Parkinson's Foundation PD GENEration Genetic Registry

Parkinson's Foundation

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Device: Lab Assay for seven genetic variants for Parkinson's Disease

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT04994015

PDGENE-PF

Details and patient eligibility

About

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

Full 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.

Enrollment: 25,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design