Wednesday, September 21, 2022

Parkinson’s Disease Clinical Trials

What Are The Effects Of Parkinsons Disease

Breakthrough clinical trial could reverse symptoms of Parkinson’s Disease

Parkinson’s disease is chronic and progressive, but is not considered to be life threatening. The way that it progresses varies between patients.

Movement symptoms can vary from patient to patient. The extent to which these symptoms are bothersome depends on the activities in your daily life.

Some people with Parkinson’s disease have mild symptoms for many years, while for others the symptoms affecting movement progress quickly. Non-motor symptoms affect most people with Parkinson’s at all stages of disease however, the symptoms themselves also vary quite a bit between patients. People with Parkinson’s may find that non motor symptoms such as depression or fatigue have a greater impact on daily life than do movement problems.

Communication With Health Care Professionals About Off Periods

PwP and carepartners were asked to recall what aspects of OFF periods were discussed at the office visit. Discussion of motor aspects was reported by a higher proportion of both groups than non-motor aspects . A higher proportion of carepartners than PwP reported discussion of all aspects. Fifty nine percent of carepartners and 79% of PwP felt that the doctor understood the burden of OFF periods on their lives. Motor aspects of OFF periods were also the aspect most frequently reported as discussed by physicians , followed by the impact of OFF periods and on carepartners: 56% of general neurologists and 64% of movement disorder neurologists), followed by non-motor aspects .

The clinical interview was used by all neurologists to assess OFF periods. Including carepartners in the clinical interview was a frequent complementary method . The frequency of use of other methods such as questionnaires, diaries, wearable devices or direct observation are shown in .

What Does The On/off Phenomenon Feel Like

Off time is different for everyone, and depends on how your Parkinsons symptoms normally present themselves. Also referred to as motor fluctuations, you can tell your medication is wearing off early if some of your symptoms return. For some, tremor may be the first symptom to re-appear, while for others, it could be muscle stiffness, or non-motor symptoms such as a change in mood or thinking, or fatigue.

If you notice a change in your symptoms, especially if they interfere with your daily activities, its important to talk to your doctor. Before your appointment, try tracking when your off time starts and stops. Take note of how you feel when your medication is working optimally, compared with the changes youre experiencing.

On/off time is different from dyskinesia, which is uncontrolled movements that can look like smooth tics. Levodopa use can lead to dyskinesia, typically after a few years or more.

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What Causes Parkinsons Disease

The cause of Parkinsons disease is unknown however, both genetic and environmental factors may play a role.

Some people are more likely to develop Parkinsons disease. Factors that may increase risk include:

  • Age 60 and older
  • Parkinsons disease is a progressive disease of the nervous system.2,3
  • The exact cause of Parkinsons disease is unknown however, both genetic and environmental factors may play a role.1,6
  • An estimated 5 million people in the world including about 90,000 Canadians have Parkinsons disease.5
  • The average age of diagnosis is 60 but up to 20% of diagnoses are in people under 50.5,6
  • Parkinsons disease affects people, both men and women, of all races, occupations and countries.6
  • Tremor is the first symptom to appear in 70% of people with Parkinsons disease. About 30% never have a tremor.5
  • Parkinsons disease was first described by English physician Dr. James Parkinson in 1817.4
  • World Parkinson’s Disease Day is celebrated on the 11th of April.4

Do You Have An Off Story To Share

Researchers evaluate a pipeline of clinical trials targeting Parkinson ...

This post is the first in a series about what it means to be OFF. If you have a story about OFF and what youve done on your own and with your doctor that has helped you to minimize or navigate these periods, and youd like to share it with us, please send us an email at .

This post was written by the Davis Phinney Foundation.

This blog series is sponsored by Sunovion Pharmaceuticals Inc.

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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

What Causes On/off Episodes In Parkinsons Disease

On/off episodes, also known as off time, typically happen more often as Parkinsons disease progresses, and levodopa becomes less effective.

Carbidopa/levodopa is considered the gold standard in Parkinsons disease treatment, meaning its the most effective for treating motor symptoms, such as tremor, rigidity, and bradykinesia . Levodopa works by crossing the blood-brain barrier and converting into dopamine, low levels of which are believed to be the cause of Parkinsons symptoms. Adding carbidopa to levodopa helps prevent levodopa from breaking down before it crosses into the brain, which helps reduce side effects like nausea and vomiting.

