PDGeneration: Mapping the Future of Parkinson's Disease

Status unconfirmed · Not applicable

Conditions studied: Parkinson's Disease and Parkinsonism

In brief

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).

Key facts

Study ID

NCT04057794

Run by

Parkinson's Foundation

People needed

1982

Starts

2019-08-15

Expected to finish

2025-04-15

Last updated by the study team

2023-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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