzheimer's diseaseby sending electrical currents deep in the brain.

The technology is called the temporal interference brain stimulation, which will be participated by 24 patients with early-stage Alzheimer's disease. Electrodes will be attached to their scalp during the trial that will last for two weeks with daily hour-long sessions.

The electrodes will be sending two harmless-high-frequency electric currents, 2,000 Hz and 2,005 Hz, into the brain. When these two slightly different frequencies meet, they create a third current that is a low-frequency wave of 5 Hz.

Neurologists are hoping that this third electric current will make a difference in the treatment of dementia. The frequency will be triggered in an area deep in the brain responsible for new memories, called the hippocampus.

Hopefully, the process would revive the mitochondria in that area of the brain. Mitochondriais the powerhouse of a cell that becomes damaged when a person has Alzheimer's disease.

Unlike the two original beams, the third frequency is not too high a frequency to interfere with the healthy brain tissue. It will only have a similar rate at which the brain cells fire that allows them to spark the affected neurons back to life.

The researchers also tested their new technology on healthy patients. They found an increased blood flow in the brain and improved facial-recognition results.

But it will be the first time to test the new technology on patients with Alzheimer's disease that is scheduled in January next year.

Read Also: No to Dementia: Drink Red Wine, Eat Dark Chocolates and Other Flavonoid-Rich Foods

The new technology which aims to treat Alzheimer's disease will target the mitochondria that are damaged by the disease. According to researcher Dr. Nir Grossman, more and more evidence has come to light that mitochondrial dysfunction has a vital role in the progression of Alzheimer's disease.

He added that this is an essential milestone in their research after years of studying and working on breakthrough technology.

An estimated 850,000 people in the United Kingdom have dementia, and among these numbers around 500,000 have Alzheimer's disease.

Bill Gates, Mikey Hoag, and the US Alzheimer's Association have given 16 grants to different institutions including this new trial, with a total of $60 million as part of their Cloud Program.

Gates said that finding a treatment for dementia needs increased and continued research after witnessing first-hand what dementia could do to people.

Read More: Living Alone in Your 50s and 60s? Dementia Found to Be 30% More Likely: Study

Check out more news and information on Alzheimer's Disease in Science Times.

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Patients With MS More Ready to Use Telemedicine Than Their Neurologists – Neurology Advisor

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The following article is part of conference coverage from the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event. Neurology Advisors staff will be reporting breaking news associated with research conducted by leading experts in neurology. .

While both recognize the importance of a telemedicine approach, patients with multiple sclerosis (MS) appear more prepared and ready to use telemedicine than their physicians during the coronavirus disease 2019 (COVID-19) pandemic, according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event, held September 11-13, 2020.

During the COVID-19 era, patients and clinicians alike increased their use of telemedicine platforms, particularly for routine evaluations that do not require in-person office visits. Study researchers sought to understand the acceptability and satisfaction of telemedicine among patients with MS and the neurologists who care for them.

This study consisted of a brief survey which was administered to a group of patients with multiple sclerosis and their neurologists at an MS center of a hospital in Milan, Italy. 151 patients completed the survey. Approximately 75% of the patient cohort consisted of women. The mean age of participants was 42.2 years, and the median Expanded Disability Status Scale was 1.5. Treatments included interferon (10%), glatiramer acetate (10%), teriflunomide (14%), dimethylfumarate (22%), fingolimod (23%), cladribine (3%), alemtuzumab (8%), and ocrelizumab (10%).

87% of patients said that they appreciated telemedicine during the COVID-19 pandemic. Contrastingly, responses from 82% supported traditional in-office evaluations and their importance in clinical care. Less than half (44%) of participants said that they would alternate in-person and remote telemedicine visits, whereas 38% strongly preferred traditional evaluations. About 10% held a positive opinion of telemedicine but required traditional evaluations. Only 3% of respondents were not satisfied with telemedicine.

The primary reasons given for the strong preference toward in-person evaluations included the need for human empathy with the neurologist, as well as the belief that in-person examinations would lead to better clinical outcomes. Only 18% of respondents said that they would always use telemedicine except if an acute event occurred.

None of the 18 neurologists and residents surveyed said that they would use telemedicine as their only tool for evaluating patients. One-third (33%) of clinicians said that they would alternate telemedicine visits with traditional evaluations, whereas 67% said they would use remote visits only in special situations.

Visit Neurology Advisors conference section for continuous coverage from the ACTRIMS/ECTRIMS MSVirtual2020 Forum.

Reference

Moiola L, Cristinzi MD, Guerrieri S, et al. Telemedicine in/outside the pandemic: a survey about satisfaction of this tool in a cohort of multiple sclerosis patients and their neurologists. Presented at: 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event; September 11-13, 20120. Abstract P0666.

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Patients With MS More Ready to Use Telemedicine Than Their Neurologists - Neurology Advisor

Alaska Neurology Center LLC and Its Owner to Pay $2 Million to Settle False Claims Act Allegations Regarding Fraudulent Medical Billing – Alaska…

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Anchorage, Alaska U.S. Attorney Bryan Schroder announced Freiday that Anchorage-based Alaska Neurology Center LLC and its owner, Franklin Ellenson, M.D., have agreed to pay $2 million to resolve False Claims Act allegations that the medical practice knowingly submitted false billing claims to federal healthcare programs. Contemporaneous with the civil settlement, Alaska Neurology Center LLC and Dr. Ellenson agreed to a three-year Integrity Agreement with the U.S. Department of Health and Human Services.

