PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
United States, Austria, Canada4,500 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 range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female age 57 years or older at Screening visit.
. 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.
. Confirmation that participant is eligible based on Screening SPECT imaging.
. Able to provide informed consent.
. Either is male, or is female and meets additional criteria below, as applicable:
Exclusion criteria
. First degree relative with PD (i.e., biologic parent, sibling, child).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Current or active clinically significant neurological disorder (in the opinion of the Investigator).
. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.
. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.