Saturday, August 6, 2022

Parkinson’s Vaccine Clinical Trials

What Are The Most Common Covid

Duke institute lands federal contract to make vaccines for clinical trials

Dr. Okun: We are just starting to get the information on clinical Parkinsons symptoms and COVID-19. One study in Milan, Italy, reported that motor and non-motor symptoms seemed to worsen with COVID-19, and that medication adjustments were required in a third of people with PD and COVID-19. Researchers hypothesized that the COVID-19 infection, the Parkinsons medications, and the immune system, together create a perfect storm to worsen Parkinsons symptoms. The most common symptoms encountered were urinary issues, fatigue, cognitive dysfunction and confusion. We are seeing many patients who survive COVID-19 and require that their PD medications be adjusted. Similarly, we are also finding that in the hospital, a neurologist with expertise in Parkinsons can help in decision making for those with COVID-19.

How Are Clinical Trials Conducted

Clinical trials that test drugs are conducted in a series of carefully monitored phases designed to answer specific questions.

Phase I trial: researchers test a new drug or treatment in people for the first time. A small group of people, typically fewer than 100, are monitored to evaluate the drug or treatment’s safety, determine a safe dosage range and identify side effects.

Phase II trial: study the effectiveness of a drug or treatment in a larger group of people.

Phase III trial: the study drug or treatment is given to a large group of several hundred to several thousand people. This large-scale testing gives more detailed information about the drug’s benefits, effectiveness and range of possible side effects.

Phase IV trial: usually conducted on drugs that have already been FDA-approved. These trials are run to determine additional uses for an approved drug or further study its safety in large numbers of participants.

March 2020 Affiris Granted New Patent In China For Treating Parkinson’s Disease

Patent adds to companys robust portfolio covering clinical stage lead development candidate PD01

Vienna, Austria, March 3, 2020 AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies for patients with neurodegenerative diseases, today announces the award of a new patent by the Chinese National Intellectual Property Administration . The patent covers a group of AFFITOPEs, including PD01, the Companys lead candidate for the treatment of early-stage Parkinsons disease patients which is expected to enter clinical phase 2 in the second half of 2020.

AFFiRiS, which has already obtained patents in the United States, Europe, Australia, Canada, India, Japan and South Korea for the same application, thus further expand the geographic coverage of its intellectual property portfolio thanks to this new patent. In addition, the newly granted IP adds to AFFiRiS broad patent position covering the treatment of Parkinsons disease, and its product candidate PD01, as well as to its overall body of patents and patent applications, reflecting the excellent competitive profile in the field of neurodegenerative treatments.

About AFFITOPE® PD01:

About Parkinsons disease:

About AFFiRiS AG:

Contact AFFiRiS AG: Media contact:

Dr. Cornelia Kutzer MC Services

E Julia Hofmann

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Parkinson Progression Marker Initiative Online

open to eligible people ages 18 years and up

Parkinson Progression Marker Initiative Online is an observational study collecting participant reported information from people with and without Parkinson’s disease , for the goal of better understanding risk and predictive factors for PD. PPMI Online is part of the broader Parkinson Progression Marker Initiative aimed at identifying markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

San Francisco, California

When We Think About Vaccinations We Generally Associate Them With Infectious Conditions Like Meningitis And Tuberculosis Rather Than Parkinsons But Now There Is Promise For Vaccines In Clinical Trials For Parkinsons

Italian DNA

Using vaccination, over the last 100 years weve been able to almost entirely wipe out conditions such as smallpox and polio. Vaccinations are a simple way of preparing our bodies to tackle unwanted infections.

When we have a vaccination, we are injected with tiny fragments of the virus that causes the illness. These fragments are not enough to make us ill. But they do allow our bodies to generate an immune response, a defence against the foreign invader.

Specialised proteins called antibodies make up part of this defence. These help identify and mark foreign invaders for destruction, as they trigger other cells to come and destroy them.

Antibodies are very clever proteins. As well as being part of our bodies defence system they act as this systems memory. So if our body is infected with the same foreign invader, we already have the weapons to defend ourselves.

We are probably fighting infections all the time but because of this memory to rapidly fight the invader, we do not even notice the infection. This is how vaccination works, if we have a flu jab for instance then this allows our body to make and store the weapons to fight this particular strain of flu. When we come across the same strain of flu after vaccination we should be able to fight it off with these stored weapons without becoming ill.

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Udall Center Brain Donation Program

Objective: Examine the pathological changes in the brain tissue of individuals diagnosed with Parkinson’s disease or related disorders as compared to controlsEligibility: Individuals diagnosed with Parkinson’s disease or atypical Parkinson’s disease and those without a neurological diagnosisP.I.: Liana Rosenthal, M.D.Contact: Catherine Bakker:

The Parkinsons Disease News Today Forums Are A Place To Connect With Other Patients Share Tips And Talk About The Latest Research Check Them Out Today

Patients with neurodegenerative diseases such as Parkinsons disease face an all-too-predictable future and are in urgent need of therapies that alter the course of disease progression. Although there are many treatments available to manage the devastating symptoms, sadly none of these acts on the underlying cause of the disease. However, AFFiRiS unique immunological approach provides a disease-modifying therapy with an excellent competitive in the field of neurodegenerative treatments, Rossella Medori, MD, chief medical officer at AFFiRiS, said in a press release.