Healthcare providers who submit false bills hurt honest providers and the nations taxpayers, said U.S. Attorney Schroder. I commend the collaborative efforts of our federal partners to use all available remedies, both civil and criminal, to address waste and abuse in the healthcare market. I am particularly pleased that the public healthcare programs will be made whole, which will help ensure their continued vitality for future generations.

The settlement resolves allegations that, from March 2013 through June 2018, Alaska Neurology Center LLC engaged in multiple fraudulent billing schemes, including: (1)submitting claims with false dates of service in order to obtain reimbursement beyond program caps, (2)submitting claims for infusion services provided by an unqualified medical assistant, (3)submitting claims for physical therapy when the service provided was non-reimbursable massage therapy, (4)submitting claims using multiple, unbundled billing codes, rather than a single required billing code, to obtain overpayment for the service, (5)submitting claims with false names of performing and/or referring medical providers, and (6)re-submitting claims with false service or diagnosis information, and without consulting a medical provider, after an original claim was rejected.

The allegations stem from a lawsuit filed under the whistleblower, orqui tam, provision of the False Claims Act, which allows private parties to bring suit on behalf of the government and to share in any recovery. The whistleblower will receive approximately $380,000 of the settlement.

The governments pursuit of this matter illustrates the governments emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the U.S. Department of Health and Human Services at 1-800-HHS-TIPS (800-447-8477) orhttps://oig.hhs.gov/fraud/report-fraud.

The settlement was the result of an investigation conducted by the Civil Division of the U.S. Attorneys Office for the District of Alaska, in conjunction with the U.S. Department of Health and Human Services Office of Inspector General. Investigative support was also provided by the Defense Health Agency, U.S. Office of Personnel Management, U.S. Department of Veterans Affairs, and the Federal Bureau of Investigation.

The claims resolved by this settlement are allegations only, and there has been no determination of liability. The lawsuit is captionedUnited States of America ex rel. Thomas Fidler v. Alaska Neurology Clinic, LLC [sic], et al., No. 3:18-cv-00057-HRH (D. Alaska).

Source:DOJ

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Neurovascular Interventional Neurology Market 2020: Challenges, Growth, Types, Applications, Revenue, Insights, Growth Analysis, Competitive…

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The Global Neurovascular Interventional Neurology Market is segmented on the lines of its technology, product and regional. Based on technology segmentation it covers embolization & coiling, up porting techniques, carotid artery angioplasty & stenting and neurothrombectomy. Under product segmentation it covers cerebral balloon angioplasty & stenting systems, support devices, aneurysm coiling & embolization devices and neurothrombectomy devices. The Global Neurovascular Interventional Neurology Market on geographic segmentation covers various regions such as North America, Europe, Asia Pacific, Latin America, Middle East and Africa. Each geography market is further segmented to provide market revenue for select countries such as the U.S., Canada, U.K. Germany, China, Japan, India, Brazil, and GCC countries.

FYI, You will get latest updated report as per the COVID-19 Impact on this industry. Our updated reports will now feature detailed analysis that will help you make critical decisions.

Browse Full Report: https://www.marketresearchengine.com/reportdetails/neurovascular-interventional-neurology-market

The Global Neurovascular Interventional Neurology Market is expected to exceed more than US$ 3.0 Billion by 2024 and will grow at a CAGR of more than 8% in the given forecast period.

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the report include Stryker Corporation (U.S.), Medtronic, plc (U.S.), Johnson & Johnson (U.S.), Terumo Corporation (Japan), and Penumbra, Inc. (U.S.). Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

The scope of the report includes a detailed study of global and regional markets for Global Neurovascular Interventional Neurology Market with the reasons given for variations in the growth of the industry in certain regions.

Interventional neuroradiology gives minimally invasive treatments for lesions of the head, neck, spine, brain, and spinal twine. Endovascular treatment options include embolotherapy, the aim of that is the occlusion of extraordinary blood vessels such as vascular malformations, aneurysms, and vascular tumors. And cerebral revascularization, the goal of that is to reopen occluded or narrowed normal vessels. Nonvascular interventions encompass ache management, percutaneous biopsies, percutaneous vertebral augmentation processes, and percutaneous management of disk disorder.

The Global Neurovascular Interventional Neurology Market has been segmented as below:

The Global Neurovascular Interventional Neurology Market is Segmented on the lines of Technology Analysis, Product Analysis and Regional Analysis. By Technology Analysis this market is segmented on the basis of Embolization & coiling, Supporting techniques, Carotid artery angioplasty & stenting, and Neurothrombectomy.

By Product Analysis this market is segmented on the basis of Cerebral balloon angioplasty & stenting systems, Support devices, Aneurysm coiling & embolization devices and Neurothrombectomy devices. By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

The major driving factors of Global Neurovascular Interventional Neurology Market are as follows:

Increasing target patient population Technical advancements in the area of interventional neurosurgeries Increasing healthcare infrastructure in developing nations

The restraining factors of Global Neurovascular Interventional Neurology Market are as follows:

Ongoing healthcare developments in the U.S. Lack of skilled neurosurgeons

This report provides:

1) An overview of the global market for neurovascular interventional neurology and related technologies.2) Analyses of global market trends, with data from 2015, estimates for 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2024.3) Identifications of new market opportunities and targeted promotional plans for neurovascular interventional neurology.4) Discussion of research and development, and the demand for new products and new applications.5) Comprehensive company profiles of major players in the industry.

