MICROTABLET DISPENSER FOR MORE PRECISE L-DOPA DOSAGE

April 25, 2018

A study has assessed the effect of introducing a microtablet dose dispenser and adjusting doses based on the monitoring of motor symptoms in people with Parkinson's Disease. Forms of L-dopa are usually limited to certain doses and are consequently not adaptable to needs. A microtablet dose dispenser enables more precise doses of L-dopa.

Daytime doses of L-dopa were replaced with L-dopa / carbidopa microtablets, 5mg / 1.25 mg delivered from a dose dispenser device with programmable reminders. After two weeks, doses were adjusted based on ambulatory accelerometry and clinical monitoring. The daily L-dopa dose was increased by 15% from period 1 to 2, and the dose interval was reduced by 12% .

The MDS-UPDRS parts II and III, disease-specific quality of life (PDQ-8), wearing-off symptoms (WOQ-19), and nonmotor symptoms (NMS Quest) improved after dose increases. Evaluation of accelerometry results demonstrated improvement in 60% of subjects and worsening in 25% of them.

The introduction of an L-dopa microtablet dispenser and accelerometry aided dose adjustments Parkinson’s Disease improve symptoms and quality of life in the short term.

Reference : CNS Neuroscience and Therapeutics [2018] 24 (5) : 439-447 (D.Jan Johansson, A.Ericsson, A.Johansson, A.Medvedev, D.Nyholm, F.Ohlsson, M.Senek, J.Spira, I.Thomas, J.Westin, F.Bergquist)

Complete abstract : http://www.ncbi.nlm.nih.gov/pubmed/29652438

http://www.viartis.net/parkinsons.disease/news/180425.pdf

Most Parkinson’s Patients Show Non-movement Symptoms Like Depression, Sleep Problems, Survey Finds

 APRIL 26, 2018  BY PATRICIA INACIO, PHD 

Nearly all Parkinson’s disease patients experience non-movement symptoms, such as sleep disturbances or depression, which affect their quality of life as much as movement-related symptoms, according to an online survey of 700 participants, nearly 600 of whom completed it in full.

Patients’ caregivers are those most likely to detect non-movement manifestations of the disease.

These are the two main conclusion of the online survey, conducted by the Parkinson & Movement Disorder Alliance (PMDAlliance) with the support of Acadia Pharmaceuticals, as part of Parkinson’s Disease Awareness Month.

Of the survey’s respondents, 286 were Parkinson’s patients; 377 were care partners; 10 were noncare partners or family members of Parkinson’s patients; and 27 were categorized as “others.”

The survey, conducted online with members of the PMDAlliance from March 19-31, 2018, revealed that 90% of Parkinson’s patients show non-movement symptoms, manifested as sleep problems (84%), cognitive challenges (75%), anxiety (65%), depression (55%), hallucinations (41%), and delusions (24%).

The negative impact of non-movement symptoms on quality of life was recognized by 84% of the respondents, with nearly half of the patients (49%) finding coping with these symptoms even more challenging that Parkinson’s-related movement symptoms.

The non-movement side of the disease has a generally negative impact on the lives of patients, affecting their social activities with friends and family (70%), intimacy with their partner (68%), and with daily activities, such as household chores (68%) and running errands (67%).

“This survey clearly shows that non-movement symptoms of Parkinson’s disease make it difficult for people with Parkinson’s and their care partners to participate in activities most of us take for granted — running errands, going to the movies, eating out, or simply cooking and cleaning,” Sarah Jones, the CEO of PMDAlliance, said in a press release.

“We urge the entire Parkinson’s community — from the people with Parkinson’s and care partners, to healthcare professionals and support groups — to continue initiating conversations about Parkinson’s symptoms, especially the non-movement ones that greatly impact day-to-day living,” Jones said.

Despite its negative impact on quality of life, care partners detected the non-movement side of Parkinson’s two to four times more than patients themselves.

