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Here’s What I’ve Learned After Looking into Deep Brain Stimulation

deep brain stimulation

Dad’s dyskinesia is worsening at a startling pace. When he doesn’t take his medications, he’s nearly immobile. And when he does, dyskinesia wreaks havoc on him. At a loss for options, we’ve been searching for alternative solutions to assist in the management of his PD symptoms. A procedure called deep brain stimulation (DBS) currently is one of the more effective options for patients in the late stages of PD.

Anyone who struggles with a degenerative disease can attest to the accompanying feelings of desperation. Not knowing what function the disease will steal next is nerve-wracking. Parkinson’s disease is currently incurable, but some options can help manage the disease’s progression. While weighing your options, what thoughts rise to the surface? How might undergoing DBS affect your loved ones? Could the benefits affect quality of life enough to make it worthwhile? And what kind of risks are involved?

What does DBS do?

Used for the first time in 1986, DBS primarily helps with motor symptoms, specifically severe motor fluctuations or tremor in advanced stages, according to one study’s description.

During the procedure, a surgeon places electrodes in the brain. These electrodes transmit impulses that either interrupt or change abnormal brain activity. The wires can be placed in multiple areas of the brain, which impacts the potential effects of the pulse interruptions. For example, Dad struggles most with dyskinesia and hopes to alleviate those symptoms. But if tremors are inhibiting someone, a surgeon can adjust the placement of electrodes to benefit that person’s body optimally.

A surgeon places a device that’s similar to a pacemaker under the skin beneath the collarbone. This piece of hardware transmits signals to the electrodes, allowing them to moderate adverse brain activity. The procedure generally causes minimal or no tissue damage. Ultimately, DBS is not a cure, but it can significantly impact quality of life, according to various studies and anecdotal evidence.

Is everyone a candidate?

Newly diagnosed Parkinson’s patients can’t undergo DBS. One must be a patient for four years before consideration. Ideal candidates have few other options to assist in the management of Parkinson’s symptoms. DBS candidates take medications for PD that sometimes work, but often may involve complications like dyskinesia.

Doctors diagnosed Dad in 2013, so he isn’t a new patient. He’s cognitively, emotionally, and physically strong enough to undergo the procedure. His medication works, but it causes severe dyskinesia. However, when he doesn’t take his medication, he suffers from freezing and increased mobility issues. We’ve reached a point in which Dad’s Parkinson’s symptoms are greatly impacting his quality of life. After seeing many different doctors, they’ve determined that he’d make a good candidate for DBS.

Potential benefits of DBS

According to a 2011 study by the Mayo Clinic, DBS patients often see positive results, including sometimes regaining significant mobility. “Stimulation of the ventralis intermedius nucleus of the thalamus has clearly been shown to markedly improve tremor control in patients with essential tremor and tremor related to Parkinson disease,” the study said. “Symptoms of bradykinesia, tremor, gait disturbance, and rigidity can be significantly improved in patients with Parkinson disease.”

The procedure may decrease the use of medications, although patients should work with their doctors to adjust the device’s impulses to meet each person’s unique needs.

According to a 2019 study published in the Journal of Neurosurgery that addressed long-term outcomes for DBS patients, “Tremor responded best to DBS (72.5% of patients improved), while other motor symptoms remained stable. Ability to conduct activities of daily living (ADLs) remained stable (dressing, 78% of patients; running errands, 52.5% of patients) or worsened (preparing meals, 50% of patients). Patient satisfaction, however, remained high (92.5% happy with DBS, 95% would recommend DBS, and 75% felt it provided symptom control).”

The study also observes that more than half of the Parkinson’s patients who received DBS survived for 10 years or longer. Considering that many individuals undergo DBS when alternative solutions become scant and decline becomes startling, an additional 10 years seems encouraging.

Risks associated with DBS 

Anytime surgery is involved, risk is involved, too. Some serious side effects include brain bleed, stroke, infection, or impacted memory. Also, part of the reason doctors screen potential DBS candidates for dementia and Alzheimer’s disease is to avoid worsening underlying memory problems.

