Parkinson's Foundation PD GENEration Genetic Registry

NCT04994015 | Recruiting

• 1 other identifier: PDGENE-PF
• Study Type: observational
• Target: 25,000
• Locations: 3 countries
• Sites: 56

Brief Summary

Development of a central repository for PD-related genomic data for future research.

Conditions

Parkinson's Disease

Keywords

Genetics; Genetic Counseling; Whole Genome Sequencing

Outcome Measures

Primary Outcomes (2)

• Prevalence of Parkinson's related genetic mutations in an convenience cohort

  Identify people with Parkinson's who have genetic mutations to advance basic science and clinical research.

  6 months

• Educating people with Parkinson's of their genetic mutation status through genetic testing and counseling

  People who are informed of their genetic status may be empowered to learn more about their disease and participant in clinical research.

  6 months

Interventions

Lab Assay for seven genetic variants for Parkinson's Disease DEVICE

Counseling provided to participant by site clinician/physician/genetic counselor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any person with probable diagnosis of Parkinson's disease according to the Movement Disorders Society criteria.

You may qualify if:

• Study Population 1: PWP (open for recruitment)
• Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
• Willingness to undergo genetic testing, and choose to be informed of genetic testing results for GBA, LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
• Capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (ICFs) based on site clinician's determination.
• Able to perform study activities (including completion of either online, in-person or paper surveys).
• Study Population 2: People at risk of developing PD (not open for recruitment)
• \. Family members of Study Population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory.

You may not qualify if:

• Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
• Individuals who have received a blood transfusion within the past 3 months.
• Individuals who have active hematologic malignancies such as lymphoma or leukemia.
• Individuals who have had a bone marrow transplant within the past 5 years.
• Under the age of 18

Sponsors & Collaborators

• Parkinson's Foundation: lead
• Indiana University: collaborator
• Fulgent Genetics: collaborator
• The Parkinson Study Group: collaborator

Study Sites (56)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MD First Research

Chandler, Arizona, 85286, United States

TERMINATED

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

University of Arkansas

Fayetteville, Arkansas, 72701, United States

RECRUITING

University of California San Diego (UCSD)

La Jolla, California, 92093, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

RECRUITING

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

Hartford Healthcare

Hartford, Connecticut, 06066, United States

RECRUITING

Aventura Neurology - Visionary Investigators Network

Aventura, Florida, 33180, United States

RECRUITING

Parkinson's Disease & Movement Disorder Center of Boca Raton

Boca Raton, Florida, 33486, United States

RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

University of Miami

Miami, Florida, 33131, United States

RECRUITING

Cleveland Clinic Weston

Weston, Florida, 33331, United States

RECRUITING

Morehouse College

Atlanta, Georgia, 30314, United States

RECRUITING

The Queen's Health System

Honolulu, Hawaii, 96813, United States

RECRUITING

University of Illinois-Chicago

Chicago, Illinois, 60607, United States

RECRUITING

Rush University

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas

Lawrence, Kansas, 66045, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Louisiana State University

Shreveport, Louisiana, 71103, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21218, United States

RECRUITING

University of Maryland

College Park, Maryland, 20742, United States

RECRUITING

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

RECRUITING

BMC Community Hospital

Boston, Massachusetts, 02136, United States

RECRUITING

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

RECRUITING

Struthers Parkinson's Center - HealthPartners Park Nicollet

Golden Valley, Minnesota, 55427, United States

RECRUITING

Rutgers University

New Brunswick, New Jersey, 08854, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87106, United States

RECRUITING

New York University

New York, New York, 10017, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University

New York, New York, 10033, United States

RECRUITING

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Atrium Health

Charlotte, North Carolina, 28207, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45221, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19144, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37235, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas at San Antonio

San Antonio, Texas, 78249, United States

RECRUITING

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

RECRUITING

Evergreen Health

Kirkland, Washington, 98034, United States

RECRUITING

Inland Northwest Research

Spokane, Washington, 99202, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Isolated DNA from buccal swab or whole blood.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• James Beck, PhD

  Parkinson's Foundation

  PRINCIPAL INVESTIGATOR

• Roy N Alcalay, MS, MD

  Tel Aviv Sourasky Medical Center, Columbia University Irving Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamalini Ghosh, MS

CONTACT

1-800-473-4636; kghosh@parkinson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: December 20, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

US (54); IL (1); CA (1)