PDGeneration: Mapping the Future of Parkinson’s Disease

Overview

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).

Full Title of Study: “Parkinson’s Foundation: PD Generation: Mapping the Future of Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 15, 2020

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 study will be a longitudinal, multi-center study to evaluate how providing CLIA-certified genetic testing and genetic counseling by the Parkinson's Foundation for PD-related genes impacts people with Parkinson's lives, their clinical care, and knowledge of the PD genetics. The will also assess the impact of the mode of genetic counseling by comparing counseling conducted by a clinician in-person versus genetic counseling conducted through telephone. Knowledge of genetic status may have significant implications on clinical care, potential treatment options, and may provide insight on the rate of disease and PD prognosis.

Interventions

  • Device: Lab Assay for seven genetic variants for Parkinson’s Disease
    • Counseling provided to participant by an in-person visit by site clinician/physician
  • Device: Lab Assay for seven genetic variants for Parkinson’s Disease
    • Counseling provided to participant by telephone from Genetic Specialists from Indiana University

Arms, Groups and Cohorts

  • Experimental: On-Site Genetic Counseling
    • Participants randomized to this part of the study will receive Counseling for genetic results.
  • Active Comparator: Telephone Genetic Counseling
    • Participants randomized to this part of the study will receive Counseling for genetic results.

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility Outcome
    • Time Frame: up to 24 weeks
    • To provide satisfactory counseling via two different modes of counseling, either by phone from genetic counselors or at an on-site meeting with a clinician/physician, to participants with Parkinson’s thereby assessing participants level of satisfaction of said counseling by returned survey response.
  • Evaluation
    • Time Frame: up to 48 weeks
    • 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.
  • Comparison
    • Time Frame: up to 48 weeks
    • Differences in satisfaction of receiving counseling by provider (genetic counselor vs. site clinician/physician) by returned survey responses of providers of Parkinson’s care and participants with Parkinson’s.

Secondary Measures

  • Ready to enroll in precision medicine trials
    • Time Frame: up to 12 months
    • number of participants
  • Time
    • Time Frame: up to 12 months
    • comparison of first contact to return of results

Participating in This Clinical Trial

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 English language.

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Parkinson’s Foundation
  • Collaborator
    • University of Rochester – CHeT/CTCC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Roy N Alcalay, MD, MS, Principal Investigator, Columbia University
  • Overall Contact(s)
    • Elizabeth U Lyda, BS, 585-273-4038, elizabeth.lyda@chet.rochester.edu

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