Although vaccinating against Parkinsons is not a widespread strategy, Affiris is not alone. In late 2018, United Neuroscience developed its own candidate molecule to induce an immune response against alpha-synuclein, and Prothena is currently conducting a Phase 2 trial of an injectable antibody against alpha-synuclein .

Founded in 2003, Affiris has been dedicated to using the immune system to cure neurodegenerative diseases. They currently investigate therapies for Parkinsons, Alzheimers, multiple system atrophy, dementia with Lewy bodies, and Huntingtons disease.

Affiris has not announced when or where its upcoming Phase 2 Affitope trial will take place.

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What Should I Think About Before Participating In A Clinical Study

Talk to your doctor first. Sometimes you may find out about research from the internet or an advertisement. Talk to a doctor you trust before you agree to participate.

Look for research studied conducted by a reputable institution. The Parkinsons Foundations Centers of Excellence and other top academic medical centers are trustworthy institutions that have rules in place related to the protection of human research subjects. If you are recruited for a clinical trial by your local doctor, look up the trial on ClinicalTrials.gov. If the doctor leading the trial is not affiliated with a reputable university or major research hospital and the trial is not listed in ClinicalTrials.gov, be careful and do your research.

Read the consent form carefully. It is important that no one forces you to participate. Before you sign up, you will be part of the informed consent process. The consent form should be written in a language you understand. The researchers should explain the risks and benefits of the study. Ask questions if something is confusing or unclear. Take time to understand what you are signing up for. Understand your rights if you agree to participate now, but wish to withdraw later.

How Could This Work For Parkinsons

Moderna set to begin clinical trials for an HIV vaccine

Parkinsons is not an infectious illness. So how could a vaccine help?

If we look towards cancer, not an infectious disease, there has been success using the bodys immune response to target cancer cells. For instance using cells from the immune system to stop the growth of cancer cells or mark them for destruction. These treatments are referred to as immunotherapies and you may have seen this word in the headlines. A similar approach of using the bodys own immune response to slow down Parkinsons is currently being studied.

Brain cells are lost in Parkinsons and research has shown that in these brain cells there is a build-up of a sticky protein called alpha-synuclein. These sticky proteins form clumps called Lewy bodies which may play a crucial part in the death of these vital brain cells. This makes alpha-synuclein a good target to slow down Parkinsons.

There is a second method which is an active vaccination approach which works like a flu vaccination. The active approach could help the immune system develop memory and potentially target alpha-synuclein over a longer period of time.

Will it work?

Dr Patrick Lewis, University of Reading explains

Most of the early work on vaccines for brain disorders comes from research into Alzheimers. Scientists investigated ways to clear lumps of protein , which accumulates in clumps called plaques, in the brains of people with dementia.

Overcoming hurdles of autoimmunity

Where are we now?

BIIB054

Prasinezumab

MEDI1341

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New Clinical Trials Targeting The Lrrk2 Gene

LRRK2 is a protein that becomes hyperactive in some people with Parkinsons, and this increased level of activity is believed to be involved in the progression of their Parkinsons. Now, two biotech companies have announced plans for two new clinical trials to test their LRRK2 inhibitor drug to reduce this hyperactivity, to try to slow or stop the progression of Parkinsons.

Approximately 1% of people with Parkinsons have a small mutation in their DNA in a region called the LRRK2 gene. This gene provides the instructions for making a protein called Leucine Rich Repeat Kinase 2 . Normally, the LRRK2 protein plays important roles in the biology of cells, but in people with this LRRK2 gene variant, the LRRK2 protein becomes hyperactive. This overactive version of the protein is associated with an increased risk of developing Parkinsons, and it is believed to play a role in the progression of the symptoms of the condition.

Scientists have been searching for medicines that will reduce the activity of the LRRK2 protein in the hope that this might provide a means of slowing down the progression of Parkinsons in people with hyperactive forms of LRRK2. Biotech company Denali Therapeutics, has been leading the development in this field of research. Now, they have joined forces with another biotech company, Biogen, to progress two large clinical trials to evaluate their LRRK2 inhibitor, BIIB122.

Trial Of Parkinson’s And Zoledronic Acid

open to eligible people ages 60 years and up

This home-based study is a randomized placebo-controlled trial of a single infusion of zoledronic acid-5 mg for the prevention of fractures in men and women aged 60 years and older with Parkinson’s disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.

San Francisco, California

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Why Should I Participate In A Clinical Study

We can only reach breakthroughs in treatment and care if people participate in the studies.

