PDGeneration: Mapping the Future of Parkinson's Disease (PDGENE)

July 12, 2023 updated by: Parkinson's Foundation

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1982

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego (UCSD)
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • University of Miami
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida-Weston
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55427
        • Health Partners/Park Nicollet: Struthers Parkinson's Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Site-Based Genetic Counseling
Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.
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.
Active Comparator: Centralized Genetic Counseling
Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact Evaluation
Time Frame: up to 6 months
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
Satisfaction Comparison
Time Frame: up to 6 months
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
Feasibility of genetic testing and counseling
Time Frame: up to 24 weeks
The total number of participants who receive genetic testing and counseling.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that enroll in precision medicine trials
Time Frame: up to 12 months
Number of participants that enroll in precision medicine trials
up to 12 months
Time it takes between first contact to the return of genetic test results
Time Frame: up to 12 months
Number of weeks it takes between participant consent to return of genetic test results.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parkinson's Foundation

Collaborators

Indiana University
The Parkinson Study Group
Navitas Clinical Research, Inc
Fulgent Laboratories

Investigators

  • Principal Investigator: Roy N Alcalay, MD, MS, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2019

Primary Completion (Actual)

December 1, 2021

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDGene-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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