Study Cohorts
The Parkinson’s Progression Markers Initiative (PPMI) Clinical study has enrolled people diagnosed with Parkinson’s disease, people with prodromal Parkinson’s disease, and healthy controls as the primary cohorts. Below we detail the eligibility criteria at enrollment.
PPMI began initial recruitment in 2010. Over time, there have been differences in the protocol, eligibility criteria, and schedule of activities. Previous protocols are available under the Research & SOPs section for review.
All PPMI participants are also assigned to cohorts and subgroups based on biomarker data collected after enrollment. Defining groups based on subgroups, as opposed to enrollment cohort, may be more appropriate for certain analyses. These subgroups and their definitions are provided in the Curated Data Cut which is available in the data repository (Access Data | Parkinson's Progression Markers Initiative). Also see the Groups and Subgroups Guidance Document on the Data Resources page (Guidance Resources | Parkinson's Progression Markers Initiative) for suggested analytic groups in the Prodromal Cohort.
See below for the recruitment status of each cohort.
Parkinson's Disease
Participants with Parkinson's disease, with and without genetic risk variants.
LEARN MOREProdromal Cohort
Participants who are at risk of Parkinson’s or another parkinsonism based on clinical features, genetic variants, or other biomarkers.
LEARN MOREHealthy Controls
Participants with no neurologic disorder and no first degree relative with PD.
LEARN MORELegacy Cohorts
Some initial-phase PPMI cohorts are not restarting recruitment. Their data is available, and some continue study participation.
LEARN MOREParkinson’s Disease
Participants with diagnosed Parkinson’s disease
All participants of the PD cohort have a clinical diagnosis of PD. The PD cohort is comprised of several subgroups, which include the following key inclusion criteria:
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People with untreated PD1:
The initial phase of PPMI enrolled 423 untreated PD participants. Many of these participants continue in PPMI, and the study has enrolled an additional 600 sporadic untreated PD study participants.
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People with PD and pathogenic genetic variant(s):
The initial phase of PPMI enrolled 294 genetic PD participants with SNCA, LRRK2 and/or GBA variants. Many of these participants continue in PPMI, and the current recruitment expansion aims to enroll additional PD participants with pathogenic genetic variants including rare genetic variants such as Parkin, PINK1.
For participants with LRRK2, GBA variants
Initial Stage Expansion Stage Minimum age 18 30 Years since diagnosis Within 7 years Any number of years4 Hoehn and Yahr at Baseline I, II, or III Any stage4 Medications for PD Initiated? Allowed Allowed For participants with rare genetic variants
Initial Stage Expansion Stage Minimum age 18 30 Years since diagnosis Within 7 years No Limit Hoehn and Yahr at Baseline I, II, or III I, II, or III Medications for PD Initiated? Allowed Allowed
Please see the Protocol and Protocol Clarification Letters posted on the Research Documents & SOPs page for full inclusion and exclusion criteria.
Footnotes:
- Because some PD participants were enrolled as early as 2010, most from the initial recruitment phase are now receiving treatment and have established motor fluctuations and/or dyskinesia.
- A small number of individuals in the PD cohort were initially recruited into the SWEDD cohort of PPMI (see Legacy Cohorts), but later on developed PD and are now enrolled in the PD cohort of the study.
- In a few instances, exceptions were made allowing recruitment of individuals with longer disease duration
- Please see current and former Protocols and Protocol Clarification Letters posted on the Research Documents & SOPs page as these criteria have changed over time.
Prodromal Cohort
Participants who are at risk of Parkinson’s based on clinical features, genetic variants, or other biomarkers.
Early recruitment periods enrolled 67 participants with REM sleep behavior disorder (RBD) and/or hyposmia and DAT deficit and 445 participants with a genetic risk variant (SNCA, LRRK2, GBA). Many of these participants continue in PPMI, and the expansion phase aims to enroll additional prodromal participants.
The study is currently recruiting based on Amendment 4 to the protocol, and inclusion criteria are as follows:
- Age 40 or older
- Exception: Age 30 years or older for SNCA or rare genetic variants (e.g., PRKN, PINK1)
- No clinical diagnosis of PD or other parkinsonism or of dementia
- Either:
- Hyposmia based on University of Pennsylvania Smell Identification Test and alpha-synuclein seed amplification assay (aSyn SAA) confirmed status.
- SNCA or other rare genetic variants
Please see the Protocol on the Research Documents & SOPs page for full inclusion and exclusion criteria.
Related links
Healthy Controls
Participants with no neurologic disorder and no first-degree relative with PD.
At baseline, healthy controls have no current or active clinically significant neurological disorder, no first-degree relative with PD, and normal dopamine transporter (DAT) SPECT imaging by visual inspection.
The initial phase of PPMI recruited 196 control volunteers. Many of these participants continue in PPMI, and the expansion phase aims to recruit an additional 100 healthy controls.
Please see the Protocol on the Research Documents & SOPs page for full inclusion and exclusion criteria. Please make note of differences in inclusion/exclusion criteria for the initial and expansion phases. For example, in the initial phase of recruitment, an exclusion criterion for the healthy control cohort was a Montreal Cognitive Assessment score of ≤26. This criterion is not present in the expansion phase.
Related links
Legacy Cohorts
Two cohorts from the PPMI initial stage will not reopen recruitment in the expansion phase.
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The Genetic Registry
This cohort recruited people with a pathogenic genetic risk variant (LRRK2, GBA, SNCA) either diagnosed Parkinson’s disease (PD) or unaffected. The schedule of activities and duration of follow-up for the Genetic Registry differed from that of the PD and Prodromal Cohorts (see archived Research Documents & SOPs for more details).Some Genetic Registry participants were invited to transition to the PD or the Prodromal Cohort. Any transitioned participants will follow the SOA for the active protocol.
Related links
| EVENT_ID | SC/BL | V03 | V04 | V05 | V06 | V07 | V08 | V09 | V10 | V11 | V12 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Months | SC/BL | 6* | 12* | 18* | 24 | 30* | 36* | 42* | 48 | 54* | 60* |
*Phone visits
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Scan without dopaminergic deficit (SWEDD)
This cohort included participants who were clinically diagnosed with PD but had a normal DAT SPECT on visual inspection. A small number of SWEDD individuals continue to participate in longitudinal follow-up.In the expansion phase, newly recruited participants will not be eligible if the DAT SPECT is normal (with some exceptions noted in the protocol).
EVENT_ID | SC | BL | V01 | V02 | V03 | V04 | V05 | V06 | V07 | V08 | V09 | V10 | V11 | V12 | V13 | V14 | V15 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Months | SC | BL | 3 | 6 | 9 | 12 | 18 | 24 | 30 | 36 | 42 | 48 | 54 | 60 | 72 | 84 | 96 |
| Participants | 81 | 66 | 57 | 53 | 56 | 57 | 58 | 56 | 1 | 1 | 3 | 2 | 3 | 3 | 3 | 3 | 3 |
Resources
Our user guidance resources describe PPMI data, covering variable and schema definitions, values, and more instructional materials.
The study’s data and biosample collection, storage and analysis methods have become field-wide standards.
This interactive tool provides an aggregate-level snapshot of PPMI cohort demographics and data collection time points.