Hallucinations were observed by 51% of care partners and 23% of patients, and delusions were spotted by 32% of caregivers compared to 8% of patients.

These results both highlight and correlate with literature reporting that non-movement symptoms, like hallucinations and delusions, are often not reported to clinicians — only 10-20% of the cases are actually reported. This may be due to embarrassment or a misunderstanding that the symptoms are associated with the disease, since most of the time devoted to a patient’s visit with a doctor is generally focused on motor symptoms.

Other non-motor symptoms, such as cognitive challenges, anxiety, and depression were more easily detected by caregivers than patients.

“Parkinson’s disease changes how both people with PD [Parkinson’s disease] and care partners think about their future and cope with day-to-day living,” Jones said.

“Care partners are particularly attuned to how the disease is progressing in their loved one, which is why PMDAlliance added new educational resources to our website about the onset and impact of non-movement symptoms of PD,” she said.

“We want to encourage people to report symptoms to their healthcare providers, seek support, and participate in the community. This spring, we’re also hosting several Learn, Live, Connect educational conferences across the country where people can learn more about Parkinson’s disease and its many symptoms,” Jones added.

Doral Fredericks, PharmD (doctor of pharmacy), vice president of medical affairs at Acadia Pharmaceuticals, said Acadia is “honored to partner with PMDAlliance to highlight the impact of non-movement symptoms on both people with Parkinson’s and their care partners.

“We encourage people with Parkinson’s and caregivers to join the effort to raise awareness about this important aspect of Parkinson’s disease,” Fredericks added.

https://parkinsonsnewstoday.com/2018/04/26/parkinsons-patients-experience-non-movement-symptoms-survey-finds/

Molecule from Fat Burning Linked to Protein Clumps That Typify Parkinson’s in Study

APRIL 26, 2018 BY JOSE MARQUES LOPES, PHD

A molecule created by the brain burning fat for fuel can accumulate in some people and turn toxic, playing a key role in their possibly developing Parkinson’s disease,  researchers at Purdue University report.

These findings, in the study “Acrolein-mediated neuronal cell death and alpha-synuclein aggregation: implications for Parkinson’s Disease” published in Molecular and Cellular Neuroscience, could also aid in earlier disease diagnosis and new treatment discoveries.

The researchers found that acrolein, a byproduct of burning fat — which brain uses as fuel — that  is normally eliminated from the body can promote the accumulation of alpha-synuclein. This buildup, in turn, leads to nerve cell death in the substantia nigra, a brain area crucial for movement control. Damage to nerve cells in this region linked to clumping of the alpha-synuclein protein is a hallmark of Parkinson’s disease.

Using a rat model of Parkinson’s, the team observed that acrolein levels were unusually high in these rats and toxic, leading to  alpha-synuclein clumps in their brains.

Importantly, they also found a molecule that in these animals addressed both the toxic protein accumulation and the disease symptoms linked to it.

“Acrolein is a novel therapeutic target, so this is the first time it’s been shown in an animal model that if you lower the acrolein level you can actually slow the progression of the disease,” Riyi Shi, PhD, the study’s senior author, said in a Purdue news article written by Steve Tally. “This is very exciting. We’ve been working on this for more than 10 years.”

Early promise an animal model, however, may or may not lead to discoveries that help patients. “In decades of research, we’ve found many ways to cure Parkinson’s disease in pre-clinical animal studies, and yet we still don’t have a disease therapy that stops the underlying neurodegeneration in human patients,” said Jean-Christophe Rochet, PhD, a study co-author.

Still, “it’s possible that a drug therapy could be developed based on this information,” Rochet added. “We’ve shown that acrolein isn’t just serving as a bystander in Parkinson’s disease. It’s playing a direct role in the death of neurons.”

The investigators found that hydralazine, a molecule that widens blood vessels and lowers blood pressure  — and is an approved blood pressure treatment, eased behavioral problems in these rats, as well as in healthy rats injected with the compound.

