PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort (PPMI)

June 10, 2026 updated by: Ken Marek, MD, Michael J. Fox Foundation for Parkinson's Research

The Parkinson's Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort

The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls.

The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Study Overview

Status

Recruiting

Conditions

Detailed Description

PPMI is a broad program, expanding the goals of the original PPMI study, that includes this PPMI Clinical protocol, as well as other program initiatives such as the PPMI Remote, PPMI Digital App and PPMI Online protocols. Participants in PPMI may be asked to be enrolled in other PPMI program protocols, but depending on their method of recruitment, participants may be enrolled sequentially in varying order, as appropriate. PPMI participants may also be asked to participate in additional PPMI program initiatives (as they are developed), which may only involve a subset of PPMI participants based on their cohort designation and/or site location.

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Recruiting
        • Innsbruck Medical University
        • Contact:
          • Corrine Horlings
        • Principal Investigator:
          • Werner Poewe, MD
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Recruiting
        • The Ottawa Hospital - Civic Campus
        • Principal Investigator:
          • Tiago Mestre
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Connie Marras
    • Quebec
      • Montreal, Quebec, Canada, H3A2B4
        • Recruiting
        • McGill University
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Ron Postuma
  • Germany
      • Hessen, Germany, 35043
        • Recruiting
        • Philipps-University of Marburg
        • Contact:
        • Principal Investigator:
          • Wolfgang Oertel
      • Kassel, Germany, 34128
        • Recruiting
        • Paracelsus-Elena Klinik
        • Contact:
        • Principal Investigator:
          • Brit Mollenhauer, MD
      • Lübeck, Germany, 23562
      • Tübingen, Germany, 72076
        • Recruiting
        • University of Tuebingen
        • Contact:
        • Sub-Investigator:
          • Isabel Wurster, MD
        • Principal Investigator:
          • Kathrin Brockmann
  • Greece
    • Athens
      • Athens, Athens, Greece, 11523
        • Recruiting
        • Foundation for Biomedical Research of the Academy of Athens
        • Contact:
        • Principal Investigator:
          • Leonidas Stefanis, MD, PhD
  • Israel
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Roy Alcalay, MD
  • Italy
    • Salerno
      • Salerno, Salerno, Italy, 84131
        • Recruiting
        • University of Salerno
        • Contact:
        • Principal Investigator:
          • Paolo Barone, MD
  • Luxembourg
      • Luxembourg, Luxembourg, L-1257
        • Recruiting
        • Parkinson Research Clinic
        • Principal Investigator:
          • Rejko Krueger
        • Contact:
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GC
  • Nigeria
    • Lagos
      • Lagos, Lagos, Nigeria, 121010
        • Recruiting
        • Lagos College of Medicine, University of Lagos
        • Contact:
        • Principal Investigator:
          • Njideka Okubadejo
  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Principal Investigator:
          • Eduardo Tolosa, MD
        • Principal Investigator:
          • Alicia Garrido, MD
        • Contact:
    • San Sebastian
      • Donostia / San Sebastian, San Sebastian, Spain, 20014
        • Recruiting
        • Hospital Donostia
        • Contact:
        • Principal Investigator:
          • Javier Ruiz Martinez, MD
  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Recruiting
        • Imperial College London
        • Principal Investigator:
          • Yen Tai, MD
        • Contact:
      • Oxford, United Kingdom, Oxford, OX3 9DU
        • Recruiting
        • John Radcliffe Hospital Oxford and Oxford University
        • Principal Investigator:
          • Michele Hu
        • Contact:
    • Britain
      • London, Britain, United Kingdom, EC1M 6BQ
        • Recruiting
        • Queen Mary University of London
        • Contact:
        • Principal Investigator:
          • Cristina Simonet
        • Principal Investigator:
          • Alastair Noyce
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE45PL
        • Recruiting
        • Newcastle University
        • Principal Investigator:
          • Nicola Pavese
        • Contact:
        • Sub-Investigator:
          • David Ledingham
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Sub-Investigator:
          • David Standaert, MD
        • Principal Investigator:
          • Marissa Dean, MD
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Holly Shill, MD
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Foundation for Medical Education and Research
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Shyamal Mehta, MD
        • Sub-Investigator:
          • Charles Adler, MD
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Banner Research Institute
        • Principal Investigator:
          • David Shprecher
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Sub-Investigator:
          • Sara Dhanani, MD
    • California
      • La Jolla, California, United States, 92093-0948
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • Douglas Galasko, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck School of Medicine of USC
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Mark Lew
      • San Francisco, California, United States, 94115
        • Recruiting
        • University of California, San Francisco
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Caroline Tanner, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Michelle Fullard, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Institute For Neurodegenerative Disorders
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Neha Prakash, MD
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Parkinson's Disease& Movement Disorder Center of Boca Raton
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Stuart Isaacson, MD
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Nikolaus McFarland
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Robert Hauser, MD
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory University School of Medicine
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Stewart A Factor, DO
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Tanya Simuni, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Rajesh Pahwa, MD
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Emile Moukheiber, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Marie H. Saint-Hilaire, MD
      • Boston, Massachusetts, United States, 02446
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Aleksandar Videnovic, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Kelvin Chou
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Cleveland Clinic Lou Ruvo Center for Brain Health
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Zoltan Mari, MD
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone Health
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Sub-Investigator:
          • Un Kang
        • Principal Investigator:
          • Giulietta Riboldi
      • New York, New York, United States, 10003
        • Recruiting
        • Beth Israel Medical Center
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Katherine Leaver, MD
      • Rochester, New York, United States, 14620
        • Recruiting
        • University of Rochester
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Ruth Schneider, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati/Cincinnati Children's Hospital
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Alberto Espay, MD, MSC
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Hubert H. Fernandez, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health &Science University
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Joseph Quinn, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Nabila Dahodwala, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Abby Olsen, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Arjun Tarakad, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Univ of Washington and VA Puget Sound Health Care System
        • Contact:
          • PPMI Call Center
          • Phone Number: 877-525-7764
        • Principal Investigator:
          • Cyrus Zabetian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally from approximately 50-55 international clinical sites across a variety of cohorts, including healthy controls, Parkinson disease, PD manifesting gene carriers, and Prodromal (those at risk for developing PD).