As the Mayo Clinic notes, DBS is a “potentially risky procedure,” and patients should “carefully weigh the risks and potential benefits of the procedure.” Read more about possible side effects here.

Current DBS research

Some researchers are attempting to expand DBS treatment to influence freezing and balance issues. Others want to develop a smart device that sends signals when the body is particularly reactive. Some researchers are determining where and when the placement of the device is most optimal. While the best way to use DBS is still under research, clinical trials are exploring the use of DBS to manage different neurological disorders, giving hope to those who struggle with tremors, gait disturbances, and other motor-related issues. Improving outcomes for those who undergo the procedure seems inevitable, given the current interest.

Should you consider DBS?

Surgery is frightening, regardless of the positive outcome numbers. I’m terrified to think about Dad on the operating table. The decision to undergo surgery is never easy, and everyone’s situation is different. Knowledge is the best weapon against degenerative disease. Weigh the potential good and bad impacts it may have. Ultimately, only your medical team and you can determine whether DBS is a good option for you.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

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APDA Meets to Discuss Grants, Diversity in Parkinson’s Research, Support, and Care

APDA Grant Research

The American Parkinson Disease Association (APDA) recently hosted two groups of experts who assessed scientific projects vying for funding, and addressed diversity issues in Parkinson’s disease research and care.

The organization met with its scientific advisory board (SAB) to decide which grant projects it will fund for the 2019-2020 academic year. Grants are based on overall significance and field impact, appropriateness of the project’s chief investigator and scientific environment, and feasibility of the project’s proposed budget and end date. Funding decisions will be announced in August.

The APDA also hosted its first-ever Diversity in Parkinson’s Research Conference, which focused on needs surrounding the disease in diverse and under-served communities. Attendees included researchers investigating Parkinson’s in ethnic and minority populations, and clinicians who treat such patients.

Panel discussions included an overview of APDA diversity initiatives, research about biomarkers in diverse populations, disparities in Parkinson’s clinical trial enrollment, and what the field of hypertension can teach Parkinson’s investigators about access to diverse communities.

Currently, most Parkinson’s research focuses on relatively older white men, the APDA said. The organization wants to expand investigations to include more patients of varying ages, genders, races and ethnicities. It also wants more access among these groups for care, programs and services.

”APDA’s mission is to help everyone impacted by Parkinson’s disease live life to the fullest, and we mean everyone,” Leslie A. Chambers, APDA president and CEO, said in a press release.

The organization plans to establish an annual grant to support research focused on closing diversity gaps. For now, it offers an annual $50,000 post-doctoral fellowship, and multiple $75,000 research grants. The three-year $300,000 George C. Cotzias Fellowship supports early-career physician-scientists. In addition, the APDA awards its Centers for Advanced Research $100,000 each year to support PD investigations. (Visit this site for more information on APDA-funded research.)

”It’s so exciting to see the fascinating ideas outlined in the grant submissions,” said Rebecca Gilbert, MD, PhD, APDA vice president and chief scientific officer, of the current crop of proposals. “Proposed research projects included everything from ways of detecting a diagnosis of PD in the blood, to exploring ways that telemedicine can improve the lives of patients with PD. The SAB certainly had their work cut out for them and made some tough choices,” she said.

In addition to deciding who gets new grants, the SAB receives updates during annual meetings about previously funded research. During the May 16 meeting, for example, members were apprised of the latest research at the University of Alabama at Birmingham, where scientists are focused on advances in the role of brain inflammation in Parkinson’s development and progression. The SAB also heard from Washington University School of Medicine researchers studying imaging biomarkers for Parkinson’s.

David Standaert, a leading Parkinson’s researcher at the University of Alabama at Birmingham, also is the SAB’s chairman. He called the Diversity in Research Conference a “fantastic” first step toward finding answers.

”Together, I think we can do great things to make both our research and services more inclusive and accessible,” he said.