Hydralazine, which scavenges acrolein, was also able to lessen neuronal death and lower levels of rotenone, another Parkinson’s-related toxin. “Luckily, this is a compound that can bind to the acrolein and remove it from the body,” Shi said. “It’s a drug already approved for use in humans, so we know there is no toxicity issue.”

Hydralazine may not be the best choice for Parkinson’s patients, however, due to its effects on blood pressure. But “we may find there is a therapeutic window, a lower dose, that could work without leading to unwanted side-effects,” Rochet said. “Regardless, this drug serves as a proof of principle for us to find other drugs that work as a scavenger for acrolein.”

In fact, the team has already “identified multiple candidates” that might “lower acrolein with similar or greater effectiveness, but without lowering blood pressure,” Rochet added.

This discovery might also allow earlier disease detection, Shi said, as acrolein levels “can be detected easily, such as using urine or blood,” meaning its levels could serve as a biomarker.

“The goal is that in the near future we can detect this toxin years before the onset of symptoms and initiate therapy to push back the disease … [maybe] indefinitely. That’s our theory and goal,” Shi added.

Rochet previously worked with a research team in Norway that showed that salbutamol, a common asthma medicine, could lower Parkinson’s risk by half, according to a University of Bergen 2017 report.

“Evidence suggests that salbutamol acts by a different mechanism than hydralazine — that is, by reducing alpha-synuclein accumulation — and thus perhaps salbutamol and an acrolein-scavenging drug could be used together to achieve an even greater therapeutic effect,” Rochet hypothesized.

https://parkinsonsnewstoday.com/2018/04/26/acrolein-molecule-created-by-burning-fat-linked-to-hallmark-parkinsons-protein-clumps-study/

Potential Treatment for Daytime Sleepiness in Parkinson’s Patients Moving to Phase 2 Trial

 APRIL 25, 2018 BY PATRICIA INACIO, PHD 

Theranexus announced it is starting a Phase 2 clinical trial investigating  THN102  as a potential therapy for Parkinson’s patients who struggle with inappropriate and excessive sleepiness during daytime hours.

The trial (2017-004475-31), which is planned to enroll 60 patients at 20 sites across Europe and in the U.S., was approved to start in Hungary, the French company announced in a press release. Requests to allow this trial have been submitted to regulatory agencies elsewhere.

Affecting almost half of all Parkinson’s patients, excessive daytime sleepiness is a common non-motor symptom of this disease.

The safety and tolerability of THN102 (modafinil/flecainide combination) capsules, given at two doses of each active agent — either 200 mg/18 mg or 200 mg/2 mg of modafinil/flecainide — will be compared to placebo.

Additional or secondary study goals include measuring the treatment’s effectiveness in easing sleepiness, improving patients’ attention spans, vigilance, and cognition, again relative to those given placebo.

Patients enrolled have disease-related excessive daytime sleepiness, denoted by a score of 14 or higher in the Epworth Sleepiness Scale, a self-administered questionnaire for which the highest score is 24. Eligible patients also are those who “complain of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g., falling asleep while reading or watching TV, while eating or talking with other people),” according to the trial’s official page.

THN102 is a combination therapy of modafinil, a first-line treatment for narcolepsy (a sleep disorder characterized by excessive sleepiness) and flecainide, a compound that acts on glial cells of the central nervous system. The therapy showed a safe profile in healthy volunteers deprived of sleep in a Phase 1 trial (NCT03182413), and is being tested in people with narcolepsy in a Phase 2 trial (NCT02821715) in France.

No treatments are approved to help Parkinson’s patients manage excessive daytime sleepiness.

