Parkinson's Foundation PD GENEration Genetic Registry

Parkinson's Disease Clinical Trial

Official title:

Parkinson's Foundation PD GENEration Genetic Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994015
• Other study ID #: PDGENE-PF
• Status: Recruiting
• Start date: December 20, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Parkinson's Foundation
• Contact: Kamalini Ghosh, MS
• Phone: 1-800-473-4636
• Email: kghosh[@]parkinson.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

The purpose of this study is to develop a central repository for PD-related genomic data by individuals who consent to deposit their data and bank their residual DNA obtained through clinical genetic testing for future research use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study Population 1: PWP (open for recruitment)

1. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.

2. 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).

3. 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.

4. 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)

1. 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.

Exclusion Criteria:

1. 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.

2. Individuals who have received a blood transfusion within the past 3 months.

3. Individuals who have active hematologic malignancies such as lymphoma or leukemia.

4. Individuals who have had a bone marrow transplant within the past 5 years.

5. Under the age of 18

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by site clinician/physician/genetic counselor.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
United States	Morehouse College	Atlanta	Georgia
United States	Aventura Neurology - Visionary Investigators Network	Aventura	Florida
United States	Johns Hopkins	Baltimore	Maryland
United States	Parkinson's Disease & Movement Disorder Center of Boca Raton	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Massachusetts General Hospital (MGH)	Boston	Massachusetts
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	MD First Research	Chandler	Arizona
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Atrium Health	Charlotte	North Carolina
United States	Rush University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois-Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Maryland	College Park	Maryland
United States	Ohio State University	Columbus	Ohio
United States	Northwestern University	Evanston	Illinois
United States	University of Arkansas	Fayetteville	Arkansas
United States	University of Florida	Gainesville	Florida
United States	Struthers Parkinson's Center - HealthPartners Park Nicollet	Golden Valley	Minnesota
United States	The Queen's Health System	Honolulu	Hawaii
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of California San Diego (UCSD)	La Jolla	California
United States	University of Kansas	Lawrence	Kansas
United States	University of Kentucky	Lexington	Kentucky
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Rutgers University	New Brunswick	New Jersey
United States	Columbia University	New York	New York
United States	Mount Sinai	New York	New York
United States	New York University	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Texas at San Antonio	San Antonio	Texas
United States	University of California San Francisco (UCSF)	San Francisco	California
United States	Inland Northwest Research	Spokane	Washington
United States	Cleveland Clinic Weston	Weston	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Parkinson's Foundation	Fulgent Genetics, Indiana University, The Parkinson Study Group

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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