Participating is safe and can help you.

Every clinical study is reviewed thoroughly before your doctor asks you to participate. Clinical trials carry some risks, but your doctor is required by law to explain the risks to you clearly and make sure that you understand them. If your doctor tells you about the risks of participating in the study, ask yourself, What are the risks of not participating in the study? Most of the time, if you balance the possible benefits from participating against the risks, it is about the same as the risks of not being in the study.

On the other hand, the study may be of a new drug or treatment that could help you. If you dont participate, it may be years before you have a chance to try that drug.

Some people do not participate because there is no guarantee they will get the experimental therapy they might get the placebo. Again, think carefully about the risks and benefits of entering the study and getting the new treatment, entering the study and getting the placebo or not entering the study at all.

Your participation can help others

If you have PD or any other disease, the drugs, procedures and therapies you use now were scientifically tested, likely by thousands of volunteers. Participating in a clinical trial is your way to pay it forward for people diagnosed with Parkinsons in the future.

Where Can I Sign Up For A Clinical Study

Novavax begins clinical trials of COVID

The Parkinsons Outcomes Project is the largest clinical study ever conducted in Parkinsons disease. The goal of the study is to identify and explain factors that result in longer, better and more active lives for people with PD. Twenty Centers of Excellence are participating in the study.

ClinicalTrials.gov is a registry and database of publicly and privately support clinical studies conducted around the world. This website is a service of the National Institutes of Health and is the best place to find up-to-date information on trials enrolling participants. NIH Clinical Trials and You provides a step-by-step guide to finding trials on ClinicalTrials.gov.

Fox Trial FinderWeb-based clinical trial matching tool to connect those with and without PD to Parkinsons clinical research opportunities that urgently need participants. After volunteers input information about themselves , Fox Trial Finder provides trial match suggestions. Volunteers can connect directly with trial coordinators through a secure messaging interface. Register today to play a part in accelerating recruitment into PD clinical research. foxtrialfinder.michaeljfox.org.

CenterwatchAn information service for patients, pharmaceutical companies and research centers involved in clinical research. Centerwatch publishes a wide range of newsletters, books and directories. www.centerwatch.com

  • Review an extensive list of clinical trials being conducted across the world.

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The Future Of Vaccinations For Parkinsons

Targeting alpha-synuclein offers a promising way to stop the toxic effects of this protein in Parkinsons. But before we see these vaccines available, more trials will need to be done to see the long-term safety and impact on symptoms and progression.

This isnt the only way researchers are tackling alpha-synuclein. Similar trials of treatments that target alpha-synuclein are being carried out through more conventional drug development channels.

Parkinson’s Advocates In Research

The Parkinson’s Disease Foundationâs Parkinson’s Advocates in Research program is a patient-based initiative that ensures people with Parkinson’s disease have a role in shaping the clinical research process. By training advocates with Parkinson’s disease to serve as patient representatives on clinical research advisory boards, the PAIR program aims to improve outcomes by helping researchers overcome and identify barriers in research that they may otherwise overlook. Participants in the PAIR program receive training through PDF’s Clinical Research Learning Institute, an annual multi-day training that focuses on education via training sessions, clinical researcher led workshops, as well as interaction with study coordinators and representatives from both the government and the industry.

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How Can I Access The Vaccine

Dr. Okun: In the U.S., the vaccine is being distributed to each of the 50 states, and each state has a different process for distribution. In most states, the vaccine is currently being administered to frontline healthcare workers, and eventually it will be distributed by age and priority levels. We wrote a recent blog article on access to the COVID-19 vaccine. Tips to access the vaccine include:

  • Check in with your local health department. Some have a sign-up list so that you can access appointments online or by calling.
  • Check in with your primary doctor and let him/her know you want the vaccine.
  • Dont wait in line for hours or camp out without social distancing. Ideally, get an appointment.

We are working on getting people with Parkinsons to be listed as a 1b priority, meaning they would get priority in receiving the vaccine. If it were up to me, Id be vaccinating everyone with Parkinsons disease early in the process , and Id do it tomorrow.

Guidance on who will receive the COVID-19 vaccine at each stage of the rollout is determined at the state level. Contact your states health department for details about when you and your loved ones will be eligible to receive the COVID-19 vaccine. Find your states health department.

Study In Parkinson Disease Of Exercise

China’s fourth Covid-19 vaccine enters clinical trials

open to eligible people ages 40-80

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson’s disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease when they perform high-intensity endurance treadmill exercise.

San Francisco, California

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A Study To Evaluate The Efficacy Of Prasinezumab In Participants With Early Parkinson’s Disease

Sorry, in progress, not accepting new patients

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab versus placebo over 52 weeks in participants with early Parkinson’s Disease who are untreated or treated with monoamine oxidase B inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks . Participants who complete Part 2 will be offered participation in Part 3 open-label extension for an additional 260 weeks.

San Francisco, California

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