Description

7.1 Healthy Controls (HC) Note: Active Healthy controls previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.1.1 Inclusion Criteria (HC)

  1. Male or female age 57 years or older at Screening visit.
  2. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.
  3. Confirmation that participant is eligible based on Screening SPECT imaging.
  4. Able to provide informed consent.

  5. Either is male, or is female and meets additional criteria below, as applicable:

    • 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.

7.1.2 Exclusion Criteria (HC)

  1. First degree relative with PD (i.e., biologic parent, sibling, child).
  2. Current or active clinically significant neurological disorder (in the opinion of the Investigator).
  3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
  4. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
  5. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.
  6. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  7. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.2 Parkinson's Disease (PD) Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.2.1 Inclusion Criteria (PD)

  1. Male or female age 30 years or older at Screening Visit.
  2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.
  3. Not expected to require PD medication within at least 6 months from Baseline.
  4. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
  5. Hoehn and Yahr stage I or II at Baseline.
  6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.
  7. Confirmation that participant is eligible based on Screening SPECT imaging.
  8. Able to provide informed consent.

  9. Either is male, or is female and meets additional criteria below, as applicable:

    • 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.

7.2.2 Exclusion Criteria (PD)

  1. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).
  2. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit.
  3. Has taken levodopa or dopamine agonists prior to Baseline visit for more than a total of 90 days.
  4. Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
  5. A clinical diagnosis of dementia as determined by the investigator.
  6. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
  7. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
  8. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.
  9. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  10. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  11. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.3 Parkinson's Disease (PD) with LRRK2 or GBA variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.3.1 Inclusion Criteria (PD ¬- LRRK2 or GBA)

  1. Male or female age 30 years or older at Screening Visit.
  2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.
  3. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
  4. Hoehn and Yahr stage I or II at Baseline.
  5. Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).
  6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.
  7. Confirmation that participant is eligible based on Screening SPECT imaging.
  8. Able to provide informed consent.

  9. Either is male, or is female and meets additional criteria below, as applicable:

    • 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.

7.3.2 Exclusion Criteria (PD - LRRK2 or GBA)

  1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
  2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.4 Parkinson's Disease (PD) with SNCA or rare genetic variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.4.1 Inclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))

  1. Male or female age 30 years or older at Screening Visit.
  2. Parkinson's disease diagnosis at Screening Visit.
  3. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
  4. Hoehn and Yahr stage I, II, or III at Baseline.
  5. Confirmation of causative SNCA or rare genetic variant (such as Parkin or Pink1) (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).
  6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.
  7. Confirmation that participant is eligible based on Screening SPECT imaging.
  8. Able to provide informed consent.

  9. Either is male, or is female and meets additional criteria below, as applicable:

    • 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.

7.4.2 Exclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))

  1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
  2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.5 Prodromal Note: Active Prodromal participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

The specific predictive eligibility criteria for participants recruited through PPMI Remote to advance to PPMI Clinical will be iteratively optimized based on data collected from these studies.

7.5.1 Inclusion criteria (Prodromal)

For Screening:

  1. Confirmation that participant is eligible based on centrally determined predictive criteria including the University of Pennsylvania Smell Identification Test (UPSIT).

    • 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.

    Additionally, confirmation of UPSIT eligibility during the Screening visit prior to SPECT Imaging.

  2. Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic variants (such as Parkin or Pink1) participants).
  3. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.
  4. Able to provide informed consent.

  5. Either is male, or is female and meets additional criteria below, as applicable:

    • 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 continuation to Baseline visit and ongoing follow-up:

  6. Confirmation that participant is eligible based on *Screening SPECT imaging.

    • Screening SPECT Imaging eligibility:

Based on the results of the SPECT imaging test, Prodromal participants eligible to continue their participation in PPMI Clinical will be asked to return for their PPMI Clinical baseline visit. Neither the participant nor the site investigator will be made aware of the participant's DAT status during the study.

  • 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.

7.5.2 Exclusion Criteria (Prodromal)

  1. Clinical diagnosis of PD at screening, other parkinsonism, or dementia.
  2. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Baseline Visit.
  3. Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  4. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  5. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  6. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).
  7. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit. except for low-dose treatment of restless leg syndrome (with permission of medical monitor).
  8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Clinical Observation
In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally once identified, over the course of 5-8 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive and uniformly acquired dataset
Time Frame: Baseline 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)
Baseline to 156 months
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.
Time Frame: Baseline to 156 months
This protocol will build on the existing PPMI infrastructure
Baseline to 156 months
Comparison between Rates of Change
Time Frame: Study 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.
Study intervals ranging from 3 months to 156 months
Prevalence of measures of clinical, imaging and biomic outcomes in various subsets
Time Frame: study 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.
study intervals ranging from baseline to 156 months.
Establish the probability of phenoconversion to PD
Time Frame: study 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).
study intervals ranging from baseline to 156 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael J. Fox Foundation for Parkinson's Research

Collaborators

Institute for Neurodegenerative Disorders

Investigators

  • Principal Investigator: Kenneth L Marek, MD, Institute For Neurodegenerative Disorders
  • Principal Investigator: Caroline Tanner, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPMI-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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