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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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. How to cite: Kenneth Marek 2024. Early Longitudinal Imaging in Parkinson’s Progression Markers Initiative Using [18F] AV-133 and DaTscanTM (PPMI Early Imaging). protocols.io https://dx.doi.org/10.17504/protocols.io.5jyl825j6l2w/v1 |
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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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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. How to cite: Anat Mirelman, PhD 2024. Mobility and Gait Markers of Disease and Disease Progression (PPMI Gait). protocols.io https://dx.doi.org/10.17504/protocols.io.dm6gpzrr1lzp/v1 |
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| Completed | 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. How to cite: David Sulzer, Cecilia Arlehamn 2024. Autoimmunity and The Role of T Cells in Parkinson’s Disease (PPMI Whole Blood T cells). protocols.io https://dx.doi.org/10.17504/protocols.io.261ge543jg47/v1 |
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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. How to cite: Kenneth Marek 2024. Longitudinal [18F]SynVesT-1 PET targeting SV2A in PPMI (PPMI SV2A PET Imaging). protocols.io https://dx.doi.org/10.17504/protocols.io.eq2lywp9evx9/v1 |
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PPMI_015_AV-133 Prodromal Imaging Protocol v2.0_20 US Version PPMI 015 AV-133 Prodromal Imaging-CA,UK,IS Protocol V1.2_13 PPMI 015 AV-133 Prodromal Imaging-EU Protocol V1.1_13 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 biomarker change. Study Population: Approximately 100 Prodromal PD participants will be recruited from up to 10 sites in North America, Europe, and Israel. How to cite: Kenneth Marek 2024. Early Longitudinal Imaging in the Parkinson’s Progression Markers Initiative Using [ 18F] AV-133 (PPMI AV-133 Prodromal Imaging). protocols.io https://dx.doi.org/10.17504/protocols.io.bp2l62nqkgqe/v1 |
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| Completed | C05-05 PET Imaging Protocol v1.1 |
Title: Assessment of [18F] C05-05 PET Imaging in Participants with Parkinson’s Disease in the PPMI Study Principal Investigator: Kenneth Marek, MD Objective: The overall goal of this protocol is to investigate [18F] C05-05 PET imaging, targeting alpha synuclein, binding in brain regions, in Parkinson’s Disease (PD) participants and healthy volunteers participating in the PPMI study. Study Population: Approximately 10 participants enrolled in the PPMI study will be recruited, including approximately 5 participants with PD and 5 healthy participants. How to cite: Kenneth Marek 2024. Assessment of [18F] C05-05 PET Imaging in Participants with Parkinson’s Disease in the PPMI Study (PPMI C05-05 PET Imaging). protocols.io https://dx.doi.org/10.17504/protocols.io.eq2lyw3ymvx9/v1 |
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DPA-714 PET Imaging Protocol v1.1. DPA-714 PET Imaging CRF |
Title: Longitudinal TSPO PET imaging with [18F]DPA-714 in PPMI Principal Investigator: David Standaert, MD. Objective: The overall goal of this protocol is to investigate [18F]DPA-714 binding in prodromal and early manifest Parkinson’s Disease (PD) and to determine the baseline and change from baseline in [18F]DPA-714 binding in PD participants during a 24-month interval. 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]DPA-714. Note that the baseline [18F]DPA-714 may occur at any PPMI study visit. How to cite: DPA-714 PET Imaging: David Standaert 2024. Longitudinal TSPO PET imaging with [18F] DPA-714 in PPMI (PPMI DPA-714 PET Imaging). protocols.io https://dx.doi.org/10.17504/protocols.io.x54v92mxql3e/v1 |
