Parkinson's Trial NCT04477785
Identify signs to slow progression
- Trial ID
- NCT04477785
- Official Title
- The Parkinson's Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort
- Goal
- Identify signs to slow progression
- Status
- RECRUITING
- Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Study Type
- OBSERVATIONAL
- Enrollment
- 4500 participants
- Conditions
- Parkinson Disease
Summary For Families
The Parkinson's Progression Marker Initiative aims to find measurable signs that show how Parkinson's changes over time, so future treatments can be tested more quickly and accurately for slowing disability. Instead of testing a new therapy, it follows people over time and collects clinical exams, digital data from apps or devices, brain imaging such as a DaTscan, biological samples including spinal fluid, and genetic testing, with options for remote or app-based participation. They are enrolling several groups: people with early Parkinson's diagnosed within the last two years who are not yet on Parkinson's medications, people at higher risk or with early signs such as a reduced sense of smell, and healthy volunteers. Age guidelines are roughly 30 years and up for most Parkinson's groups, 57 and older for healthy controls, and 60 and older for most at-risk participants, and everyone must be willing to complete imaging, possible spinal fluid collection, and genetic testing when asked.
Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
- Barrow Neurological Institute, Phoenix, Arizona, United States
- Mayo Foundation for Medical Education and Research, Scottsdale, Arizona, United States
- Banner Research Institute, Sun City, Arizona, United States
- University of California San Diego, La Jolla, California, United States
- Keck School of Medicine of USC, Los Angeles, California, United States
- University of California, San Francisco, San Francisco, California, United States
- University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
- Institute For Neurodegenerative Disorders, New Haven, Connecticut, United States
- Parkinson's Disease& Movement Disorder Center of Boca Raton, Boca Raton, Florida, United States
- University of Florida, Gainesville, Florida, United States
- University of South Florida, Tampa, Florida, United States
- Emory University School of Medicine, Atlanta, Georgia, United States
- Northwestern University, Chicago, Illinois, United States
- University of Kansas Medical Center, Kansas City, Kansas, United States
- Johns Hopkins University, Baltimore, Maryland, United States
- Boston University, Boston, Massachusetts, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
- University of Michigan, Ann Arbor, Michigan, United States
- Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada, United States
And 30 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The Parkinson's Progression Marker Initiative aims to find measurable signs that show how Parkinson's changes over time, so future treatments can be tested more quickly and accurately for slowing disability. Instead of testing a new therapy, it follows people over time and collects clinical exams, digital data from apps or devices, brain imaging such as a DaTscan, biological samples including spinal fluid, and genetic testing, with options for remote or app-based participation. They are enrolling several groups: people with early Parkinson's diagnosed within the last two years who are not yet on Parkinson's medications, people at higher risk or with early signs such as a reduced sense of smell, and healthy volunteers. Age guidelines are roughly 30 years and up for most Parkinson's groups, 57 and older for healthy controls, and 60 and older for most at-risk participants, and everyone must be willing to complete imaging, possible spinal fluid collection, and genetic testing when asked.
- Who can participate?
- Participants must be at least 30 Years.
- Where is this trial located?
- This trial is recruiting at 50 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 13 years and 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.