Request Sample Report from here: https://www.marketresearchengine.com/reportdetails/neurovascular-interventional-neurology-market

Table of Contents

1 INTRODUCTION

2 Research Methodology

2 Research Methodology

4 Premium Insights

5 Market Overview

6 Industry Insights

7 Neurovascular Devices/Interventional Neurology Market, By Product

8 Global Neurovascular Devices/Interventional Neurology Market, By Disease Pathology

9 Neurovascular Devices/Interventional Neurology Market, By Region

10 Competitive Landscape

11 Company Profiles

11.1 Introduction

11.1.1 Geographic Benchmarking

11.2 Stryker Corporation

11.3 Medtronic PLC

11.4 Johnson & Johnson

11.5 Terumo Corporation

11.6 Penumbra, Inc.

11.7 Boston Scientific Corporation

11.8 Microport Scientific Corporation

11.9 Merit Medical Systems, Inc.

11.10 W.L. Gore & Associates, Inc.

11.11 Abbott Laboratories

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Air Pollution May Be Linked to Cognitive Decline in Older… : Neurology Today – LWW Journals

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By Eve Bender May 21, 2020

Research suggests that air pollution, particularly nitrogen dioxide, may be associated with memory loss, cognitive deficits, and a faster rate of cognitive decline among the elderly.

Air pollution in the form of nitrogen dioxide and particulate matter may be linked to deficits in cognition and memory, as well as a steeper rate of cognitive decline in older populations, according to new findings published in the April 8 online issue of Neurology.

Lead author Erin Kulick, PhD, and colleagues analyzed data from two community samples of people living in the Northern Manhattan area of New York City who were enrolled in two larger long-term studies: 5330 people with an average age of 75 were enrolled in the Washington Heights-Inwood Community Aging Project (WHICAP); and 1093 people with an average age of 70 were enrolled in the Northern Manhattan Study (NOMAS). Dr. Kulick is a postdoctoral research fellow at Brown University School of Public Health.

The researchers analyzed data from WHICAP participants at baseline and at six time points collected every 18 to 24 months thereafter. In the NOMAS sample, they analyzed data from baseline and at the five-year follow-up point. Both groups were ethnically and racially diverse with black, white and Hispanic participants.

They also measured air pollution in the form of nitrogen dioxide (N02; parts per billion), fine particulate matter less than 2.5 m in diameter (PM 2.5; g/m3), and respirable particulate matter (PM 10; g/m3) linked to participants' residential addresses.

Dr. Kulick and her colleagues found that WHICAP participants were exposed to a yearly average of 32 parts per billion of N02, 13 micrograms per cubic meter (g/m3) of fine particulate matter and 21 g/m3 of respirable particulate matter. The U.S. Environmental Protection Agency (EPA) considers up to 53 parts per billion to be a safe level of yearly average exposure to nitrogen dioxide, up to 12 g/m3 for fine particulate matter and up to 50 g/m3 for respirable particulate matter.

The team found that among 5330 participants in WHICAP, participants living in areas with higher concentrations of these pollutants, especially nitrogen dioxide and fine particulate matter, performed worse on several measures of cognition and experienced more rapid cognitive decline: a 1 IQR increase in nitrogen dioxide was associated with a 0.22 SD lower global cognitive score at enrollment (95% confidence interval [CI], 0.30, 0.14) and 0.06 SD (95% CI, 0.08, 0.04) more rapid decline in cognitive scores between visits.

Results were similar for fine and respirable particulate matter and across functional cognitive domains. However, the researchers found no evidence of an association between pollution and cognitive impairment in the smaller NOMAS sample.

For those in the WHICAP sample, the association between nitrogen dioxide and the accelerated rate of cognition decline was comparable to approximately one year of aging. With the global prevalence of dementia expected to reach almost 90 million individuals within the next 20 years, even a small reduction in ambient air pollution could have a substantial effect on cognitive health, the authors wrote.

We saw that air pollution levels didn't differ much across the two cohorts, Dr. Kulick told Neurology Today. They are located in the same area within Northern Manhattan in New York City. We thought that these differences might be due to some differences in characteristics of the two cohorts, including stringent selection characteristics into the NOMAS cohort, selecting out individuals with dementia, prior stroke, and any cardiovascular events which may have biased the results.

In addition, she noted, the NOMAS cohort only had two follow-ups over a five- year time period in contrast to WHICAP with up to six visits over more than a decade of follow-up.

There are several biological mechanisms through which we believe air pollution impacts the brain, with the strongest evidence surrounding pathways of systematic inflammation and oxidative stress, Dr. Kulick said. Both have been investigated in a series of animal studies, and it's likely that they are working in concert with each other to cause damage to the brain leading to cognitive decline.

The authors reported several study limitations: Many of the processes leading to cognitive decline begin much earlier in life, and risk factors at midlife are more important for the process of accelerated cognitive decline. In addition, the study only measured pollution levels at participants' home addresses, while participants could have been exposed to varying degrees of pollution elsewhere. In addition, there may have been selection bias in the samples.

On an editorial accompanying the article, author Jennifer Weuve, MPH, ScD noted that that levels of nitrogen dioxide measured near the WHICAP participant homes fell below the US regulatory annual standard of 53 parts per billion. While noting that these measured exposure levels could be representative of higher levels from an earlier period, adverse associations observed at subregulatory standard levels raises questions about whether those standards are sufficiently low to protect population health.

Dr. Kulick said she is currently examining the impact of air pollution on dementia incidence to be able to look at whether air pollution has a clinically important impact on cognitive function. I'm also looking at this question in some national datasets to see if variation in air pollution levels across the country clarify these associations, she said.