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029Protocol_NXPI2620PD_12June2025_Final PPMI (NX PI-2620 Tau Imaging Substudy) Adverse Event In-Clinic Assessment v0.91 2025-04-17 PPMI (NX PI-2620 Tau Imaging Substudy) Adverse Event Telephone Assessment v0.9 2025-04-01 PPMI (NX PI-2620 Tau Imaging Substudy) Conclusion of Study Participation v0.91 2025-04-23 PPMI (NX PI-2620 Tau Imaging Substudy) Documentation of Informed Consent v0.9 2025-04-01 PPMI (NX PI-2620 Tau Imaging Substudy) Inclusion Exclusion Criteria_v0.91 2025-04-03 PPMI (NX PI-2620 Tau Imaging Substudy) PI-2620 Imaging v0.9 2024-04-02 PPMI (NX PI-2620 Tau Imaging Substudy) Pregnancy Test v0.9 2025-04-01 PPMI (NX PI-2620 Tau Imaging Substudy) Report of Pregnancy v0.9 2025-04-01 PPMI (NX PI-2620 Tau Imaging Substudy) Screen Fail v0.9 2025-04-02 |
Title: Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson’s Disease Using [18F]PI-2620: A High-resolution PET Imaging Study Using NeuroEXPLORER (NX PI-2160 in PD) Principal Investigator: Neha Prakash, MBBS Objective: The primary objective is to investigate in vivo tau deposition in sporadic and LRRK2 Parkinson’s disease (PD) compared to taupathies and healthy individuals using the NeuroEXPLORER (NX) positron emission tomography (PET) and [18F]PI-2620. Study Population: Approximately 60 participants will be enrolled into the study. Around 20 sporadic PD, 20 LRRK2 PD, and 10 healthy control participants will be enrolled from the PPMI clinical study. Around 10 participants with either PSP or CBS will be enrolled from the general population. |
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022_ConcernsForPDSurvey_V1_13June2024_en_US 022_HealthBehaviorSurvey_V1_13June2024_en_US 022_HIQ Survey_V1_13June2024_en_US 022_PerspectivesOnFutureSurvey_V1_13June2024_en_US 022_Protocol_V1_17June2024_US |
Title: PPMI Randomized Disclosure Assessment in the Parkinson's At Risk Cohort: The RaDAR Study Principal Investigator: Thomas F Tropea, DO Objective- The primary objective is to evaluate differences in exercise, diet, lifestyle changes, clinical trial enrollment, change in research and clinical diagnosis, retention in the delayed disclosure arm, and retention in PPMI Clinical study between individuals with prodromal PD symptoms who learn their research information at immediate (following consent) versus delayed (2 years following consent to RADAR study) timepoints. Study Population - This study will include people with prodromal symptoms of synucleinopathy (genetic risk variant carrier, REM sleep behavior disorder, and/or hyposmia) enrolled in the Parkinson Progression Markers Initiative (PPMI) Clinical prodromal cohort who are registered on myPPMI. |
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PPMI 030 Dual PET AV133 in Prodromal PD Protocol v1.0_16 Dual PET AV-133 Prodromal CRF |
Title: A Comparative Performance Study between High and Standard Resolution Positron Emission Tomography Camera using [18F]AV-133 in Prodromal Parkinson's Disease [Dual PET AV133 in Prodromal PD] Principal Investigator: Neha Prakash, MBBS. Objective:To compare [18F]AV133 binding acquired in the NX and Siemens Biograph PET in both striatal regions and potentially additional relevant regions including midbrain (substantia nigra), pons (locus coeruleus), and raphe nuclei in all participants. Study Population:The study will recruit the Prodromal participants enrolled in the PPMI 015 sub study. Approximately 25 participants will be enrolled at the INDD site. |
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027_LITE Protocol_V2.0_26Aug2025_en_US |
Title: The MJFF LRRK2 Investigative Therapeutics Exchange (LITE) Study U.S. Principal Investigator: Thomas Tropea, DO Objective:The overall aim of the LITE study is to identify critical biological markers for LRRK2-driven PD. The LITE study objectives are: (i) collect relevant biological samples, clinical and other data from a large and diverse cohort of carriers of variants in relevant genes (including but not limited to LRRK2, VPS35, Rab32, GBA) with and without PD, people with idiopathic PD, healthy controls and at-risk individuals. (ii) deploy novel organelle enrichment strategies (e.g. tagless LysoIP) and other markers for LRRK2 kinase activation and lysosomal dysfunction and correlate these with markers of pathological α-synuclein aggregation