PDGeneration: Mapping the Future of Parkinson's Disease

Parkinson's Disease and Parkinsonism Clinical Trial

— PDGENE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04057794
• Other study ID #: PDGene-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: April 15, 2025

Study information

• Verified date: July 2023
• Source: Parkinson's Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1982
• Est. completion date: April 15, 2025
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders

Intervention

Device:
• Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by site clinician/physician/genetic counselor.
• Lab Assay for seven genetic variants for Parkinson's Disease
Counseling provided to participant by centralized genetic counseling group at Indiana University.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Miami	Fort Lauderdale	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California San Diego (UCSD)	La Jolla	California
United States	Health Partners/Park Nicollet: Struthers Parkinson's Center	Minneapolis	Minnesota
United States	Beth Israel Medical Center	New York	New York
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Cleveland Clinic Florida-Weston	Weston	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Parkinson's Foundation	Fulgent Laboratories, Indiana University, Navitas Clinical Research, Inc, The Parkinson Study Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of genetic testing and counseling	The total number of participants who receive genetic testing and counseling.	up to 24 weeks
Primary	Impact Evaluation	The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling.	up to 6 months
Primary	Satisfaction Comparison	Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score.	up to 6 months
Secondary	Number of participants that enroll in precision medicine trials	Number of participants that enroll in precision medicine trials	up to 12 months
Secondary	Time it takes between first contact to the return of genetic test results	Number of weeks it takes between participant consent to return of genetic test results.	up to 12 months

External Links

•   For more information and to enroll, please visit the website.