While no study can definitely state that air pollution negatively impacts cognitive performance, this study surely adds to the evidence that there is a link, Andrew Petkus, PhD, assistant professor in the department of neurology at the University of Southern California, told Neurology Today.

Dr. Petkus said he'd like to see more research conducted to examine factors contributing to the variability in the association between pollution and cognitive decline.

There have been mixed findings in this association with some studies finding a link between exposure to air pollution while other studies fail to find an association. The current study also produces mixed findings as they find a significant association in the larger WHICAP cohort but not in the NOMAS cohort. This could be due to methodological differences including how the samples were drawn, variability in the amount of air pollution they were exposed to, and differing number of follow-up visit, he said. Identifying factors that may minimize or increase the adverse association between exposure to air pollution and cognitive performance is important to help identify individuals who are at greatest risk. Identifying these moderating factors may also serve as targets for intervention to promote good cognitive health during aging.

Dr. Petkus said that he believes that it is important for neurologists to look for environmental factors that can impact cognition in older adult patients. While exposure to air pollution is a factor that individuals have little personal control over, he said, people can do certain things to ameliorate the risk, such as maintaining a health diet, managing stress, and managing risk factors for cardiovascular and cerebrovascular disease.

This paper provides additional evidence that chronic exposure to air pollution...potentially increases the risk for accelerated cognitive decline in elderly, said Masashi Kitazawa, PhD., associate professor in the Center for Occupational and Environmental Health at the University of California, Irvine. She speculated that the lack of the association between cognitive decline and air pollution could have been due to smaller cohort size, fewer assessments, or other covariants that they did not include such as genetic risk.

We should be aware that air pollution can be an evolving environmental risk for dementia and Alzheimer's disease. These findings will encourage more research to elucidate cellular and molecular basis of air pollution-mediated neurotoxicity linking to Alzheimer's disease, she said.

Drs. Kulik, Petkus, and Kitazawa had no disclosures.

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Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple…

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Basel, May 27, 2020 Novartis announced today that new ofatumumab data from the Phase III ASCLEPIOS trials and the Phase II APLIOS trial were presented virtually at the 6th Congress of the European Academy of Neurology (EAN). The data continue to demonstrate ofatumumab (OMB157) as a potential novel treatment option for patients with RMS. The safety profile was comparable to teriflunomide2.

Ofatumumab is a targeted B-cell therapy that, if approved, addresses a clinical unmet need as the first B-cell therapy that can be self-administered at home through an autoinjector pen2. In addition to being presented virtually, the data were also published in the European Journal of Neurology, Volume 27, Supplement 1, May 2020.

A post hoc analysis from the Phase III ASCLEPIOS I and II trials (n=1882) assessed the odds of patients achieving NEDA-3 with ofatumumab versus teriflunomide within the first (Month 012) and second year (Month 1224) of treatment1. NEDA-3 is a comprehensive composite measure commonly used to assess treatment outcomes in patients with RMS. It is defined as an absence of three measures of disease activity: relapses; disease progression, measured as 6-month confirmed disability worsening (CDW), and gadolinium enhancing (Gd+) T1 lesions3. The study results showed that compared with teriflunomide, a greater proportion of patients treated with ofatumumab achieved NEDA-3 in year 1 (47.0% vs 24.5%; P<.001) and in year 2 (87.8% vs 48.2%; P<.001)1.

Achieving no evidence of disease activity is widely recognized as an important treatment goal for multiple sclerosis therapies, said Professor Ludwig Kappos, University Hospital Basel. These data suggest that halting new disease activity is possible by targeted B-cell therapy in RMS.

A separate analysis from the APLIOS trial (n=284) showed ofatumumab treatment led to rapid and sustained depletion of both CD20+B- and T-cells in patients with RMS. Ofatumumab depleted different B- and T-cell subsets including memory B-cells and nave B-cells, as well as a subset of T-cells that are known to exhibit an activated phenotype. However, CD3+T-cells that do not express the CD20 receptor, were largely unaffected4.

These results are encouraging and support our belief that, if approved, ofatumumab could have the potential to significantly improve the lives of people with RMS, said Krishnan Ramanathan, Neuroscience Global Program Head at Novartis. These data are a testament to our commitment to reimagining medicine and advancing innovative treatments that help people with this serious and progressive disease.

Regulatory action for ofatumumab in the US is expected in June 2020. Novartis is committed to bringing ofatumumab to patients around the world, and additional regulatory filings are currently under way.

About ofatumumabOfatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-adminstered by a once-monthly injection, delivered subcutaneously2,5. As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion6. The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and may preserve the B-cells in the spleen, as shown in preclinical studies7. Once-monthly dosing of ofatumumab also allows fast repletion of B-cells and offers more flexibility8. Ofatumumab was originated by Genmab and licensed to GlaxoSmithKline; Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 20159.

About ASCLEPIOS I and II studiesThe ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase III studies evaluating the safety and efficacy of ofatumumab 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with RMS. The ASCLEPIOS I and II studies enrolled 1882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.52. The studies were conducted in over 350 sites in 37 countries10. Ofatumumab demonstrated a significant reduction in annualized relapse rate (ARR) by 50.5% (0.11 vs 0.22) and 58.5% (0.10 vs 0.25) compared with teriflunomide (P<.001 in both studies) in ASCLEPIOS I and II respectively (primary endpoint). Ofatumumab showed significant reduction of both Gd+T1 lesions and new or enlarging T2 lesions. It significantly reduced the mean number of both Gd+T1 lesions (97.5% and 93.8% relative reduction in ASCLEPIOS I and II, respectively, both P<.001) and new or enlarging T2 lesions (82.0% and 84.5% relative reduction in ASCLEPIOS I and II, respectively, (both P<.001).

