Sub Studies
PPMI sub studies are add-on studies designed to align with the scientific goals and be within the work scope of the PPMI Clinical study. These studies include new data collection from all or a subset of PPMI sites and participants enrolled in PPMI Clinical. All data and samples collected from these studies will be included in the data repository and biorepository available by requesting access to the information through the PPMI Data & Specimens pages.
Sub Studies Protocols and Manuals
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Protocols and CRFs
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| Active - not recruiting. Estimated completion date June 2025 |
PPMI Early Imaging Protocol v3.1 Early Imaging CRF |
Title: Early Longitudinal Imaging in Parkinson’s Progression Markers Initiative Using [18F] AV-133 and DaTscanTM (PPMI Early Imaging) Principal Investigator: Kenneth Marek, MD Objectives: The current study is a longitudinal, multi-center study to assess progression of DaTscan and [ 18F] AV-133 imaging in PD and Prodromal pa. Participants will be followed for up to 24 months. Approximately 50 early PD participants and 100 Prodromal participants will be recruited from up to 15 sites. All participants will be comprehensively assessed at baseline and every six months thereafter based on respective cohort. Participants will undergo imaging assessments with DaTscan and [ 18F] AV-133, clinical (motor, neuropsychiatric and cognitive) assessments. Data will be collected by each site under uniformly established protocols and data will be stored and analyzed at designated core facilities. Study Population: Approximately 150 participants will be enrolled in this companion study. Approximately 50 PD participants and 100 Prodromal participants will be recruited from up to 15 sites. |
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Protocols and CRFs
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| Closed |
PPMI Tau PET Imaging Protocol Tau Imaging CRF |
Title: Assessment of Brain Tau Burden in Participants with Parkinson Disease in the PPMI Study (PPMI Tau PET Imaging) Principal Investigator: Kenneth Marek, MD Objectives: The primary goal of this imaging study is to test whether positron emission tomography (PET) with PI-2620 can visualize in vivo brain tau deposition in participants with Parkinson’s disease (PD). The secondary goal is to evaluate tau deposition in PD LRRK2 mutation carriers given recent data that tau pathology may be present in those individuals. Study Population: Approximately 35 participants enrolled in the PPMI study will be recruited, including approximately 10 individuals with LRRK2 mutations (LRRK2, manifest or non-manifest), 20 sporadic PD individuals (across a range of disease duration from newly diagnosed to longstanding PD) and 5 healthy controls. |
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Protocols and CRFs
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| Recruiting |
Gait Protocol v1.2 Gait CRF |
Title: Mobility and Gait Markers of Disease and Disease Progression (PPMI Gait) Principal Investigator: Anat Mirelman, PhD Objective: The primary objective of this study is to assess whether Digital Health Technology (DHT) can enrich the identification of individuals at risk of developing PD. The secondary objectives of this study are to explore whether DHT measures are sensitive to progression (prodromal and early stages of PD) and, to explore clinometric parameters (sensitivity and specificity) of different measures from different applications (Roche app, Axivity, Opals) and identify the ones with greatest yield in assessing motor and non-motor features. Study population: Approximately 300 participants enrolled in the PPMI Clinical will be recruited, including 200 prodromal participants, 50 participants recently diagnosed with PD, and 50 healthy controls. |
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Protocols and CRFs
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| Active | Whole Blood T cells Protocol v1.0 |
Title: Autoimmunity and the role of T cells in PD Principal Investigator: David Sulzer, PhD; Cecilia Arlehamn, PhD Objective: To determine changes in epitope-specific T cell reactivity against proteins for which processing is altered in neurodegenerative diseases including PD such as a-syn (including fibrils, which activate T cells 1), tau, amyloid-b and amyloid precursor protein, optineurin, GBA, LRRK2, TDP-43, OGDH, dysbindin, and ataxins. Study population: Approximately 180 participants: Prodromal n=120 (RBD (REM Behavior Disorder) 60; Hyposmic 60), PD n=30, HC (Healthy Control) n=30. |
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| Recruiting |
SV2A PET Imaging Protocol v1.0 SV2A PET Imaging CRF |
Title: Longitudinal [18F]SynVesT-1 PET targeting SV2A in PPMI Principal Investigator: Kenneth Marek, MD Objective: The primary study outcome will be the regional brain binding of [ 18F]SynVesT-1 PET imaging assessment of brain synaptic density at baseline and annually for 24 months. Study population: Participants will be recruited until a total of up to 50 Prodromal and manifest (PD) participants, and 10 healthy participants have completed an evaluable baseline [ 18F]SynVesT-1 imaging. |
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Protocols and CRFs
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| Recruiting |
AV-133 Prodromal Imaging Protocol v1.1 AV-133 Prodromal Imaging CRF |
Title: Early Longitudinal Imaging in the Parkinson’s Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging) Principal Investigator: Kenneth Marek, MD Objective: Primary objective is to estimate the mean rates of change and the variability around the mean of [18F] AV-133 imaging outcomes in individuals with Prodromal Parkinson’s disease, and where appropriate the comparison of these rates between patient subsets at study intervals ranging from 12 months to 24 months. Prodromal subsets may be defined by baseline assessments, genetic mutation, progression milestones and/or rate of clinical, imaging, or biomic change. Study Population: Approximately 100 Prodromal PD participants will be recruited from up to 10 sites in North America, Europe, and Israel. |
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Submit a Sub Study
Sub study submissions are reviewed on an ongoing basis by the PPMI Sub Study Committee, chaired by Kalpana Merchant, Ph.D., and Kathleen Poston, M.D.