Clinical Trials
Drugs and devices must go through a process of clinical trials before the U.S. Food and Drug Administration (FDA) to be considered an approved new therapy. A clinical trial, also called a clinical study or clinical research, is research conducted with people to answer scientific questions. Clinical trials determine if scientific concepts can be turned into safe and effective therapies that make life better for people with Parkinson's.
We are very fortunate to have academic medical research institutes in the state of Alabama for people diagnosed with PD to have the opportunity to participate in clinical trials, studies and research. Therefore, choosing to work with a Movement Disorder Specialist can be key when choosing specialists to help you manage Parkinson's Symptoms. Movement Disorder Specialists are aware and can connect you to potential cutting-edge research and trials that can positively impact your PD journey. This also gives you an opportunity to give back and help clinicians make advancements for PD treatments and therapies.
There are various phases of Clinical Research and Drug and Device Research. They include:
Phase 1
Tests potential treatment for the first time in a small group of people to evaluate safety, determine the safe dosage and identify side effects.
Phase 2
Further evaluates the safety of the treatment being tested and provides preliminary measures of effectiveness.
Phase 3
Determines if the treatment benefits participants and if its benefits outweigh its risks.
Phase 4
After a drug or device is approved, this final phase of research can be conducted. Collects and looks over additional information about treatment, including risks, benefits and optimal use after FDA approval.
The entire process of bringing a new medication to the pharmacy can take up to 10 years from the time it is tested in a laboratory to the time that the doctor prescribes it as treatment. New research is investigating opportunities for Parkinson's in several areas:
Preventing or Slowing Parkinson's
Many researchers are looking at genetic and environmental causes of Parkinson's to see if they can identify targets for drugs that would help brain cells to fight the changes that cause Parkinson's. The goal is that anyone that is genetically predispositioned for Parkinson's could receive a treatment that might slow or prevent the disease.
Diagnosing PD and Measuring
Progression
Diagnosing Parkinson's is challenging, and usually doesn't happen currently until symptoms are well developed and dopamine is lost. Clinicians are working on areas to help diagnose the disease sooner so that more treatment options can be available prior to symptoms appearing. Some of the latest advancements include a skin-biopsy test that measures alpha-synuclein protein presence and imaging from a PET scan to measure alpha-synuclein presence in the brain for those living with PD.
Replacing Lost Function
It is a goal to create therapies that help the brain function like a healthy, normal brain. This could include therapies or treatments to help restore lost function. These clinicians are looking at all options, from surgery and therapies to devices and treatments.
Symptomatic Treatments
Research is ongoing to determine areas for managing "on-off" fluctuations, and reducing dyskinesia to achieve overall better motor control and symptom management. Additionally, researchers are looking to reduce side effects of current symptoms and treatments.
Therapeutic Treatments
In addition to drug and surgical treatments, researchers understand the importance of symptom management and disease progression when it comes to exercise and movement. Researchers are continuing to work toward discovering what types of exercises and therapies can be the most helpful for living a quality life with Parkinson's.
Available Trials and Research Studies
GO LOCAL
University of Alabama (UAB) - Department of Movement Disorders
The University of Alabama at Birmingham (UAB) has several ongoing clinical trials being conducted for Parkinson's. Speak with your Movement Disorder Specialist about the possibility of enrolling in a current clinical trial. To see the latest Clinical Trials being conducted by UAB for Parkinson's, CLICK HERE.
UAB - Black and African American Connections to Parkinson's Disease Study - Your Help is Needed!