Ofatumumab also showed a relative risk reduction of 34.4% (P=.002) in 3-month CDW and 32.5% (P=.012) in 6-month CDW compared with teriflunomide in pre-specified meta-analysis, as defined in ASCLEPIOS. Ofatumumab demonstrated that it lowered neurofilament light levels in serum at the first assessment at Month 3 compared with teriflunomide. There was no difference in slope of brain volume change from baseline between treatments. In a measure of 6-month confirmed disability improvement events, a favorable trend was seen but this did not reach significance. The frequency of serious infections and malignancies was similar across both treatment groups, and overall, ofatumumab had a similar safety profile to teriflunomide. Injection-related reactions, injection-site reactions and upper respiratory tract infection were the most commonly observed adverse events across both treatment groups, occurring in 10% of patients2.

A separate post hoc analysis demonstrated ofatumumab may halt new disease activityin RMS patients. It showed the odds of achieving NEDA-3 (no relapses, no MRI lesions, and no disability worsening combined) with ofatumumab versus teriflunomide were >3-fold higher at Month (M) 012 (47.0% vs 24.5% of patients; P<.001) and >8-fold higher at M1224 (87.8% vs 48.2% of patients; P<.001)1. Overall ofatumumab, a fully human antibody targeting CD20+ B-cells, delivered superior efficacy and demonstrated a safety and tolerability profile with infection rates similar to teriflunomide2.

About APLIOS studyThe APLIOS study is a 12-week, open-label, Phase II bioequivalence study to determine the onset of B-cell depletion with ofatumumab subcutaneous monthly injections and the bioequivalence of subcutaneous administration of ofatumumab via a pre-filled syringeas used in ASCLEPIOS I and IIand an autoinjector pen in patients with RMS. Patients were randomized according to injection device and site including the abdomen and the thigh. B-cell depletion was measured nine times over 12 weeks and Gd+ lesion counts were assessed at baseline and at Weeks 4, 8 and 12. Regardless of injection device or site, ofatumumab 20 mg subcutaneous monthly injections resulted in rapid, close to complete and sustained B-cell depletion. The proportion of patients with B-cell concentrations of <10 cells/L was >65% after the first injection by Day 7, 94% by Week 4 and sustained >95% at all following injections. Ofatumumab treatment reduced the mean number of Gd+lesions from baseline (1.5) to 0.8, 0.3 and 0.1 by Weeks 4, 8 and 12, respectively. The proportion of patients free from Gd+ lesions at the corresponding time points were 66.5%, 86.7%, and 94.1%, respectively4,5.

About Multiple Sclerosis MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss11. MS, which affects approximately 2.3 million people worldwide12, is often characterized into three forms: primary progressive MS (PPMS)13, relapsing remitting MS (RRMS), and secondary progressive MS (SPMS), which follows from an initial RRMS course and is characterized by physical and cognitive changes over time, in presence or absence of relapses, leading to a progressive accumulation of neurological disability14. Approximately 85% of patients initially present with relapsing forms of MS12.

Novartis in NeuroscienceNovartis has a strong ongoing commitment to neuroscience and to bringing innovative treatments to patients suffering from neurological conditions where there is a high unmet need. We are committed to supporting patients and physicians in multiple disease areas, including MS, migraine, Alzheimer's disease, Parkinson's disease, epilepsy and attention deficit hyperactivity disorder, and have a promising pipeline in MS, Alzheimer's disease, spinal muscular atrophy and specialty neurology.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more athttps://www.novartis.com.

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References1. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: Analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Eur J Neurol. 2020;27(1):261263.2. Hauser S. Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials. Presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Conference; September 1113, 2019; Stockholm, Sweden.3. MS Trust. NEDA (no evidence of disease activity) [online]. Available from: https://www.mstrust.org.uk/a-z/neda-no-evidence-disease-activity [Last accessed: May 2020].4. Wiendl H, Fox E, Goodyear A, et al. Effect of Subcutaneous Ofatumumab on Lymphocyte Subsets in Patients with RMS: Analysis from the APLIOS Study. Eur J Neurol. 2020;27(1).5. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell Depletion with Subcutaneous Administration of Ofatumumab in Relapsing Multiple Sclerosis: Results from the APLIOS Bioequivalence Study. Presented at Americas Committee for Treatment and Research in Multiple Sclerosis Forum; February 2729, 2020.6. Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presented at ECTRIMS; September 2016; London, UK.7. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presented at ECTRIMS; September 1417, 2016; London, UK.8. Savelieva M, Kahn J, Bagger M, et al. Comparison of the B-Cell Recovery Time Following Discontinuation of Anti-CD20 Therapies. ePoster presented at ECTRIMS; October 2528, 2017; Paris, France.9. GSK press release. GSK completes divestment of rights to ofatumumab for auto-immune indications to Novartis. December 21, 2015. Available from: https://www.gsk.com/en-gb/media/press-releases/gsk-completes-divestment-of-rights-to-ofatumumab-for-auto-immune-indications-to-novartis/ [Last accessed: May 2020].10. Kappos L, Bar-Or A, Comi G, et al. Ofatumumab Versus Teriflunomide in Relapsing Multiple Sclerosis: Baseline Characteristics of Two Pivotal Phase 3 Trials (ASCLEPIOS I and ASCLEPIOS II). Poster presented at ECTRIMS; October 1012, 2018; Berlin, Germany.11. National Multiple Sclerosis Society. Definition of MS. Available from: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS [Last accessed: May 2020].12. Multiple Sclerosis International Federation. Atlas of MS 2013. Mapping Multiple Sclerosis Around the World. Available from: http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf [Last accessed: May 2020].13. MS Society. Types of MS. Available from: https://www.mssociety.org.uk/about-ms/types-of-ms [Last accessed: May 2020].14. National Multiple Sclerosis Society. Secondary Progressive MS (SPMS). Available from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progressive-MS [Last accessed: May 2020].