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Educating the Educated About Parkinson’s Disease

EDUCATING

Sherri Journeying Through

I went to the dermatologist yesterday for a skin check. Those of us who have Parkinson’s disease (PD) should make a habit of getting a yearly check because our condition increases the odds of getting skin cancer. The Mayo Clinic reported that patients with Parkinson’s “were roughly four times likelier to have had a history of melanoma than those without Parkinson’s, and people with melanoma had a fourfold higher risk of developing Parkinson’s. …”

So, I had an appointment with the dermatologist.

After a thorough body check and five biopsies, I was free to leave. The nurse stayed back with me after the doctor left because I struggled to move. She asked when I was diagnosed with Parkinson’s. After I answered “2004,” she replied, “Isn’t that young for Parkinson’s?” Not as young as when the symptoms began 10 years before that, I wanted to answer. 

She followed that question with another: “Did it run in my family?”

No.

“Not even one relative?”

No.

“Are you sure?”

Yes.

While I dressed and walked out to where my husband waited in the car, I shook terribly. That’s something I hadn’t done in quite a while. I was sure it was the combination of numbing five different areas with an intrusive needle and the anxious feeling that came over me with the news that spots could be cancerous. However, what caught me almost more off guard was the nurse’s questioning. 

I guess what surprised me is how uninformed so many still are.

I have spoken to groups about my 20-year journey with Parkinson’s disease. I write about it on my blog. I am open about it with others. I have written articles for several different publications. I am a PD advocate. I know a lot about the disease. I just figure others do, too. What surprised me most about her questions was that she worked for a dermatologist who should be very familiar with PD since the disease can highly affect the skin.

As patients, our job is far from finished.

As long as we live with PD, we are responsible for getting information about this disease out to everyone we can, as best we can. Not just to newbies in the patient club, but also those in the medical fields. Perhaps the patients and caregivers should hold a conference for medical professionals instead of the opposite. After all, we are living PD day to day, feeling it moment by moment. As my movement disability specialist once told me, “You patients are the experts. The doctors take their cue from you.”

If that is true then we need to be proactive with the hand we’re dealt. We must educate those around us, whether they’re a patient, nurse, caregiver, doctor, dental hygienist, or medical transporter. It’s going to take a whole lot more than answering the question of whether Parkinson’s disease is hereditary — it was obvious to me the nurse wasn’t buying my answers.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

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Canadian Groups Launch Large-scale Initiative to Capture Data on Parkinson’s Patients Nationwide

Canadian Parkinson's survey

Parkinson Canada and Brain Canada have recently launched the Canadian Open Parkinson Network (C-OPN), the first platform to include data from people with Parkinson’s disease across the country and facilitate access to researchers studying the disease.

Supported by a $2 million grant, the C-OPN will include a national patient registry along with a database that has extended clinical information — data from diagnosis (including magnetic resonance imaging and positron emission tomography scans), patients’ motor and cognitive parameters, and records of sleep, behavioral, and neuropsychological analysis.

Additionally, the C-OPN will operate as a biobank, or a repository for patients’ biological material — blood samples and DNA — for researcher access.

“The Canadian Open Parkinson Network is a major initiative that will keep Canada at the leading edge of Parkinson’s disease research. By building a strong, interconnected and collaborative network of researchers, physicians and people living with Parkinson’s, we can work strategically to accelerate advancements in Parkinson’s research and treatment,” Oury Monchi, PhD, said in a press release.

Monchi will serve as the director and principal investigator of the C-OPN. He is also the clinical research director at the Hotchkiss Brain Institute, Cumming School of Medicine at the University of Calgary.

“Brain Canada is pleased to be a partner with Parkinson Canada on the Canadian Open Parkinson Network. This program follows the establishment of the Canadian Open Neuroscience Platform, a national effort we initiated to link data across the country, and standardize how we collect, store and analyze this data,” said Inez Jabalpurwala, president and CEO of Brain Canada.

“The Parkinson registry and database will create the first national platform to capture data from those living with Parkinson’s, and make the data accessible to a wider number of researchers. The goal is to accelerate our already excellent Parkinson’s research in Canada, resulting in better patient outcomes,” ‎ Jabalpurwala added.

