Trial Summary
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.
Sponsor: Michael J. Fox Foundation for Parkinson's Research
Participants: ALL
Start: 2020-07-01
Completion: 2033-12
Min Age: 30 Years
Eligibility Criteria
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 clinically significant neurological disorder (in the opinion of the Investigator). 3. Previously obtained MRI scan with evidence of clinically…
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.