Genetic Testing for Parkinson's Disease

(PDGENE Trial)

Recruiting at 12 trial locations

Overseen By Jill Goldman, CGC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Parkinson's Foundation

Disqualifiers: Atypical parkinsonian disorder, Blood transfusion, Hematologic malignancies, Bone marrow transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1982 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing and Counseling

Participants receive CLIA certified genetic testing and genetic counseling either through the enrolling site or a centralized group at Indiana University

up to 24 weeks

1 visit for genetic counseling

Follow-up

Participants are monitored for satisfaction, feasibility, and impact of genetic testing and counseling

up to 6 months

Long-term Follow-up

Participants' enrollment in precision medicine trials is tracked

up to 12 months

Treatment Details

Interventions

• CLIA certified 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+

Navitas Clinical Research, Inc

Collaborator

Trials

4

Recruited

2,300+