Parkinson's Foundation PD GENEration Genetic Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lab Assay for seven genetic variants for Parkinson's Disease.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by site clinician/physician/genetic counselor.
Primary outcome measures
- Prevalence of Parkinson's related genetic mutations in an convenience cohort [Time frame: 6 months]
- Educating people with Parkinson's of their genetic mutation status through genetic testing and counseling [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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)
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 54 centers
- University of Alabama Birmingham — Birmingham
- MD First Research — Chandler
- Barrow Neurological Institute — Phoenix
- University of Arkansas — Fayetteville
- University of California San Diego (UCSD) — La Jolla
- University of California Los Angeles — Los Angeles
- University of California San Francisco (UCSF) — San Francisco
- University of Colorado Anschutz — Aurora
- … and 46 more centers
Canada · 1 center
- Toronto Western Hospital — Toronto
Israel · 1 center
- Tel Aviv Sourasky Medical Center — Tel Aviv
Identifiers
NCT: NCT04994015 · PDGENE-PF