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PPMI Clinical: Understanding Parkinson's Disease Progression

This is an observational study called the Parkinson Progression Marker Initiative (PPMI) Clinical, which aims to better understand how Parkinson's disease (PD) progresses over time. Researchers will collect information from people with PD, those who might be developing PD (prodromal PD), and healthy volunteers. The goal is to establish clear ways to collect and analyze clinical information, digital data, brain scans, biological samples, and genetic information. This will help the research community find markers that show how PD changes, which can then be used to test new treatments in future clinical trials. This study plans to enroll 4500 participants and will follow them for up to 156 months (about 13 years). The study is currently ongoing, but its exact status is unclear.

Study design
This is an observational study, meaning participants will be monitored over time without receiving any specific experimental treatment. It aims to enroll 4500 participants, including people with Parkinson's disease, those with prodromal Parkinson's, and healthy controls.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 156 months (about 13 years) to track changes over time.

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NCT04477785

PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort

Recruiting
Not specifiedAges 30+Observational
Michael J. Fox Foundation for Parkinson's Research
~4,500 participants
Updated 2026-07-27 on ClinicalTrials.gov

At a glance

Recruiting sites
50 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Baseline to 156 months
+4 more outcomes measured

Conditions

Parkinson Disease

Explore related trials

HealthyParkinson DiseaseProdromal Parkinson DiseaseAlpha-SynucleinE3 Ubiquitin-Protein Ligase ParkinGBA1 GeneLRRK2 GenePINK1 Gene

NCT04477785

Where you'd take part

This study runs at 50 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner Research Institute

    Sun City, Arizonastudy coordinator listed

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Baylor College of Medicine

    Houston, Texasstudy coordinator listed

    Recruiting

  • Beth Israel Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Boston University

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevadastudy coordinator listed

    Recruiting

  • Emory University School of Medicine

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kenneth L Marek, MD · PRINCIPAL_INVESTIGATOR · Institute for Neurodegenerative Disorders
  • Caroline Tanner, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Cari Rainville, BS
[email protected]
877-525-7764
Email the study team

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Eligibility criteria

Inclusion

Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.
Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.
Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.
Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.
For participants in PPMI Remote, referral to the clinical site confirms predictive eligibility.
For participants identified by the clinical site, predictive criteria are based on generalized risk such as first degree biologic relative, known risk of PD including RBD, or known genetic variants associated with PD risk.
Screening SPECT Imaging eligibility:
It is anticipated that approximately 6,000 participants will complete a screening visit to undergo DAT imaging. Approximately 2,000 participants will be eligible to continue their participation in PPMI Clinical (those not eligible to proceed will remain in PPMI Remote, as applicable).
All participants with DAT deficit will be eligible to continue their participation in PPMI Clinical. It is estimated that about 75% of eligible participants will have a DAT deficit (defined by a hybrid of visual assessment and quantitative striatal specific binding analysis).
Some participants without DAT deficit will also be eligible to continue their participation in PPMI Clinical. These participants will be chosen based on DAT binding that is reduced from age expected but it not outside the normal range and/or from individuals with high-risk of PD including RBD, LRRK2, GBA, SNCA, or rare genetic variants (such as Parkin or Pink1) that do not demonstrate DAT deficit. It is estimated that about 25% of eligible participants will not have a DAT deficit.
It is anticipated that approximately 30% of the PPMI Clinical prodromal participants with DAT deficit will phenoconvert to motor parkinsonism during a 3 to 5-year follow-up.

What this trial measures

  • 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 datasetBaseline 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)

  • Comparison between Rates of ChangeStudy 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.

  • Prevalence of measures of clinical, imaging and biomic outcomes in various subsetsstudy 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.

  • Establish the probability of phenoconversion to PDstudy 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).