Genetic Testing for Parkinson's Disease

(PDGENE Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen by Roy N Alcalay, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Parkinson's Foundation

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Roy N Alcalay, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for people with a probable diagnosis of Parkinson's Disease who can consent to the study, complete surveys, and are willing to undergo genetic testing. They must understand the language of the informed consent. Those with blood cancers, recent bone marrow transplants or blood transfusions, or atypical parkinsonian disorders cannot participate.

Inclusion Criteria

I can complete study tasks, whether online, in-person, or on paper.

I understand the study details and have signed the consent forms.

Individuals must speak and understand the language of the informed consent

Exclusion Criteria

I have been diagnosed with a rare form of Parkinson's disease.

I have received a blood transfusion in the last 3 months.

I have an active blood cancer like lymphoma or leukemia.

Treatment Details

Interventions

• CLIA certified genetic testing (Genetic Testing)

Trial Overview The trial is offering certified genetic testing for seven specific gene variants linked to Parkinson's Disease as part of clinical care. It aims to evaluate how feasible and satisfying this process is for participants.

Participant Groups

Group I: Site-Based Genetic Counseling Active Control 1 Intervention

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

Group II: Centralized Genetic Counseling Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Parkinson's Foundation

Lead Sponsor

Trials

13

Recruited

1,030,000+

University of Rochester - CHeT/CTCC

Collaborator

Trials

1

Recruited

2,000+

Fulgent Laboratories

Collaborator

Trials

1

Recruited

2,000+

The Parkinson Study Group

Collaborator

Trials

17

Recruited

32,500+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Navitas Clinical Research, Inc

Collaborator

Trials

4

Recruited

2,300+