“We would like to thank the regulatory agencies with whom we are in contact and we are delighted with this first authorisation for the phase 2 study for our drug candidate THN102 in Parkinson’s disease,” Franck Mouthon, CEO of Theranexus, said in the release.

https://parkinsonsnewstoday.com/2018/04/25/thn-102-eyed-potential-treatment-sleepy-parkinsons-patients/

Look for the Pockets of Hope

 APRIL 25, 2018    BY "SHERRI WOODBRIDGE"

If you’ve flown on an airplane from here to there and the weather was bad and visibility nil, you likely didn’t see much more than a layer of dark, gray clouds. However, every once in a while there is a little hole — a pocket — in which to view the earth below. Under that dark canopy are homes with people and cars driven by other people who are bustling down deserted roads. People who are hurting. People who are rejoicing. People who live with — and without — hope.

I think about being on the other side of that cloud cover where I have often stood under dark, gray clouds and looked up to see a little pocket of sunshine coming through the sky. Sometimes the rays have been so amazing that I often have felt a multitude of angels could come right there and then through that ray of brilliant sunshine. I have stood there, looking upward on those gray days and felt the warmth stream down through those little pockets of sunshine and upon my face. Something happens inside of me. My hope is restored.

I have focused on my surroundings so often that it can be hard to lift my head. However, I have a mighty God who sits enthroned up there where the sun still shines. He looks down below and sees and knows our state of mind and the condition of our spirits. That is why He gives us little pockets of hope, rays of sunshine that shine down upon us with their brilliance in our darkest moments. They encourage us to take a deep breath and focus above and know that God is still God and He is still in control. The little pockets of sunshine encourage us to keep going.

It’s not hard to look around and see chaos. We search within and can often find despair because of the trials in our life: our diseases, broken relationships, financial worries, and more. God looks around and sees a plan set into motion for our good. He sees wounded and weary spirits in need of hope and healing. We look up and see clouds that hide a clear view of who God is. We look up and fear the storms that are pressing in on us. He looks past and sees the rainbow He’s about to stretch across the sky. We see the now — He sees the tomorrows.

It can be difficult to find hope in the hard times. It can be hard to find sunshine in the storms. But, as the winds of broken dreams and the rains of helplessness beat against us and wear us down, that’s when He does it.

He reaches down and gently parts the gray skies, sending a brilliant ray of light that spreads over the chaos around us. A ray of light that is captivating — luring even — as we stand there and soak up the warmth He is pouring down upon us. Amazing hope that builds up our faltering faith. Hope that gives us the strength to press on through the storms of this life.

That is why I write. To hopefully show you that there is indeed hope for those who are weary, for those who are hurting. To offer a little something that might make you smile — laugh even — as you journey through this hard life.

God has given me countless little pockets of hope on the darkest of days, and I have learned to look for them in the hard times. They are there. I have seen them. The trick is to look for the light and not focus on the dark clouds hanging overhead.

Lift your face from despair, from fear and hopelessness, and look up — up to Him — and He will give you those little pockets of hope. Hope that will break through on even the darkest of days. That’s a promise.

***

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.

https://parkinsonsnewstoday.com/2018/04/25/parkinsons-darkest-days-look-pockets-hope/

Exercise to change the brain

April 26, 2018, McGill University

For someone with Parkinson's disease (PD), the simple desire to grasp a glass of water can become an insurmountable task, made impossible by the tremors in their hand or arm. Finding strategies to improve these movement impairments is one of the major goals of rehabilitating people with Parkinson's disease.

At McGill University, Dr. Marc Roig, an assistant professor in the School of Physical and Occupational Therapy (SPOT), is studying the effects of using high-intensity exercise to stimulate the brain's ability to learn and change with repeated experiences.

Dr. Roig and his team are working with people who have Parkinson's disease, to see if they can improve their ability to move and to complete tasks like grabbing an object. The team is using high-intensity cardiovascular exercise to provoke changes in the brain that make it easier to train itself to relearn motor tasks.

"One of the main problems with people with Parkinson's is they lose their ability to do very simple motor tasks," says Dr. Roig, a neuroscientist. "We are trying to understand why this happens and find interventions to improve that."

