Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Parkinson's Disease and Parkinsonism Parkinson's Genetics PD Genetics Parkinson Disease Parkinsonian Disorders Lab Assay for seven genetic variants for Parkinson's Disease On-Site Genetic Counseling Telephone Genetic Counseling

Eligibility

You can join if…

Open to people ages 18 years and up

    1. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's

Disease: probable diagnosis.

  1. 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).
  2. Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
  3. Able to perform study activities (including completion of either online, in-person or paper surveys).
  4. Individuals must speak and understand the English language.

You CAN'T join if...

    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.
  • Individuals who have received a blood transfusion within the past 3 months. 3. Individuals who have active hematologic malignancies such as lymphoma or leukemia.
  • Individuals who have had a bone marrow transplant within the past 5 years.

Locations

  • University of California San Diego (UCSD) not yet accepting patients
    La Jolla California 92093 United States
  • Health Partners/Park Nicollet: Struthers Parkinson's Center accepting new patients
    Minneapolis Minnesota 55427 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Parkinson's Foundation
ID
NCT04057794
Study Type
Interventional
Last Updated