PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
United States4,500 participantsStarted 2020-07-01
Plain-language 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.
Who can participate
Age range30 Years
SexALL
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Inclusion criteria
â. Male or female age 57 years or older at Screening visit.
â. 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.
â. Confirmation that participant is eligible based on Screening SPECT imaging.
â. Able to provide informed consent.
â. Either is male, or is female and meets additional criteria below, as applicable:
Exclusion criteria
â. First degree relative with PD (i.e., biologic parent, sibling, child).
â. Current or active clinically significant neurological disorder (in the opinion of the Investigator).
â. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
â. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
â. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.
â. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
What they're measuring
1
Establish standardized protocols for acquisition, transfer and analysis of clinical, digital, imaging, biologic and genetic data that can be used by the PD research community.
Timeframe: Baseline to 156 months
2
Comprehensive and uniformly acquired dataset
Timeframe: Baseline to 156 months
3
Comparison between Rates of Change
Timeframe: Study intervals ranging from 3 months to 156 months
4
Prevalence of measures of clinical, imaging and biomic outcomes in various subsets
Timeframe: study intervals ranging from baseline to 156 months.
5
Establish the probability of phenoconversion to PD
Timeframe: study intervals ranging from baseline to 156 months.
Trial details
NCT IDNCT04477785
SponsorMichael J. Fox Foundation for Parkinson's Research