Dr. Roig believes exercise may be the key to triggering the brain's ability to change and to open a window to improve motor learning. His current study is using Transcranial Magnetic Stimulation, a form of non-invasive brain imaging that moves a magnetic coil over the skull, to map the areas of the brain he wants to measure. By attaching electrodes to the muscles of the hand and then moving the magnetic coil until the fingers move, his team is able to map the changes in the brain that occur before and after intense exercise, and to record changes in the brain activity of people with Parkinson's who are on medication and those who are not on medication.

After they exercise, study participants are asked to complete a task involving the application of force in a computer game, to measure whether the exercise and the burst of brain chemicals it stimulates also improves their motor ability.

Most people with Parkinson's disease eventually take a synthetic form of dopamine, called levodopa, to replace the levels of this brain signalling chemical that Parkinson's depletes. Roig is also testing his theory that the people with Parkinson's will need their medication to take advantage of the improvements exercise can produce.

"With the new information, we can better understand how exercise interacts with dopamine and with motor learning," Roig says.

His goal is to use that information to create new interventions during rehabilitation, and to explore the response of different areas of the brain. "If we can show that exercise interacts positively with medication, the next step would be to establish whether coupling exercise with medication has long-term benefits for people with PD," explains Dr. Roig. "This could be accomplished by studying the long term effects of exercise and medication taken together on the motor and cognitive alterations caused by the disease."

Dr. Roig notes that the study is going well, though they are in need of additional participants in order to complete the study. "To date, we have tested 19 people with PD. We predicted that we would need 48 people to finalize the study."

Dr. Roig and his team are looking for people with PD aged 45 to 80, who would be willing to travel to his lab on three occasions, with a total time commitment of five to six hours. "On the first visit, we measure their cardiorespiratory fitness with an exercise test," explains Dr. Roig. "This is important to assess their suitability for the study but also to know how fit they are. On the second visit, we ask them to practice a motor task followed by 15 minutes of exercise or rest. We also measure changes in their brain activity using a non-invasive brainstimulation technique, which is completely safe and painless. We ask them to return 48 hours later for a short third visit to assess their capacity to remember the task that they practiced on the second visit. We provide a generous compensation that covers for parking and transportation expenses."

For her part Eileen Cortina recognizes the value in participating in this study. "I find it so important to participate in studies for Parkinson's because even though we are always too young to be diagnosed, we are never too old to hope for a cure," she says. "I hope that they find a solution to help people with the dexterity part of this disease as this is what bothers me most at this time, even more than the fatigue, pain and other symptoms."

"The final goal is to try to improve the quality of life of these people, but to do that you need to understand the mechanisms of the disease," says Dr. Roig.

Eventually, his work may lead to new techniques and new rehabilitative interventions that can help people with Parkinson's use exercise to train their brains to complete the simple tasks of everyday life that come so easily to others without this disease.

If you or someone you know would be interested in participating in this study, contact Dr. Roig at (515) 415-8353 or marc.roigpull [at] mcgill.ca ().

Provided by: McGill University

https://medicalxpress.com/news/2018-04-brain_1.html

Common class of drugs linked to dementia even when taken 20 years before diagnosis

April 26, 2018, Regenstrief Institute

The largest and most detailed study of the long-term impact of anticholinergic drugs, a class of drugs commonly prescribed in the United States and United Kingdom as antidepressants and incontinence medications, has found that their use is associated with increased risk of dementia, even when taken 20 years before diagnosis of cognitive impairment.

An international research team from the US, UK and Ireland analyzed more than 27 million prescriptions as recorded in the medical records of 40,770 patients over age 65 diagnosed with dementia compared to the records of 283,933 older adults without dementia.

The researchers found greater incidence of dementia among patients prescribed anticholinergic antidepressants, anticholinergic bladder medications and anticholinergic Parkinson's disease medications than among older adults who were not prescribed these drugs.

Dementia increased with greater exposure to anticholinergic medications.

"Anticholinergic Medication and Risk of Dementia: Case-control Study" is published in BMJ (formerly the British Medical Journal) an international peer-reviewed medical journal.