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Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple...

Neurologists Dust Off Their Stethoscopes, Join COVID Frontlines – dineshr

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Wilkinson recommends that neurologists looking to join multidisciplinary COVID-19 efforts should review the acute patient management and best practices for prescribing palliative care. These are the two main aspects of working on a COVID-19 ward, he said.

Neurologists in northern Italy, the epicenter of the COVID-19 outbreak in Europe, have also left their usual posts to help during the pandemic.

Anna Bersano, MD, PhD, at the cerebrovascular unit at Fondazione Istituto Neurologico Carlo Besta in Milan, toldMedscape Medical Newsthat many of her colleagues have redeployed to teams at other facilities, especially in Bergamo and Brescia.

Other neurologists at biggerhospitals were reallocated to emergency wards or internal medicine wards, she said.

Although Bersano was willing to help out, she contracted the virus at the end of February. I was not redeployed. I was fortunate enough only to have a long fever, muscle pain, and ageusia. Now Im recovering, she said.

Neurosurgeons have also answered the call to help, especially those who find they have more time on their hands because of the large volume of canceled elective surgeries at their institutions.

We are supporting the frontlines as we can, deploying to emergency room and ICU where we can be helpful, Martina Stippler, MD, a neurosurgeon at Beth Israel Deaconess Medical Center, Boston, Massachusetts, toldMedscape Medical News.

Waiting in the Wings

The intensity of COVID-19 outbreaks in different regions varies widely, but neurologists are ready and willing to switch specialties should the local infection rate and caseload spike.

There has definitely been an effect of COVID. While we have not experienced a surge, the hospital has a steady influx of COVID patients, said ShyamPrabhakaran, MD, professor and chair of neurology at the University of Chicago Biological Sciences, Illinois.

Neurologists remain ready to redeploy as needed. Not content to wait, some neurology faculty are volunteering for shifts in the ED to help triage patients for admission, he added.

The ED faces staff shortages in dealing with the increase in patients with ILI [influenza-like illness].

The pandemic has also changed the number of people coming to his institution forstroke

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The Effects of COVID-19 on Stroke Management in Italy – Neurology Advisor

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Duringthe current coronavirus disease (COVID-19) pandemic the primary focus has beenon infected patients and the frontline responders, and this was associated witha reduction of 45% of total admissions to a Stroke Unit in Italy compared tothe same period in 2019, with a higher prevalence of severe stroke atadmission, according to study results published in the Journal of the Neurological Sciences.

Inlight of the changes inflicted by the COVID-19 pandemic, the researchers soughtto explore the effects of the pandemic on stroke management during the firstmonth of Italys lockdown, between March 9 and April 9, 2020.

The retrospective study included all 16 adults (mean age 77 years) hospitalized to the Stroke Unit of the University Medical Hospital of Trieste during the COVID-19 pandemic with symptoms compatible with acute stroke and the researchers compared the clinical features and outcomes of these patients to 29 patients (mean age 78 years) hospitalized to the Stroke Unit in the same period of 2019. All the patients were tested negative to SARS-CoV-2.

Thegroups were similar with regards to demographic characteristics and strokesubtypes. However, the researchers stressed the 45% reduction of totaladmissions, from 29 patients hospitalized in 2019 to 16 patients admittedduring the recent lockdown.

Theprevalence of severe stroke, defined as NIH stroke scale >10 was higher inthe 2020 cohort, compared to those hospitalized in 2019 (50% vs 28%,respectively). In addition, the mean length of hospital stay was shorter in theCOVID-19 era, compared to 2019. The researchers suggest that the more severeclinical presentation and the faster time course to discharge might be thecause for the worse functional outcomes in the recent cohort, despite a similarproportion of treated patient in 2019 and 2020.

Theemergency structured pathway for acute stroke included separated emergencydepartment and Stroke Unit areas, along with extensive and early use of swabs.This approach allowed the medical teams to offer effective and timelyreperfusion treatments to appropriate patients while protect the staff andother inpatients from infection.

Strokeof unknown symptom onset was more common in the 2020 cohort (50% vs 10%) andthe number of patients that were discharged following a complete stroke work-upwas lower, compared to those admitted in 2019 (31% vs 69%, respectively).

Theadopted strategies for stroke management during the COVID-19 emergency havesuggested being effective, while suffering a reduced and delayed reporting ofsymptoms, concluded the researchers.

Reference

Naccarato M, Scali I, Olivo S, et al. Has COVID-19 played an unexpected stroke on the chain of survival? [published online 4 May 2020]. J Neurol Sci. doi: 10.1016/j.jns.2020.116889

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The Role of Precision Medicine in Parkinson Disease – Neurology Advisor

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Precision medicine, also known as personalized or individualized medicine with the tailoring of specific treatments to the right person at the right time, may be a promising therapeutic strategy for Parkinson disease (PD). A review published in the Journal of Neurology summarizes the clinical trials which target genetic forms of PD, the available data on mechanisms of action, challenges related to therapeutic trials, and the benefits of precision medicine.

