Parkinson's Foundation PD GENEration Genetic Registry

Recruiting

• Conditions: Parkinson's Disease

• Registration Number: NCT04994015
• Lead Sponsor: Parkinson's Foundation

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-12-20
• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Educating people with Parkinson's of their genetic mutation status through genetic testing and counseling	6 months	People who are informed of their genetic status may be empowered to learn more about their disease and participant in clinical research.
Prevalence of Parkinson's related genetic mutations in an convenience cohort	6 months	Identify people with Parkinson's who have genetic mutations to advance basic science and clinical research.

Trial Locations

Locations (56)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

MD First Research; 🇺🇸 Chandler, Arizona, United States

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

University of California San Diego (UCSD); 🇺🇸 La Jolla, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

University of Colorado Anschutz; 🇺🇸 Aurora, Colorado, United States

Hartford Healthcare; 🇺🇸 Hartford, Connecticut, United States

Aventura Neurology - Visionary Investigators Network; 🇺🇸 Aventura, Florida, United States

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