Identify tests predicting Parkinson progression
- Trial ID
- NCT04477785
- Official Title
- The Parkinson's Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort
- Goal
- Identify tests predicting Parkinson 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 goal is to identify imaging, genetic, fluid, and clinical markers that track and predict Parkinson's progression so we can diagnose earlier and design better, more targeted trials. Instead of testing a drug, the study deeply profiles participants with DaTscan SPECT to measure dopamine transporter loss, genetic testing for LRRK2/GBA/SNCA and other variants, lumbar punctures for CSF biomarkers (like alpha-synuclein), MRI, and repeated clinical and remote assessments; DAT imaging is used for eligibility but results are not revealed to participant or site. They are looking for several groups: healthy controls age 57 and up, people with early PD diagnosed within 2 years who are generally not yet on levodopa or other PD meds (age 30+), genetic-subtype PD cases, and prodromal high-risk adults (typically 60+), with common exclusions for dementia, recent dopamine-blocking drugs, anticoagulation or any condition that would make lumbar puncture unsafe.
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 goal is to identify imaging, genetic, fluid, and clinical markers that track and predict Parkinson's progression so we can diagnose earlier and design better, more targeted trials. Instead of testing a drug, the study deeply profiles participants with DaTscan SPECT to measure dopamine transporter loss, genetic testing for LRRK2/GBA/SNCA and other variants, lumbar punctures for CSF biomarkers (like alpha-synuclein), MRI, and repeated clinical and remote assessments; DAT imaging is used for eligibility but results are not revealed to participant or site. They are looking for several groups: healthy controls age 57 and up, people with early PD diagnosed within 2 years who are generally not yet on levodopa or other PD meds (age 30+), genetic-subtype PD cases, and prodromal high-risk adults (typically 60+), with common exclusions for dementia, recent dopamine-blocking drugs, anticoagulation or any condition that would make lumbar puncture unsafe.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 13 years and 5 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.