Precision medicine requires combining data on specific important biomarkers, along with a patients medical history and other health-related factors, to form a targeted prevention and treatment plan. The possible benefits of precision medicine include diagnosing disease at an earlier stage, identifying the optimal treatment option, maintaining patient safety, improving treatment quality and health system efficacy, and moving beyond reactive approaches to preventing damage (ie, protection of neurons to avoid neuronal death).

As the pathophysiology of PD may differ in each patient, precision medicine may play an important role in PD, allowing for tailored treatments which reflect the unique pathophysiology of the disease. Many studies published in the last decade have significantly contributed to the understanding of the genetic architecture of PD. Researchers have identified many Mendelian loci known to cause familial PD, as well as common loci that are mostly associated with a small increase in risk for PD. Interestingly, alterations in the same gene may lead to different variants and mutations with different risk associations for PD.

A better understanding of the pathophysiology allows for precision medicine and the development of treatments based on mechanism of the disease, with the aim of modifying the disease course rather than just targeting symptoms. The researchers present a review of clinical trials which target genetic forms of PD.

Parkinsonism Associated With GBA Mutations

Mutations in the glucocerebrosidase (GBA) gene, a known cause of Gaucher disease, are a common risk for PD and are present in up to 10% of PD patients worldwide. There are >300 mutations in the GBA gene and the clinical presentation of PD may vary from a mild to a more severe form. A high prevalence of these mutations has been documented among Ashkenazi Jews and those from the Netherlands, while these mutations are less common among Norwegian PD patients.

While it is not fully understood how GBA leads to the development of PD, targeted treatments can be directed towards the modulation of gylcosphingolipid turnover and restoration of enzyme function.

Treatment can be directed at preventing substrate accumulation through the modulation of gylcosphingolipid turnover. Positive results from the phase I study MOVES-PD have reported a dose-dependent decrease in cerebrospinal fluid glucosylceramide levels with the use of the glycosylsynthase inhibitor Venglustat; a phase II study is currently ongoing.

Treatment can also be directed at restoration of enzyme function, resulting in an increase in glucocerebrosidase activity, especially in the brain. These options include enzyme-replacement therapy (ERT), gene therapy, or early glucocerebrosidase chaperones:

ERT = while ERT with recombinant glucocerebrosidase is available for Gaucher disease, there are no data available on the use of ERT in PD.

Gene Therapy = gene therapy using adeno-associated virus-mediated expression of glucocerebrosidase had positive results in pre-clinical studies for GBA and Prevail Therapeutics, a new company launched in 2017, is expected to publish the results of a clinical trial in 16 GBA-PD patients.

Early glucocerebrosidase chaperones = several early glucocerebrosidase chaperones were previously investigated. While isofagomine had no significant clinical improvement for patients with Gaucher disease, ambroxol is a promising agent that was shown to improve lysosomal function and increase enzyme activity. Ambroxol is currently being studied in the AiM-PD trial, which includes GBA-positive and GBA-negative PD patients, and may also be relevant to patients with idiopathic PD. LTI-291, an activator of the GCase enzyme, showed a dose-dependent brain penetration in a phase 1b trial that included patients with GBA-PD.

Small molecules can also be used to treat PD by modifying GBA-independent pathways. In oncology cell cultures, RTB101, an inhibitor of target of rapamycin complex 1 (TORC1), reduced the levels of glucosylceramide, the main substrate of GCase. A phase 1b/2a is of RTB101 with sirolimus is currently ongoing and includes PD patients with and without GBA mutations.

LRRK2Associated Parkinsonism

Similar to GBA, mutations in LRRK2 are more common in certain ethnicities and they are the most common cause of autosomal dominant PD. Some point mutations in LRRK2 are causative for PD, while coding polymorphisms in the gene are strong risk factors. Additional higher frequency variants at the LRRK2 locus may contribute to a small increase in the risk for developing PD. The mechanisms by which mutations cause PD are not completely understood, but it appears to result from increased LRRK2 kinase function, supporting the potential benefit of kinase inhibitors.

While there has been improvement in the potency, selectivity and brain penetrance of LRRK2 inhibitors, efficacy and safety remain a concern. Several structurally different LRRK2 inhibitors from Genentech, GSK, Merck and Pfizer are in the pipeline. Biogen is currently recruiting LRRK2 patients into a phase 1 trial to assess a single intrathecal injection of the compound BIIB094, an antisense oligomere.

Major Challenges

Precision medicine trials are more complicated than standard clinical trials, and must overcome several challenges; these include, but are not limited to, the need for a large number of study participants and the need for genotyping a larger proportion of patients with PD. The relative lack of biomarkers that reflect disease progression and response to treatment is another major challenge.

The lead author of this review, Professor Susanne Schneider from the Ludwig Maximilians University in Munich, Germany, is convinced that a new era of research for Parkinson therapy is beginning. She told us that recruitment of studies will take the genetic makeup of patients and their individual clinical phenotype into account. The idea is to have the study cohort as homogenous as possible so that effects can stand out and are not lost in the fog. This may also allow to keep numbers of participants much smaller. Prof Schneider also noted that, stricter inclusion criteria will make recruitment more difficult at the same time, as fewer patients will be eligible.

Notably, patients are more and more involved in early phases of trial planning and patients feel they are part of the process and are thus more willing to participate in trials. These are exciting times! she remarked.

