NCT04057794

PDGeneration: Mapping the Future of Parkinson's Disease

Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,982 (actual)
• Sponsor: Parkinson's Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Parkinson's Disease and Parkinsonism

Interventions

Type	Name	Description
DEVICE	Lab Assay for seven genetic variants for Parkinson's Disease	Counseling provided to participant by site clinician/physician/genetic counselor.
DEVICE	Lab Assay for seven genetic variants for Parkinson's Disease	Counseling provided to participant by centralized genetic counseling group at Indiana University.

Timeline

• Start date: 2019-08-15
• Primary completion: 2021-12-01
• Completion: 2025-04-15
• First posted: 2019-08-15
• Last updated: 2023-07-14

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study