Some people who have Parkinsons start taking levodopa at around three doses per day. If you start experiencing off episodes, your doctor may increase your dose to four or more times per day.

Off time is common: According to patient surveys, around half of patients who take levodopa report experiencing wearing off periods. Of those patients, 25% experience it 3 to 6 hours per day, and 52% have symptoms for 1 to 3 hours a day.

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Inhibikase Therapeutics Announces Dosing Of First Patient In Its Phase 2a ‘201’ Clinical Trial Of Ikt

News provided by

BOSTON and ATLANTA, Aug. 23, 2022 /PRNewswire/ — Inhibikase Therapeutics, Inc. , a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, today announced dosing of the first patient in its Phase 2a study evaluating IkT-148009, the Company’s novel Abelson Tyrosine Kinase, or c-Abl, inhibitor for the treatment of Parkinson’s disease.

“Dosing of the first patient in our Phase 2a ‘201’ trial represents a major milestone in the development of IkT-148009 for the treatment of Parkinson’s disease and related disorders,” commented Milton H. Werner, Ph.D., President and Chief Executive Officer. “Parkinson’s disease remains one of the most prevalent neurodegenerative disorders and affects nearly one million people in the U.S. annually. Our research continues to validate the critical role that c-Abl, a mechanistically defined target, plays in the initiation and progression of Parkinson’s disease, as well as the potential of IkT-148009 as a promising new approach to disease modification. Preclinical data in animal models of human PD suggested that functional recovery could be achieved in less than 8 weeks in animal.”

For more information regarding the trial design please see www.clinicaltrials.gov .

Contacts:

Movement Disorders Center Main Menu

What is a Parkinson’s clinical trial?

Your participation will allow you to have firsthand experience with developing new medical treatments that may be beneficial to others. Current treatment methods for neurologic disorders are only available because of volunteer participants in clinical trials. Clinical trial information is excerpted from www.clinicaltrials.gov.

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Help Your Patients Uncover The Troublesome Symptoms Of Off Periods9

Both physicians and patients agree: OFF periods can be one of the most difficult aspects of Parkinsons disease. Its understood that recognizing the symptoms of OFF periods is challenging because of a variety of reasons, including interpatient symptom variability and reliance on patient reporting.9

People with OFF periods may not discuss their symptoms or communicate the impact of the symptoms to their healthcare provider as they may be unaware that the changes they are experiencing are a result of OFF periods. Because patients may not recognize the more subtle changes they are experiencing as symptoms of OFF periods, enhancing communication around the full spectrum of symptoms is important.9

The Reality Of Managing Symptoms

Dr. Benjamin Walter, of the Center for Neuro-Restoration at Cleveland Clinic, said that the average person isnt accustomed to the strict regimen of multiple medications a day thats part of everyday life for people with Parkinsons.

Most people feel burdened just taking an antibiotic, which can be difficult to remember. Now, imagine someone who has Parkinsons the minimal dosing is usually three times a day, Walter said.

He explained that the need to frequently take medication is because it usually only lasts in a persons bloodstream for 90 minutes.

Once the medication gets into the brain, its converted to dopamine and stored in dopamine neurons, which recycles and reuses that medication over and over until it is depleted. Now, its not uncommon to have patients on meds four or five times a day, he said.

Walter stressed that when discussing Parkinsons and off periods, no two people are the same.

Parkinsons is a highly variable disease. Some people will experience different motor symptoms and tremors than others.

For example, some people freeze when they walk, while others dont.

He said the off periods can be terrifying for many people and also cause a different symptom anxiety.

Walter said that its important for those taking care of a person with Parkinsons to understand how dangerous off periods can be.

He stressed the importance of making sure patients get their medications on schedule so that everything is kept in working order.

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What Should I Know 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 studies 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 a 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.
  • About Our Research & Clinical Trials

    Parkinsons Disease Drug Therapies in the Clinical Trial Pipeline: 2020 ...

    Medical advances in the diagnosis and treatment of Parkinson’s disease offer hope to patients and families while also guiding the treatment plans developed by our team of PD specialists. That’s why the Parkinson’s Disease and Movement Disorders Center at BIDMC actively participates in multi-center clinical trials evaluating new treatments for PD.

    • We are members of the Parkinson Study Group, a national consortium of PD centers that carries out multi-center clinical trials of new medications for the treatment of PD.
    • We participate in several other leading-edge clinical research studies of new medications for PD.
    • We are actively participating in a National Institutes of Health initiative to identify therapies that may slow the progression of PD.
    • We are a National Parkinson’s Foundation Center of Excellence, which provides us with access to funding for clinical research, community outreach, and educational projects.

