PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
- Conditions
- Parkinson Disease
- Registration Number
- NCT04477785
- Lead Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Brief 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.
- Detailed Description
PPMI is a broad program, expanding the goals of the original PPMI study, that includes this PPMI Clinical protocol, as well as other program initiatives such as the PPMI Remote, PPMI Digital App and PPMI Online protocols. Participants in PPMI may be asked to be enrolled in other PPMI program protocols, but depending on their method of recruitment, participants may be enrolled sequentially in varying order, as appropriate. PPMI participants may also be asked to participate in additional PPMI program initiatives (as they are developed), which may only involve a subset of PPMI participants based on their cohort designation and/or site location.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison between Rates of Change Study intervals ranging from 3 months to 156 months 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.
Establish the probability of phenoconversion to PD study intervals ranging from baseline to 156 months. Evaluate the probability of phenoconversion to PD for individuals with prodromal PD enrolled in the prodromal cohorts (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).
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. Baseline to 156 months This protocol will build on the existing PPMI infrastructure
Comprehensive and uniformly acquired dataset Baseline to 156 months 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)
Prevalence of measures of clinical, imaging and biomic outcomes in various subsets study intervals ranging from baseline to 156 months. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Mayo Foundation for Medical Education and Research
🇺🇸Scottsdale, Arizona, United States
Banner Research Institute
🇺🇸Sun City, Arizona, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Paracelsus-Elena Klinik
🇩🇪Kassel, Germany
University of Luebeck
🇩🇪Luebeck, Germany
University of Tuebingen
🇩🇪Tuebingen, Germany
Foundation for Biomedical Research of the Academy of Athens
🇬🇷Athens, Greece
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Radboud University
🇳🇱Nijmegen, Gelderland, Netherlands
Lagos College of Medicine, University of Lagos
🇳🇬Lagos, Nigeria
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
University of Salerno
🇮🇹Salerno, Italy
Parkinson Research Clinic
🇱🇺Luxembourg, Luxembourg
NYU Langone Health
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Cincinnati/Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Oregon Health &Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Donostia
🇪🇸San Sebastian, Spain
Queen Mary University of London
🇬🇧London, Britain, United Kingdom
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Institute For Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Parkinson's Disease& Movement Disorder Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Boston University
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Univ of Washington and VA Puget Sound Health Care System
🇺🇸Seattle, Washington, United States
Innsbruck Medical University
🇦🇹Innsbruck, Austria
The Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
McGill University
🇨🇦Montréal, Quebec, Canada
Philipps-University of Marburg
🇩🇪Hessen, Germany
Newcastle University
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Imperial College London
🇬🇧London, United Kingdom
John Radcliffe Hospital Oxford and Oxford University
🇬🇧Oxford, United Kingdom