PDGeneration: Mapping the Future of Parkinson's Disease

NCT ID: NCT04057794

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1982 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2025-04-15

Brief Summary

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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

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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

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Parkinson's Disease and Parkinsonism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Site-Based Genetic Counseling

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

Group Type ACTIVE_COMPARATOR

Lab Assay for seven genetic variants for Parkinson's Disease

Intervention Type DEVICE

Counseling provided to participant by site clinician/physician/genetic counselor.

Centralized Genetic Counseling

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

Group Type ACTIVE_COMPARATOR

Lab Assay for seven genetic variants for Parkinson's Disease

Intervention Type DEVICE

Counseling provided to participant by centralized genetic counseling group at Indiana University.

Interventions

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Lab Assay for seven genetic variants for Parkinson's Disease

Counseling provided to participant by site clinician/physician/genetic counselor.

Intervention Type DEVICE

Lab Assay for seven genetic variants for Parkinson's Disease

Counseling provided to participant by centralized genetic counseling group at Indiana University.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fulgent Laboratories

UNKNOWN

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

The Parkinson Study Group

NETWORK

Sponsor Role collaborator

Navitas Clinical Research, Inc

UNKNOWN

Sponsor Role collaborator

Parkinson's Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roy N Alcalay, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

University of California San Diego (UCSD)

La Jolla, California, United States

Site Status

University of Miami

Fort Lauderdale, Florida, United States

Site Status

Cleveland Clinic Florida-Weston

Weston, Florida, United States

Site Status

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Health Partners/Park Nicollet: Struthers Parkinson's Center

Minneapolis, Minnesota, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.parkinson.org/PDGENEration

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

Other Identifiers

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PDGene-01

Identifier Type: -

Identifier Source: org_study_id

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