The Global Parkinson's Genetics Program is hosting a study that will help researchers understand what Parkinson's disease looks like for Black and African American communities. You can participate in BLAAC PD at UAB who is seeking healthy controls for an observational study to help researchers understand what Parkinson's disease looks like for Black and African American communities. Black and African American people are valuable partners in research by helping us learn more about what causes disease or protects health in this community. Participation involves a one-time donation of saliva or blood. The visit will take less than 15 minutes and information is kept private and secure. Participants will be compensated $25 for their time. For more information, please contact Joseph Richardson at jhrichardson@uabmc.edu or 1.205.934.0074. You can learn more about the study that is part of the Global Parkinson's Genetic Program at www.parkinsonsroadmap.org/gp2
UAB - Study in Parkinson Disease of Exercise - Phase 3, Clinical Trial
Have you been diagnosed with Parkinson's disease within the past three years? If so, you may be eligible to participate in a new clinical trial study at UAB. The University of Alabama at Birmingham's Department of Physical Therapy is seeking volunteers to participate in a clinical research trial to learn more about the effects of aerobic exercise on people with Parkinson's disease. The Principal Investigator is Christopher Hurt, Ph.D. SPARX3 is a research study that will compare the effects of moderate intensity treadmill exercise to high intensity treadmill exercise on the signs and symptoms of Parkinson's disease. As a benefit of participating, you will receive information regarding your health status at no cost which includes a physical examination, blood and fitness tests, and exercise prescriptions. To be eligible, you must be between the ages of 40 to 80 years old, been diagnosed with PD within three years, not currently taking any PD medication or expect to start taking PD medications within the next six months, and be able and willing to do moderate to high intensity exercise on a treadmill four times a week for 18 - 24 months. For more information, please contact the study coordinator at 1.205.934.8517.
GO NATIONAL
Parkinson's Foundation - PD GENEration: Mapping the Future of Parkinson's Disease
This flagship study aims to provide free genetic testing and genetic counseling that will empower people with PD and their care team, improve Parkinson's care and research and accelerate enrollment in clinical trials. Through PD GENEration, the organization offers free genetic testing and genetic counseling to 15,000 people with PD in the U.S., beginning with the goal of enrolling 600 participants during the pilot period. PD GENEration is available to people with a confirmed diagnosis of PD, regardless of age, through participating in Centers of Excellence and Parkinson Study Group sites. To find out if your Center or site is participating, visit https://www.parkinson.org/advancing-research/join-study
Michael J. Fox Foundation - Parkinson's Progression Markers Initiative (PPMI)
Help researchers build a dynamic study to explore and better treat the spectrum of Parkinson's disease. PPMI has a particular need for people recently diagnosed with Parkinson's who are not yet taking PD medication. If this is you, please visit https://www.michaeljfox.org/your-impact-parkinsons-research to learn more and volunteer today. Enrolling people early in their disease allows the study to plot biology and experience from the earliest signs of Parkinson's through its later stages. The initiative is still following hundreds of its first participants, now more than 10 years from their diagnosis. These early volunteers have contributed to new tests and knowledge that may help diagnose disease and predict symptoms such as memory problems.
While PPMI is aiming to connect with people recently diagnosed and with certain risk factors, the study has opened to anyone over age 18 in the United States. Volunteers - with and without PD - can add to the study through its online platform, sharing information on health and disease over time. The more PPMI captures about brain health and aging, the faster science can move to cures. PPMI is making progress in its ambitious goals, but many more volunteers are needed. However, you have been touched by Parkinson's, you can make a difference.
Sources:
Davis Phinney Foundation for Parkinson's. Every Victory Counts, Your Go-To Resource of Essential Information and Inspiration for Living Well with Parkinson's. "Manual" Page 37. Sixth Edition, 2021.
Parkinson's Foundation: PD GENEration: Mapping the Future of Parkinson's Disease. https://www.parkinson.org/advancing-research/join-study. Accessed 12/1/2022.
Michael J. Fox Foundation - Parkinson's Progression Markers Initiative (PPMI) https://www.michaeljfox.org/your-impact-parkinsons-research Accessed 12/1/2022.
University of Alabama at Birmingham Clinical Trials Website: https://www.xpertdox.com/uab-trial/Parkinson's%20Disease?id=Parkinson%27s
Accessed 12/1/2022.