The review authors concluded that advancing precision medicine will further encourage and support the next generation of scientists to develop creative new approaches for detecting, measuring, and analyzing a wide range of biomedical informationincluding molecular, genomic, cellular, clinical, behavioral, physiological, and environmental parameters.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors disclosures.

Reference

Schneider SA, Alcalay RN. Precision medicine in Parkinsons disease: emerging treatments for genetic Parkinsons disease. J Neurol. 2020;267(3):860869. doi:10.1007/s00415-020-09705-7

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Neurologist addresses disrupted sleep patterns – University of Miami

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University of Miami sleep expert Dr. Salim Dib explains the reasons behind our collective issues and offers tips on things we can do to improve our slumber.

Lately, if you find yourself tossing and turning more or waking up from some disturbing dreams, you are not alone.

A growing number of people are reporting worsening sleep difficulty in the wake of the coronavirus outbreak. And, the sleep medicine department at the University of Miami has been fielding calls from existing patients and new ones who are struggling to get some shut eye during the COVID-19 quarantine, said Dr. Salim Dib, a neurologist in the Sleep Center at the Miller School of Medicine.

With the current crisis and its confinement, a lot of us are at risk of being sleep deprived because we lose a lot of the daily routines and structure we used to have, Dib said. Also, the added stress we are underfrom the news, to possibly losing our jobs, as well as having to deal with home obligations, children, and schoolis astronomical, and that alone can affect our sleep timing, duration, and quality.

Stress is a major hindrance to sleep because it triggers humans fight or flight reaction, Dib said. This in turn increases our bodys levels of adrenaline to help us cope and to protect us, but it can also make sleep more elusive.

Thats what is affecting everyone right now, he added. Sleep is a lot worse than it used to be.

Still, sleep is incredibly important to our health and well-being. It affects our blood pressure and organ systems, our mood, our cognitive function, and performance, as well as our physical performance and abilities, Dib said. In addition, it impacts our immune system.

Our ability to defend ourselves from a virus is impaired and our risk for infection can significantly increase if we are not getting enough sleep, Dib pointed out.

There is plenty of research to support this. In a 2002 influenza study published in the Journal of the American Medical Association, Dib said sleep-deprived patients were unable to mount the same antibody response to the influenza vaccine when compared to patients who were able to get seven hours of sleep. Also, in a 2009 study, investigators quarantined 153 healthy adults and exposed them to a common cold. Those who had gotten less than seven hours of sleep were three times more likely to develop a cold compared to those with eight hours or more of sleep.

So how much sleep should we be getting? Dib said that on average, most adults should be getting from seven to nine hours of sleep. He recommended a minimum of 7 to 7.5 hours of sleep. For children, the average varies by age, so Dib suggested consulting the National Sleep Foundation standards.

It is also important to go to bed and wake up around the same time each day to maintain a regular sleep-wake schedule.

Recent studies have showed that an irregular sleep schedule can increase your risk for heart disease, Dib noted.

To get the most out of a nights rest, people need to be able to cycle through the various stages of sleep. These include slow wave sleep, when brain activity slows down and metabolic function is reduced. During this stage, nervous system restoration and memory consolidation occur, and the brain essentially clears itself of waste products. According to Dib, slow wave sleep is also essential for regulating hormones, tissue repair, and re-priming the immune system. Whereas, the rapid eye movement stage of sleep, or REM sleepwhich happens about every 90 to 120 minutesis important for processing emotions, reducing stress, and learning. Thats when we have our most vivid dreams.

We do a lot of emotional processing and we sort through information during REM, which can influence the content of our dreams, Dib said. In fact, any internal or external stressor can affect our dream content and contribute to unpleasant vivid dreams at times.

Although several stressors are clearly affecting us now, there are many things that people can do to improve their own sleep, as well as their childrens, Dib added.

Dib suggested that first, we need to create a sleep-conducive bedtime routine. This should include unwinding in the evening and doing something relaxing in the hour or two before bedtimesuch as meditating, reading, taking a walk, or doing a puzzle or artwork. Taking a warm bath is also a good idea to relax the body and help it transition into sleep.

Next, Dib said, ensure that your bedroom is a haven for sleep. Make sure it is dark, quiet, cool (ideally 60 to 67 degrees) and comfortable. Also, try not to bring work into your bedroom, and try not to use your electronics in bed (including computer, phone, or tablet). Dedicate time in the early evening to do problem solving and planning, away from the bedroom, and write down anything you need to remember for the next day before going into your room for the night.

Stress reduction is crucial before getting into bed, he pointed out. Avoid stressful activities like watching the news and avoid bright light exposure in bed.

Other things to avoid before bedtime:

While people often drink alcohol to calm down, and some even have a nightcap, Dib said it can result in significant sleep disruption and may contribute to unpleasant dreams.

Dib said that physical activity is of utmost importance; but ideally, high intensity exercise should be done in the first half of the day. Along with exposure to bright light in the morning, this can help reset our internal clocks. He recommended 30 minutes of moderate intensity exercise per day, or at least three times a week. This can include aerobic activity, including brisk walks and/or swimming and light weightlifting.

When we overdo it at night, we become more alert and our core body temperature rises, which makes falling asleep more difficult. We need to be able to lower our core body temperature to fall asleep, he said.

Try to eat healthfully and avoid heavy or spicy foods, as well as excessive fluids, in the evening, Dib said. It will help you avoid discomfort and reflux, as well as excessive trips to the toilet, which will disrupt your sleep.

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Neurologist addresses disrupted sleep patterns - University of Miami