"Anticholinergics, medications that block acetylcholine, a nervous system neurotransmitter, have previously been implicated as a potential cause of cognitive impairment," said Regenstrief Institute and Indiana University Center for Aging Research investigator Noll Campbell, PharmD, MS, a co-author of the new BMJ study. "This study is large enough to evaluate the long-term effect and determine that harm may be experienced years before a diagnosis of dementia is made." Dr. Campbell is also an assistant professor of pharmacy practice at Purdue University College of Pharmacy.

"These findings make it clear that clinicians need to carefully consider the anticholinergic burden of their patients and weigh other options," said study co-author Malaz Boustani, M.D., MPH, a Regenstrief Institute and IU Center for Aging Research investigator. Dr. Boustani is the founder of the Indiana Clinical and Translational Science Institute's IU Center for Health Innovation and Implementation Science and the Richard M. Fairbanks Professor of Aging Research at IU School of Medicine.

"Physicians should review all the anticholinergic medications - including over-the-counter drugs - that patients of all ages are taking and determine safe ways to take individuals off anticholinergic medications in the interest of preserving brain health," Dr. Boustani said.

The study, which was led by the University of East Anglia and funded by the Alzheimer's Society, both in the UK, utilized data from the Clinical Practice Research Datalink which includes anonymized diagnosis, referral and prescription records for more than 11 million patients from 674 primary care practices across the UK. The data is broadly representative of the UK population in terms of age, sex and ethnicity.

"This research is really important because there are an estimated 350 million people affected globally by depression. Bladder conditions requiring treatment are estimated to affect over 13 percent of men and 30 percent of women in the UK and US," said study lead researcher George Savva, PhD, visiting researcher at University of East Anglia's School of Health Sciences.

"We don't know exactly how anticholinergics might cause dementia," said study co-author Chris Fox, MD, professor of clinical psychiatry at UEA's Norwich Medical School and a consultant psychiatrist. "Further research is needed to understand possible reasons for this link. In the meantime, I strongly advise patients with any concerns to continue taking their medicines until they have consulted their doctor or pharmacist."

Study co-author Ian Maidment, PhD, senior lecturer in clinical pharmacy at Aston University in the UK, said: "With many medicines having some anticholinergic activity, one key focus should be de-prescribing. Clinical staff, patients and carers need to work together collaboratively to limit the potential harm associated with anticholinergics."

https://youtu.be/xWJF6HdEMtE

More information: Kathryn Richardson et al. Anticholinergic drugs and risk of dementia: case-control study, BMJ (2018). DOI: 10.1136/bmj.k1315

Editorial: Anticholinergic drugs and dementia in older adults, www.bmj.com/content/361/bmj.k1722 

Journal reference: British Medical Journal (BMJ)

Provided by: Regenstrief Institute 

https://medicalxpress.com/news/2018-04-common-class-drugs-linked-dementia.html

Rabies trick could help treat Parkinson's disease

April 25, 2018

Source:

American Chemical Society

Summary:

The rabies virus wreaks havoc on the brain, triggering psychosis and death. To get where it needs to go, the virus must first trick the nervous system and cross the blood brain barrier -- a process that makes it of interest in drug design. Now, scientists report a way to exploit the rabies virus machinery to deliver a Parkinson's disease medication directly to the brain.

The rabies virus wreaks havoc on the brain, triggering psychosis and death. To get where it needs to go, the virus must first trick the nervous system and cross the blood brain barrier -- a process that makes it of interest in drug design. Now, scientists report in ACS Nano a way to exploit the rabies virus machinery to deliver a Parkinson's disease medication directly to the brain.

