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
This trial accepts healthy volunteersQualifiers
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 population
In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally from approximately 50-55 international clinical sites across a variety of cohorts, including healthy controls, Parkinson disease, PD manifesting gene carriers, and Prodromal (those at risk for developing PD).
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
4,500 Participants
are grouped into 1 trial groupGroup A: Clinical Observation
Trial outcomes
Primary outcomes
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.
This protocol will build on the existing PPMI infrastructure
Time frame
Baseline to 156 months2
Comprehensive and uniformly acquired dataset
Develop a comprehensive and uniformly acquired clinical, digital and imaging dataset and repository of biological and genetic samples that would be available to the PD research community to test hypotheses of the underlying molecular pathobiology of PD, enable modeling of PD progression to identify clinical and/or data driven PD progression sub-sets, and inform studies testing PD therapeutics (for examples, clinical trials targeting synuclein, LRRK2, GBA as well as other targets)
Time frame
Baseline to 156 months3
Comparison between Rates of Change
Use clinical and biological data to estimate the mean rates of change and the variability around the mean of clinical, digital, imaging, biological and genetic outcomes in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and individuals with prodromal Parkinson's disease (including individuals with REM sleep behavior disorder (RBD)), olfactory loss, LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without dopamine transporter (DAT) deficit and in healthy participants.
Time frame
Study intervals ranging from 3 months to 156 months4
Prevalence of measures of clinical, imaging and biomic outcomes in various subsets
Confirm existing and identify novel clinical, digital, imaging, biologic and genetic PD progression markers to identify quantitative individual measures or combinations of measures that demonstrate optimum interval change in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1)) and individuals with prodromal Parkinson's disease (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without DAT deficit in comparison to healthy controls or in sub-sets of study participants with PD diagnosis or prodromal PD defined by baseline assessments, progression milestones and/or rate of clinical, digital, imaging, biologic and genetic change, or other measures.
Time frame
study intervals ranging from baseline to 156 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael J. Fox Foundation for Parkinson's Research
Lead sponsor
Institute for Neurodegenerative Disorders
Sponsor institution
Institute for Neurodegenerative Disorders
Collaborator
Source ClinicalTrials.gov