The C-OPN hopes to build capacity and increase awareness among government, healthcare professionals, researchers, health charities and the general public.

“With more than 25 people diagnosed each day, we are reminded why establishing the Canadian Open Parkinson Network is critical now. It brings hope for a cure, and accelerated treatments over the next ten years and beyond, and it involves the very people whom researchers are trying to help,” said Joyce Gordon, CEO of Parkinson Canada.

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The ABCs of Parkinson’s: ‘K’ Is for Knowledge

knowledge

Sherri Journeying Through

A continuation of the “ABCs of Parkinson’s” series.

When diagnosed with Parkinson’s disease (PD), or any disease, it is always beneficial to educate yourself about it. Ask yourself: Do they know what caused it? What are the symptoms? How can I best care for myself? Is there a cure?

Knowledge is a good and powerful thing. However, too much knowledge can be detrimental to your health.

Upon receiving a Parkinson’s diagnosis, each patient’s reaction will differ from another’s. You may want to know more. You may want to know little or nothing about the disease at first to allow yourself time to adjust or grieve. When you get to the point of wanting to know more about PD, tread carefully and cautiously. While there is a plethora of information out there to soothe those hungry for knowledge, not all sources are created equal.

Look for studies and research carried out by credible institutions and conducted relatively recently. You’ll find articles citing studies published five or more years ago, written as though the research is new. While the information may be still relevant, check if more up-to-date research is available. 

Many publications report on the findings from new studies. Take care not to overwhelm your brain. You don’t have to read all 112 articles on the research; a couple from your favorite publishers will be sufficient unless you are writing a research paper or testing your brain to see how much information it can hold.

Too much knowledge can cause unnecessary anxiety and stress. Parkinson’s is a unique disease for each patient and symptoms, medications, and the effects of treatments can vary from one individual to another.

I’d just finished reading a post on Facebook by a woman who was recently diagnosed with PD and wanted to know what to expect. The very first reply from a disgruntled caregiver who desperately needs a break would have scared the bejeebers out of me if that reply was the first bit of solicited advice I had received.

Go easy on the “knowledge” you give to a newbie. We are here to encourage them on their journey. The last thing they need at the onset of diagnosis is to have the living daylights scared out of them with all of the knowledge we’ve acquired. That wouldn’t be prudent or wise.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

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Arranging for My Brain Donation Was an Arduous Process

brain donation

Why is there no cure for PD?

In my mind, there are several potential reasons there is no cure for Parkinson’s disease (PD). The brain is an extremely complex organ and there is no known definitive cause for the disease. Each PD diagnosis is unique, patients suffer different symptoms and different rates of disease progression, and certain remedies work for some but not for others. Is there any wonder why there is not yet a cure for PD and why nothing currently exists to slow its progression?

How can I help?

I do not believe there will be a cure in my lifetime. However, I want to be able to do what I can to help so that others diagnosed with PD in the future will have some hope. Other than participating in clinical trials and research studies, there is one other option I found that may help those diagnosed with PD in the future. I have arranged to donate my brain for research. Brain donations give researchers the chance to understand PD better. This will facilitate new treatments while also helping to increase the odds of finding a cure.

Please note that brain donation is not considered part of organ donation and must be handled separately.

To donate or not to donate?

I give you fair warning: My experience in researching and processing the paperwork to donate my brain was extremely frustrating. It was also a huge emotional roller coaster, and more than once, I was tempted to give up. It took almost three months from the time I started investigating my options until I received final confirmation that my request will be honored.

I believe we all struggle with accepting our mortality, PD-afflicted or not. I don’t know of anyone who looks forward to planning for their demise and what happens after, especially when it comes to things like organ donation and cremation. What if I need my body and all its parts in the afterlife? This is a thought that crossed my mind many times while I was in a holding pattern waiting for the donation organization to get back to me. Only focusing on my end goal of donating my brain with the intent of helping others kept me from quitting.

The process

After doing a Google search on brain donation, my first stop was the Brain Support Network website.