Parkinson's disease, the slow degeneration of the brain cells that control movement, affects about a million Americans, according to the Parkinson's Foundation, and has no cure. While the exact cause of Parkinson's disease is unknown, a common feature of the illness is the accumulation of iron in neurons, inflicting damage and cell death. Some doctors are now using a metal-grabbing compound called deferoxamine to sop up the excess iron in patients, but high doses are needed due to the drug's limited capacity to enter the brain, bringing on serious side effects. To lower the effective dose, Yan-Zhong Chang, Xin Lou, Guangjun Nie, and colleagues wanted to take advantage of a key part of the rabies virus to usher deferoxamine into the brain.

Glycoprotein 29 is a part of the rabies virus that binds to a brain cell receptor and crosses the blood brain barrier. The researchers attached glycoprotein 29 to a nanoparticle stuffed full of deferoxamine. Then, they injected the iron-grabbing nanoparticles into mouse models of Parkinson's disease. The iron levels in the mouse brains dropped, reducing the brain damage and reversing the disease symptoms, without noticeable side effects. Since all of the components in the therapeutic agent are already approved for use in the clinic, the researchers are looking toward human trials.

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Story Source:

Materials provided by American Chemical Society. Note: Content may be edited for style and length.

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Journal Reference:

1. Linhao You, Jing Wang, Tianqing Liu, Yinlong Zhang, Xuexiang Han, Ting Wang, Shanshan Guo, Tianyu Dong, Junchao Xu, Gregory J. Anderson, Qiang Liu, Yan-Zhong Chang, Xin Lou, Guangjun Nie. Targeted Brain Delivery of Rabies Virus Glycoprotein 29-Modified Deferoxamine-Loaded Nanoparticles Reverses Functional Deficits in Parkinsonian Mice. ACS Nano, 2018; DOI: 10.1021/acsnano.7b08172

https://www.sciencedaily.com/releases/2018/04/180425120200.htm

PMDAlliance Will Share ’emPowered!’ to Improve Doctor-Patient Communications

 APRIL 24, 2018 BY CAROLINA HENRIQUES 

To make the most of the limited time Parkinson’s disease patients and physicians have during an office visit, the nonprofit Parkinson’s & Movement Disorder Alliance (PMDAlliance) has created emPowered!, a new tool for tracking symptoms and reporting them to healthcare providers.

The booklet, in which patients will log information about medications and daily activities, for example, is  designed to help patients focus on the most important or troublesome changes in condition. Because time constraints often limit what patients and physicians discuss, it is critical that important information is readily available during an appointment.

A survey conducted during the 2017 World Parkinson Congress in Portland, Oregon, revealed that 22 percent of patients said they felt like a burden when talking about their problems with their doctors. In addition, 30 percent said they felt as if they were complaining when they talked about issues regarding their medication.

“In conversations with thousands of people across the country who are impacted by Parkinson’s disease, we recognize a consistent need — to learn how to advocate for oneself during an appointment with the physician,” Sarah Jones, CEO of PMDAlliance, said in a press release.

“Add this barrier to an incredibly complex disease like Parkinson’s and the issue is compounded,” Jones added. “Every week I speak with someone who has a symptom that may be tied to Parkinson’s disease, but they don’t realize it. Combined with a hesitation to tell their doctor, the result is that they may not receive the full benefits of their doctor’s care.”

PMDAlliance will start distributing emPowered! at its upcoming Learn.Live.Connect conference in Boston, April 27.

Each attendee will receive emPowered! and training on how to best use the tool. Participants also will have the opportunity to learn more about the disease from two U.S. experts, Laxman Bahroo, DO, and David Shprecher, DO, who will talk about medical and surgical management of Parkinson’s, and the latest treatment options available for patients with movement disorders.

Representatives from leading movement disorder centers also will be present at the conference to provide in-person information about how to access their services.

Bahroo is the director of the Neurology Residency Program at Georgetown University Hospital. Shprecher is the director of the Movement Disorder Program at Banner Sun Health Research Institute in Phoenix, Arizona.

https://parkinsonsnewstoday.com/2018/04/24/pmdalliance-will-share-tool-improve-doctor-patient-communications/

Gocovri Improves Dyskinesia in Parkinson’s Patients Over Long Term, Phase 3 Trial Shows

APRIL 24, 2018 BY PATRICIA INACIO, PHD 

Gocovri (amantadine) extended release oral capsules provided long-term improvements of motor complications in Parkinson’s disease patients, according to results from a Phase 3 clinical trial.

