PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort

What this study is about

The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Who can join (things the study team will check)

7.1 Healthy Controls (HC) Note: Active Healthy controls previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy). 7.1.1 Inclusion Criteria (HC) 1. Male or female age 57 years or older at Screening visit. 2. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging. 3. Confirmation that participant is eligible based on Screening SPECT imaging. 4. Able to provide informed consent. 5. Either is male, or is female and meets additional criteria below, as applicable: * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM. 7.1.2 Exclusion Criteria (HC) 1. First degree relative with PD (i.e., biologic parent, sibling, child). 2. Current or active clinica…

Where this trial is running

• 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

+ 38 more sites.

Who to contact

Cari Rainville, BS · 877-525-7764 · crainville@indd.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04477785.