Question 3.7 of their FAQs indicated the following:

“… New York makes brain donation difficult because state law requires that the brain be procured at a hospital. No New York hospitals are willing to plan in advance for brain donation.”

So, it seems that living in New York adds another layer of complexity when you want to donate your brain.

I found my way to a site that lists the six U.S.-based regional brain banks, one of which was Mount Sinai Hospital in Manhattan. I clicked on their website and finally discovered the right place! There, I found contact info and forms to download.

Unfortunately, getting someone to confirm that my paperwork was received and processed was a long, arduous process. I wanted to ensure that all was taken care of so my loved ones would not be left wondering what my wishes were and how to accomplish them after I die.

My mind was finally put at ease when I received my formal donor card in the mail. Now, I can forget about the dilemma of having a brainless body in the hereafter.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

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Michael J. Fox Foundation Offering $7.5M in Funding for Parkinson’s Research Projects

MJFF research funding

The Michael J. Fox Foundation is continuing to support the advancement of Parkinson’s disease research by investing up to $7.5 million in projects proposed by investigators, the nonprofit recently announced.

Funding will be considered for projects aimed at the following four areas: exploring new biological targets for therapeutic development; identifying biomarkers to objectively measure disease progression; testing potential new treatments; and determining preventive factors.

“Our core goals are to better understand, measure, treat and — most significantly — prevent Parkinson’s disease,” Todd Sherer, PhD, the foundation’s CEO, said in a press release. “We ask scientists to bring us their promising, innovative projects in these areas to move the needle closer to cures and better quality of life for people with this disease today.”

Scientists can submit their proposals through Sept. 26, with funds anticipated in May 2019.

The foundation has divided each of the research areas into four programs for which investigators can apply for grants.

To find new biological targets of the disease, the Target Advancement Program will focus on the identification of proteins and pathways that are involved in the onset and progression of Parkinson’s.

Finding these targets will not only shed light on neurodegeneration and motor and non-motor dysfunction and symptoms, but it will also enable the development of potential new therapies to slow or stop disease progression.

The Improved Biomarkers and Clinical Outcome Measures program is intended to identify biomarkers associated with the disease that can be effectively quantified using objective tests, and accelerate the development of new therapies. These tests are expected to improve diagnosis, track disease progression, and monitor treatment response.

The Therapeutic Pipeline program seeks to develop new therapies that can change the course of the disease and improve treatment beyond the current standards of care. Existing treatments alleviate symptoms, but do not address several aspects of the disease, and can result in serious side effects.

A fourth program is centered on Parkinson’s prevention. By using epidemiological factors, such as lifestyle behaviors (e.g. diet and exercise), medication taken or other types of treatments, the foundation hopes to identify which factors can decrease the risk of Parkinson’s disease.

Each of the four programs will receive a total of $1.5 million of the grant money, with the exception of the Therapeutic Pipeline program, which will receive $3 million to fund preclinical and clinical studies.

Applications for project submissions are now open. Both academic and industry scientists worldwide are invited to apply.

The foundation will host a webinar at 12 p.m. EST Sept. 6 to review the goals of the programs, explain the funding process, and answer applicant questions. For more information and to register for the webinar, visit here.

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Source: Parkinson's News Today

Some Thoughts About Treating Parkinson’s Disease

treated, neuroprotective medications

Sherri Journeying Through

Someone told you that you or someone you love has Parkinson’s disease (PD). You’ve also heard that it is incurable. Nevertheless, can it be treated? If so, what medicines are used?

First, let me say that I was diagnosed with PD over 10 years ago and misdiagnosed with lupus over 20 years ago. As stated earlier, Parkinson’s disease is not curable, but it is treatable, to a degree. Just maybe, the day you’ve reached your “last degree” will be the day they announce a cure.

No one I have ever met likes taking pills, and yet to treat Parkinson’s effectively, there is no way around it for the common patient. Patients must also understand that Parkinson’s disease affects each person differently, so each patient is treated differently and different medications will be used accordingly.

My drug therapy has been conservative, according to my neurologist. For example, one medication at a time is added at the time of my checkup, if needed. This is done so that the physician is able to correctly identify which medication a patient reacts to should side effects occur. This can be a much safer procedure than starting with eight pills, three times a day, and working backward.