Gocovri, developed by Adamas Pharmaceuticals, is the only medication approved by the U.S. Food and Drug Administration for the treatment of dyskinesia — involuntary, jerky movements — in Parkinson’s patients who receive levodopa-based therapy, with or without accompanying dopaminergic medications.

“When coupled with the Phase 3 controlled studies, this completed open-label study provides supportive evidence that GOCOVRI was able to provide a treatment effect for up to 100 weeks, without waning of benefit in the majority of patients,” Robert Hauser, MD, professor of neurology and director of the USF Health Byrd Parkinson’s Disease and Movement Disorders Center, said in a press release.

EASE LID 2 (NCT02202551) was a two-year, open-label study that evaluated the long-term safety, tolerability, and effectiveness of Gocovri in Parkinson’s patients with levodopa-induced dyskinesia. Patients received the therapy once daily at bedtime.

The study enrolled 223 patients from three previous trials — EASED (NCT01397422), EASE LID (NCT02136914) and EASE LID 3 (NCT02274766 ) — which assessed and compared Gocovri’s effectiveness versus placebo-randomized controls.

Also included in the study were a subgroup of patients with uncontrollable dyskinesia who had deep brain stimulation — the most common surgery used to treat Parkinson’s symptomsby delivering electrical pulses to brain cells.

Researchers tested the therapy’s effectiveness by measuring patients’ clinical progression using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). This scale is divided into four parts: Part I focuses on non-motor experiences of daily living, Part II on motor experiences of daily living, Part III on motor examination, and Part IV on motor complications.

Results showed that by the end of the two-year treatment, patients’ scores on the MDS-UPDRS Part IV, assessing motor complications, showed a change of -2.4 units in patients previously treated with placebo, -3.5 units in patients who took amantadine immediate release, and -3.6 units in patients who had deep brain stimulation.

In patients who were already on Gocovri, changes in MDS-UPDRS, Part IV scores were less pronounced — only 0.4 units — confirming the therapy’s effectiveness even before long-term treatment.

“The completed Phase 3 open-label study further expands our understanding of the benefit/risk profile of GOCOVRI,” said Rajiv Patni, MD, chief medical officer of Adamas Pharmaceuticals. “The large reduction in dyskinesia and OFF, as assessed by the Part IV score of the MDS-UPDRS, was observed by the first visit at Week 8 and was sustained for two years. This durability is noteworthy given the known progression of motor complications.”

Gocovri’s safety profile is in line with previous reports. The most common adverse reactions included falls, hallucinations, peripheral edemas, constipation, and urinary tract infections, but these were generally mild to moderate. During the two-year study, 9% of the patients discontinued the treatment due to adverse effects, and nine patients died, although no death was linked to Gocovri.

“Nine percent of patients discontinued GOCOVRI due to an adverse drug reaction over this prolonged treatment period and the safety as well as tolerability remained consistent with that obtained from the 64-week data cut from December 2016,” Patni said.

“Lastly, by two years, 30 percent of patients increased their levodopa dose by an average of approximately 300 mg, suggesting that GOCOVRI treatment may allow neurologists to further optimize their patient’s levodopa dose despite the occurrence of dyskinesia,” he said.

These new findings will be presented at the 22nd International Congress of Parkinson’s Disease and Movement Disorders Oct. 5-9 in Hong Kong, China.

“These data suggest that further research is warranted to assess whether GOCOVRI could potentially delay the onset or reduce the progression of motor complications,” Hauser said.

https://parkinsonsnewstoday.com/2018/04/24/gocovri-improves-dyskinesia-over-long-term-parkinsons-phase-3-trial/