Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Parkinson Progression Marker Initiative Online (PPMI Online)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05065060
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Caroline M Tanner, University of California, San Francisco

Brief Summary:

Parkinson Progression Marker Initiative Online (PPMI Online) is an observational study collecting participant reported information from people with and without Parkinson's disease (PD), for the goal of better understanding risk and predictive factors for PD.

PPMI Online is part of the broader Parkinson Progression Marker Initiative aimed at identifying markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.


Condition or disease Intervention/treatment
Parkinson Disease Other: Observation

Detailed Description:
PPMI is a broad program that is expanding the goals of the original PPMI study, and will include this PPMI Online protocol, as well the PPMI Clinical [NCT04477785], PPMI Remote, PPMI Digital protocols (with external regulatory oversight). All participants in PPMI may be asked to participate in one or all of these protocols and their enrollment in these studies may occur in varying order. PPMI participants may also be asked to participate in additional PPMI companion studies (as they are developed), which may only involve a subset of PPMI participants based on their cohort designation

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Parkinson's Progression Markers Initiative Online Study (PPMI Online)
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : December 2041
Estimated Study Completion Date : December 2041

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Observation
    Observation


Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale Ib & II [ Time Frame: Baseline to 240 months ]
    Evaluates self-reported motor and nonmotor Parkinson's disease symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In PPMI Online, up to 500,000 participants with and without PD will be enrolled and contribute data longitudinally and cross-sectionally using a web-based platform.
Criteria

Inclusion Criteria:

  • Parkinson Disease (PD) Participants:

    • Male or female age 18 years or older.
    • Has received a diagnosis of Parkinson's disease

Participants without PD:

  • Male or female age 18 years or older.
  • Has not received a diagnosis of Parkinson's disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065060


Contacts
Layout table for location contacts
Contact: University of California, San Francisco 877-525-7764 info@ppmionline.org

Locations
Layout table for location information
United States, California
UCSF Movement Disorders and Neuromodulation Center (MDNC) Recruiting
San Francisco, California, United States, 94143
Contact: UCSF    877-525-7764      
Sponsors and Collaborators
Michael J. Fox Foundation for Parkinson's Research
Investigators
Layout table for investigator information
Principal Investigator: Caroline Tanner, MD, PhD University of California, San Francisco
Principal Investigator: Kenneth L Marek, MD Institute for Neurodegenerative Disorders
Layout table for additonal information
Responsible Party: Caroline M Tanner, Protocol Co- Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05065060    
Other Study ID Numbers: PPMI-007
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caroline M Tanner, University of California, San Francisco:
Parkinson
Neurodegenerative Disorder
Prodromal
At Risk
Participant Reported Outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases