Status:
UNKNOWN
PDGeneration: Mapping the Future of Parkinson's Disease
Lead Sponsor:
Parkinson's Foundation
Collaborating Sponsors:
Fulgent Laboratories
Indiana University
Conditions:
Parkinson's Disease and Parkinsonism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Parkins...
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 ...
Eligibility Criteria
Inclusion
- Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
- 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).
- Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
- Able to perform study activities (including completion of either online, in-person or paper surveys).
- Individuals must speak and understand the language of the informed consent.
Exclusion
- 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.
- Individuals who have active hematologic malignancies such as lymphoma or leukemia.
- Individuals who have had a bone marrow transplant within the past 5 years.
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
1982 Patients enrolled
Trial Details
Trial ID
NCT04057794
Start Date
August 15 2019
End Date
April 15 2025
Last Update
July 14 2023
Active Locations (13)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
University of California San Diego (UCSD)
La Jolla, California, United States, 92093
3
University of Miami
Fort Lauderdale, Florida, United States, 33308
4
Cleveland Clinic Florida-Weston
Weston, Florida, United States, 33331