Actively Recruiting

Age: 30Years +
All Genders
Healthy Volunteers
NCT04477785

PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort

Led by Michael J. Fox Foundation for Parkinson's Research · Updated on 2026-03-27

4500

Participants Needed

50

Research Sites

700 weeks

Total Duration

On this page

Sponsors

M

Michael J. Fox Foundation for Parkinson's Research

Lead Sponsor

I

Institute for Neurodegenerative Disorders

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort

Who Can Participate

Age: 30Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be male or female aged 30 years or older at screening.
  • Diagnosis of Parkinson's disease for 2 years or less at screening (for PD groups).
  • Must not require Parkinson's medication for at least 6 months from baseline.
  • Must have at least two Parkinson's symptoms: resting tremor, bradykinesia, rigidity (must include resting tremor or bradykinesia), or asymmetric resting tremor or bradykinesia.
  • Hoehn and Yahr stage I or II at baseline (I, II, or III for rare genetic variants).
  • Willingness and ability to hold certain medications like alpha methyldopa, methylphenidate, amphetamine derivatives, or modafinil for at least 5 half-lives before SPECT imaging.
  • Eligibility confirmed by screening SPECT imaging.
  • Able to provide informed consent.
  • Females of childbearing potential must not be pregnant, lactating, or planning pregnancy during the study and must have a negative pregnancy test before SPECT imaging.
  • Healthy controls must be 57 years or older.
  • Prodromal participants must be 60 years or older (30 or older for some genetic variants) with eligibility confirmed by smell test and screening SPECT imaging.
  • Genetic PD groups must have confirmation of specific genetic variants and be willing to undergo genetic testing or provide prior results.
Not Eligible

You will not qualify if you...

  • First degree relative with Parkinson's disease (for healthy controls).
  • Current or active significant neurological disorder or MRI evidence of such.
  • Use of dopamine receptor blockers, metoclopramide, or reserpine within 6 months before screening.
  • Current treatment with anticoagulants that prevent safe lumbar puncture.
  • Conditions preventing safe lumbar puncture like spinal disease, bleeding disorders, or coagulopathy.
  • Any medical or psychiatric condition or lab abnormality that may prevent participation.
  • For PD participants, current or recent use of Parkinson's medications, except low-dose treatment for restless leg syndrome with approval.
  • Clinical diagnosis of dementia.
  • Clinical diagnosis of Parkinson's, other parkinsonism, or dementia at screening (for prodromal group).
  • Any other reason deemed by the investigator to make the participant unsuitable for the study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 50 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Barrow Neurological Institute

Phoenix, Arizona, United States, 85013

Actively Recruiting

3

Mayo Foundation for Medical Education and Research

Scottsdale, Arizona, United States, 85259

Actively Recruiting

4

Banner Research Institute

Sun City, Arizona, United States, 85351

Actively Recruiting

5

University of California San Diego

La Jolla, California, United States, 92093-0948

Actively Recruiting

6

Keck School of Medicine of USC

Los Angeles, California, United States, 90033

Actively Recruiting

7

University of California, San Francisco

San Francisco, California, United States, 94115

Actively Recruiting

8

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

9

Institute For Neurodegenerative Disorders

New Haven, Connecticut, United States, 06510

Actively Recruiting

10

Parkinson's Disease& Movement Disorder Center of Boca Raton

Boca Raton, Florida, United States, 33486

Actively Recruiting

11

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

12

University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

13

Emory University School of Medicine

Atlanta, Georgia, United States, 30329

Actively Recruiting

14

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

15

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

16

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

17

Boston University

Boston, Massachusetts, United States, 02118

Actively Recruiting

18

Massachusetts General Hospital

Boston, Massachusetts, United States, 02446

Actively Recruiting

19

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

20

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States, 89106

Actively Recruiting

21

Beth Israel Medical Center

New York, New York, United States, 10003

Actively Recruiting

22

NYU Langone Health

New York, New York, United States, 10017

Actively Recruiting

23

University of Rochester

Rochester, New York, United States, 14620

Actively Recruiting

24

University of Cincinnati/Cincinnati Children's Hospital

Cincinnati, Ohio, United States, 45219

Actively Recruiting

25

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

26

Oregon Health &Science University

Portland, Oregon, United States, 97239

Actively Recruiting

27

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

28

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

29

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

30

Univ of Washington and VA Puget Sound Health Care System

Seattle, Washington, United States, 98104

Actively Recruiting

31

Innsbruck Medical University

Innsbruck, Austria, 6020

Actively Recruiting

32

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada, K1Y 4E9

Actively Recruiting

33

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

34

McGill University

Montreal, Quebec, Canada, H3A2B4

Actively Recruiting

35

Philipps-University of Marburg

Hessen, Germany, 35043

Actively Recruiting

36

Paracelsus-Elena Klinik

Kassel, Germany, 34128

Actively Recruiting

37

University of Luebeck

Lübeck, Germany, 23562

Actively Recruiting

38

University of Tuebingen

Tübingen, Germany, 72076

Actively Recruiting

39

Foundation for Biomedical Research of the Academy of Athens

Athens, Athens, Greece, 11523

Actively Recruiting

40

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, Israel, 64239

Actively Recruiting

41

University of Salerno

Salerno, Salerno, Italy, 84131

Actively Recruiting

42

Parkinson Research Clinic

Luxembourg, Luxembourg, L-1257

Actively Recruiting

43

Radboud University

Nijmegen, Gelderland, Netherlands, 6525 GC

Actively Recruiting

44

Lagos College of Medicine, University of Lagos

Lagos, Lagos, Nigeria, 121010

Actively Recruiting

45

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain, 08036

Actively Recruiting

46

Hospital Donostia

Donostia / San Sebastian, San Sebastian, Spain, 20014

Actively Recruiting

47

Queen Mary University of London

London, Britain, United Kingdom, EC1M 6BQ

Actively Recruiting

48

Newcastle University

Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE45PL

Actively Recruiting

49

Imperial College London

London, United Kingdom, W12 0NN

Actively Recruiting

50

John Radcliffe Hospital Oxford and Oxford University

Oxford, United Kingdom, Oxford, OX3 9DU

Actively Recruiting

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Research Team

C

Cari Rainville, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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