in blood and CSF as part of the core analysis. (iii) undertake explorative biomarker discovery research using skin biopsies, skin sebum, and breath. (iv) perform sophisticated untargeted and targeted mass-spectrometry and other analysis in all available biological specimens and analysis thereof that will be made available to the PD research community. (v) establish a clinical trial-ready cohort of patients with LRRK2-driven PD. Study Population: Approximately 1000 participants globally, with a goal of 200 participants in the U.S.. All participants will be recruited from individuals already enrolled in the PPMI Clinical (002) study who meet the eligibility criteria for this study. |
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020_Symptom Map_example PPMI020_Mapping Symptoms_survey PPMI020_PPMI Mapping Symptoms Protocol v1.0_22Mar2024 |
Title: PPMI Mapping Meaningful Symptoms and Impacts in People with Prodromal Parkinson’s Disease (PPMI Mapping Symptoms) Principal Investigator: Jamie Adams, MD & Jennifer Mammen, PhD Objective:To evaluate patient-perceived potential symptoms of prodromal PD/DLB that are meaningful and personal impacts of symptoms, if any. This cross-sectional study will: (A) Identify and characterize potential symptoms of earliest PD/DLB. Potential symptoms are defined as any changes from personal normal/baseline in the past 5 years; (B) Evaluate personal meaningfulness of symptoms with classification of present/bothersome vs. important; and (C) Explore actual and anticipated functional and psychological impacts of potential symptoms. Study Population:This study includes people with and without prodromal PD/DLB who are also participating in PPMI. We expect to enroll up to 100 participants, approximately 40-50 with prodromal PD/DLB and 40-50 healthy controls (no neurologic disorder and no first degree relative with PD) |
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018_PDMedicationsQuestionnaire_US_v2.0_29Aug2024_en_US_final 018_Questionnaire1_US_v1.0_11July2024_en_US 018_Session Follow-up Survey_US_v4.0_en_US_12-Dec-2024_Final clean Protocol_PPMI018_Cognitive Activities_v1.0_08March2024_Final |
Title: Parkinson’s Progression Markers Initiative Cognitive Activities (PPMI Cognitive Activities) Principal Investigator: Caroline M Tanner, MD PhD Objective:The primary objective of PPMI Cognitive Activities is to assess the feasibility of web-based cognitive testing in people with and without PD and how the results relate to other data collected in the PPMI program. Study Population:This study will include people with and without PD who are also participating in PPMI. During the course of this study, we expect to enroll up to 100,000 participants globally, starting with the US for the initial phase. |
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023_SynOne_Protocol_US_final_07OCT2024_en_US PPMISynOneCRF_v09Sep2025 |
Title: SynOne Pilot Project Principal Investigator: Ken Marek, MD Objective:The primary objective of this study is to determine the sensitivity and specificity of the SynOne skin test for CSF asyn SAA in PPMI participants (Neuronal synuclein disease (NSD)+ and NSD-). Study Population:50 participants enrolled in PPMI based on SAA status and other inclusion/exclusion |
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Dual PET AV-133 PD rotocol Dual PET AV-133 PD Imaging Substudy CRF |
Title: A Comparative Performance Study between High and Standard Resolution Positron Emission Tomography Camera using [18F]AV-133 in Parkinson’s Disease [Dual PET AV-133 in PD] Principal Investigator: Neha Prakash, MBBS. Objective:To compare the longitudinal change in [18F]AV-133 binding acquired with the NX to Siemen’s Biograph PET in individuals with Parkinson’s disease (PD) over a period of 1 year. Study Population:Approximately 45 PD participants, and 5 Healthy Control Participants will be recruited from individuals already enrolled in the PPMI Clinical (002) study who meet the eligibility criteria for this imaging sub-study. |
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.