PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorMichael J. Fox Foundation for Parkinson's Research
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
First degree relative with PD (i.e., biologic parent, sibling, child).
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
4,500 Participants
are grouped into 1 trial groupSponsors and collaborators
Michael J. Fox Foundation for Parkinson's Research
Lead sponsor
Institute for Neurodegenerative Disorders
Sponsor institution
Institute for Neurodegenerative Disorders
Collaborator
Source ClinicalTrials.gov