Pharmaceutical companies would go out of business if they were not constantly coming up with improvements to the treatments already available on the market. That, in and of itself, says the medical field is making progress in creating treatments for PD and other diseases.

While I said earlier that PD is incurable, it is treatable. Treatable, however, will look different for you than it does for me or another patient. Some will be behind you in their progression of the disease, some ahead. It also depends on how each individual doctor believes or thinks the disease should be best treated. As you can see, many different factors come into play when a physician must come up with a custom treatment that best suits a patient.

Of the medications available that physicians choose for their patients, some of the more tolerated and beneficial seem to be Mirapex (although it is noted to have serious side effects for some), Sinemet, Artane, Requip, and Comtan. Doctors might add other various medications be added to the mix depending on a patient’s symptoms and needs. These could include Azilect, Lexapro or another antidepressant (as one of the first notable symptoms of PD is depression), and Symmetrel, etc.

Each patient is unique and different and, therefore, patients’ needs and reactions to their treatment will be different. What works for one may not be tolerated or work well for another. Hopefully, the drug treatment is scaled to your individual needs and will treat your symptoms, but only your doctor can decide with you what is best and what is needed. New steps are taken every day, and progress is made at nearly the same rate worked toward a cure. Until then, it is best for patients to follow their regimented treatments until something better comes along. It will if we all keep fighting and do not give up.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

The post Some Thoughts About Treating Parkinson’s Disease appeared first on Parkinson’s News Today.

Source: Parkinson's News Today

Parkinson’s Foundation’s New Initiative Links Patients’ Genetic Data to Clinical Care

genetic initiative

The Parkinson’s Foundation is establishing a new program offering genetic testing and counseling to Parkinson’s patients within its Centers of Excellence network to advance research, knowledge, and patient care.

The foundation’s new Genetic Initiative will create the largest database of genetic data for active Parkinson’s disease. The information will be collected via the Parkinson’s Outcomes Project — the largest, ongoing clinical study of the disease with more than 10,000 participants in five countries.

Linking genetic information to data on clinical progression and outcomes will contribute to scientific knowledge and research, and help improve care for patients.

“For people with Parkinson’s, genetic tests are either not available, not affordable, and not covered by health insurance or offered in tandem with genetic counseling,” John L. Lehr, CEO of the Parkinson’s Foundation, said in a press release. “We look to solve that by offering genetic testing, coupled with counseling in a clinical setting where doctors and patients can work together to best manage the disease.”

Providing genetic testing to Parkinson’s disease patients could also help accelerate clinical trials, ensuring patients know their genetic status to enroll in trials for specific gene variants.

“Most people with Parkinson’s do not know their genetic status and therefore do not know if they will be eligible for the next generation of clinical trials,” said Jon Stoessl, MD, chair of the Parkinson’s Foundation Scientific Advisory Board. “With this initiative, a patient’s genetic status will be available to help inform clinical decision-making from the start, as well as track and analyze outcomes over time in a more comprehensive fashion.”

While a genetic cause is estimated to contribute to 10-15 percent of Parkinson’s disease cases, researchers believe that environmental factors and their interplay with patients’ genetic background may determine the risk for developing the disease.

A comprehensive panel of experts — geneticists, clinicians, researchers, and ethics advisers — will be involved in the initiative. The first sites implementing the program will be announced in fall 2018. The foundation’s Centers of Excellence network includes 42 academic medical centers around the world, including 28 in the United States.

“What makes this initiative unique is its novel approach of offering genetic testing for relevant Parkinson’s-related genes in an easily accessible, clinical environment through our network,” said James Beck, PhD, chief scientific officer at the Parkinson’s Foundation. “We expect that this will accelerate enrollment in clinical trials for the next generation of treatments and help facilitate the use of genetic information to improve care and expand research.”

The idea to launch the Genetic Initiative was inspired by discussions with Roy Alcalay, MD, MS, an expert in the genetics of Parkinson’s disease and assistant professor of neurology at Columbia University, and a Parkinson’s Foundation Scientific Advisory Board Member.

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Source: Parkinson's News Today

Safety Watchdog ISMP Issues Alert on Acadia’s Nuplazid Therapy for Parkinson’s

Nuplazid alert

The Institute for Safe Medication Practices (ISMP) questions the approval of Acadia Pharmaceuticals’ antipsychotic therapy Nuplazid (pimavanserin) in the face of reports that it is ineffective in treating Parkinson’s disease and leads to severe adverse effects, including death.

Researchers shared these concerns in an article, “Safety Signals for Two Novel Drugs,” that appeared in the ISMP publication QuarterWatch. In it, the Pennsylvania-based ISMP issued a safety alert for the medication, and cautioned against combining Nuplazid with Seroquel (quetiapine) or other antipsychotics. It cautioned that such treatments are not recommended for older people, nor are they approved for use in Parkinson’s.

Unlike traditional antipsychotic medications — which mainly block dopamine signaling in the brain, Nuplazid blocks certain types of serotonin receptors. Blocking dopamine using other antipsychotics may trigger worsened movement symptoms in Parkinson’s patients, as these medications essentially counter the effect of levodopa and similar Parkinson’s treatments.

The U.S. Food and Drug Administration (FDA) approved Nuplazid in 2016, despite limited evidence of its effectiveness, ISMP noted.

The institute has access the all adverse events data, best known as MedWatch reports, sent to the FDA. The team noted that Nuplazid was among the 66 medications for which the FDA received 1,000 or more adverse events reports.

ISMP examined four main groups of adverse events for the treatment over the course of a year since Nuplazid’s approval. While the medication intends to treat psychotic symptoms — hallucinations and delusions — the main reported adverse event was hallucinations.

Nearly 22 percent of all reported adverse events were hallucinations. On second place were reports of lack of effectiveness, making up 15 percent of all reports. Confusion and death were the other two frequently reported issues.

This indicates that either the treatment is ineffective, or it worsens psychotic symptoms in some patients, ISMP said. Moreover, the data is consistent with that from the Phase 3 clinical trial (NCT01174004), which led to the medication’s approval.

In that study, both hallucinations and confusion were more common in treated patients compared with patients getting a placebo. An FDA medical reviewer had also underscored that Nuplazid treatment more than doubled the risk of death and serious adverse events in this trial, the ISMP underscored.

The reviewer had recommended against the approval of the treatment, based on this finding and the fact that Nuplazid was minimally effective — an effect assessed with an unvalidated tool. In addition, three earlier trials had failed to show a benefit from the treatment.

These facts made the ISMP side with the cautious reviewer, stating that “We found that pimavanserin was FDA-approved on limited scientific evidence that its benefits outweighed its risks.”

In addition to the adverse events reports, ISMP researchers also noted that many patients used Nuplazid together with Seroquel or other antipsychotics that block dopamine signaling. In addition to not being recommended or approved for the treatment of Parkinson’s psychosis, a recent review noted that there is no evidence that such combinations are effective.

The ISMP, however, gave Nuplazid’s maker, Acadia, a chance to comment on the observations.

The large numbers of adverse event reports, Acadia said, could partly be explained by the company’s extensive contact with health professionals and consumers through a specialty pharmacy network that distributes Nuplazid. Acadia also run a patient support program, which may improve reporting.

But the company also said that reports of hallucinations may reflect the slow onset of Nuplazid’s treatment effect — it takes four weeks for the treatment to be fully effective. Reported hallucinations may, therefore, have occurred before the drug became fully effective, it claimed.

“We share the FDA medical officer’s concerns about the approval of pimavanserin in the face of weak evidence of effectiveness, on the basis of a single small trial, and with increased rates of serious adverse events including death. The early but substantial adverse event data further support these concerns,” the ISMP concluded.

The post Safety Watchdog ISMP Issues Alert on Acadia’s Nuplazid Therapy for Parkinson’s appeared first on Parkinson’s News Today.

Source: Parkinson's News Today