    To learn more about the clinical trials offered in the Parkinson’s Disease and Movement Disorders Center, please view our actively enrolling studies.

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    Study To Identify Clinical Imaging And Biologic Markers Of Parkinson Disease Progression

    Sorry, in progress, not accepting new patients

    This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease patients compared to healthy controls and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

    San Francisco, California

    How To Find The Right Trial For You

    There are several trials running at one time on a range of potential Parkinsons treatments. Some may run only in a particular country, while others may span many countries. A good place to start is by asking your doctor or neurologist if they are aware of any trials or research centres in your area. The resources and tools below will also help you find the right clinical trial for you.

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    How Are Clinical Trials Conducted

    Clinical trials that test drugs or interventions 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, range of possible side effects, and compare it with standard treatment or placebo.

    Phase IV trial: usually conducted on treatments that have already been Food and Drug Administration approved and is available to the general population. These trials help monitor the safety of the intervention in a larger population and obtain additional information about the benefits and use of the intervention.

    What Are The Benefits And Risks In Participating

    Parkinson’s Patients Preparing For ‘Breakthrough’ Clinical Trial To Reverse Symptoms

    There are many benefits to taking part in a clinical trial. You may feel that by doing so you are playing a more active role in your health as well as helping scientists to develop new medications to help other people with Parkinsons or move closer to the development of a cure. Participation can also provide opportunities to learn more about Parkinsons and to meet others in a similar situation. Participants can also play a key role in providing feedback on the trial design and therefore improve the format of future studies.

    The safety of participants is always paramount and there are strict codes of practice that must be observed to protect volunteers. Data protection is one key factor and participants names and personal details are not usually disclosed unless there is a medical reason to do so. This is covered by the new EU General Data Protection Regulation .

    However, as with any new treatment, there will always be an element of risk involved, although every care will be taken to eliminate the risk of serious or even life-threatening side effects. The phase I trial of the study is always designed to strictly assess the safety of the medicine and it will be terminated if any significant adverse effects are reported. Any potential side effects identified in phase I will then be carefully monitored and reported on in the later phases.

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    Where Is Drug Development Headed

    Overall, experts say the Parkinson’s disease field aims to develop therapies that can slow or stop disease progression. Kordower notes several promising gene therapy and stem cell therapy approaches are entering the early stages of clinical development.

    Most ongoing PD trials are at the Phase II stage, according to GlobalDatas Clinical Trial Database. While institutions are sponsoring 84 trials of the 133 ongoing Phase II studies , pharma companies are running 44 trials of the 56 ongoing Phase I studies .

    As the field awaits results from the slew of ongoing trials, experts agree that the PD trials reading out in the remainder of 2022 could have a substantial impact. These four trials are all very timely, Eidelberg says. The community of movement disorder specialists and neurologists would use these drugs because the indications we’re talking about are really very common.

    Related Companies

    Visual Hallucinations And Memory Impairment In Parkinsons Disease: The Role Of Hippocampal Networks

    Objective: The goal of this project is to assess the role of hippocampal networks in memory impairment and hallucinations in PD and determine whether hippocampal network dysfunction predicts greater cognitive and functional decline longitudinally.P.I.: Arnold Bakker, Ph.D., MA and Gregory Pontone, M.D.Contact: 410-502-4797 or

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    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.

    Developing And Testing A Compound In A Laboratory

    cure for Parkinson

    The initial research stage, which is usually carried out in the laboratory, tries to identify which chemical compounds may be the most promising for the development of new therapies. This may be due to their chemical structure, their mechanism of action or previous studies on the chemical which may suggest that it may be beneficial for the treatment of the nerve cells which die in Parkinsons. This is likely to include a detailed analysis of research papers which have been published for that compound.

    However, there is some evidence that drugs which have been developed for other conditions may also be beneficial for the treatment of Parkinsons this is termed drug repurposing. This is usually based on our growing understanding of how drugs work and also the changes that occur during the early stages of nerve cell death in Parkinsons. These drugs are more likely to modify the rate of progression of the disease rather than treat the symptoms.

    A third group are classed as Advanced Therapy Medicinal Products . These include products that will replace the cells that have died or alter the genetic make-up of the nerve cells to protect them. These agents are currently at an early stage of development.

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