PDGeneration: Mapping the Future of Parkinson's Disease (PDGENE)

Parkinson's Foundation

Status: Active, not recruiting

Conditions: Parkinson's Disease and Parkinsonism

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

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04057794

PDGene-01

Details and patient eligibility

About

To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).

Full description

The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through Indiana University. The study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. All genetic test results will be returned to participants through a genetic counseling visit.

Enrollment: 1,982 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
3. Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
4. Able to perform study activities (including completion of either online, in-person or paper surveys).
5. Individuals must speak and understand the language of the informed consent.

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,982 participants in 2 patient groups

Site-Based Genetic Counseling

Active Comparator group

Description:

Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.

Treatment:

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

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

Centralized Genetic Counseling

Active Comparator group

Description:

Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.

Treatment:

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

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