PPMI 2.0
Research type
Research Study
Full title
The Parkinson’s Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort
IRAS ID
285735
Contact name
Nicola Pavese
Contact email
Sponsor organisation
MJF Foundation
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
10 years, 4 months, 22 days
Research summary
PPMI2.0 is a broad program, expanding the goals of the original PPMI study that was started in 2010 and has recruited 424 patients with Parkinson's disease (PD), 196 healthy controls, 600 patients with genetic mutations linked to PD, and 65 prodromal participants. The PPMI study has made substantial progresses in PD research with more than 170 publications and 2 million downloads of PPMI data for research purposes worldwide. However, there is a consensus that a new PPMI cohort is necessary to further develop and validate biomarkers for PD progression and prodromal PD to enable therapeutic development, Further advances in molecular genetics, neurobiology, imaging technology, wearable sensor and remote assessment technology and radiochemistry have provided new tools that may be useful in identification of such biomarkers for further studies of therapies that may slow or prevent PD disability. PPMI2.0 is therefore a longitudinal, observational, multi-centre natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of PD progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI2.0 is to identify markers of disease progression for the use in clinical trials of therapies to reduce progression of PD disability.
To accomplish this primary objective the study investigtors will:
a. Establish standardized protocols for acquisition, transfer and analysis of clinical, imaging and biological data that can be used by the PD research community.
b. Develop a comprehensive and uniformly acquired clinical and imaging dataset and biological samples that can be used to estimate the rates of disease change and their variability in PD patients.
c. Validate existing and identify novel clinical, imaging, and biological Parkinson disease progression markers that robustly demonstrate change in PD patients in comparison to healthy controls.
d. Conduct preliminary validation studies on promising biological markers using stored collected samples.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0900
Date of REC Opinion
7 Sep 2020
REC opinion
Further Information Favourable Opinion