Parkinson's Disease Clinical Trial
Official title:
Parkinson's Foundation PD GENEration Genetic Registry
NCT number | NCT04994015 |
Other study ID # | PDGENE-PF |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 20, 2020 |
Est. completion date | June 1, 2025 |
Development of a central repository for PD-related genomic data for future research.
Status | Recruiting |
Enrollment | 25000 |
Est. completion date | June 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Study Population 1: PWP (open for recruitment) 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 GBA, LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7). 3. Capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (ICFs) based on site clinician's determination. 4. Able to perform study activities (including completion of either online, in-person or paper surveys). Study Population 2: People at risk of developing PD (not open for recruitment) 1. Family members of Study Population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory. 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. 5. Under the age of 18 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Western Hospital | Toronto | Ontario |
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
United States | Morehouse College | Atlanta | Georgia |
United States | Aventura Neurology - Visionary Investigators Network | Aventura | Florida |
United States | Johns Hopkins | Baltimore | Maryland |
United States | Parkinson's Disease & Movement Disorder Center of Boca Raton | Boca Raton | Florida |
United States | Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts |
United States | Massachusetts General Hospital (MGH) | Boston | Massachusetts |
United States | St. Elizabeth's Medical Center | Boston | Massachusetts |
United States | MD First Research | Chandler | Arizona |
United States | University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Atrium Health | Charlotte | North Carolina |
United States | Rush University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | University of Illinois-Chicago | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University of Maryland | College Park | Maryland |
United States | Ohio State University | Columbus | Ohio |
United States | Northwestern University | Evanston | Illinois |
United States | University of Arkansas | Fayetteville | Arkansas |
United States | University of Florida | Gainesville | Florida |
United States | Struthers Parkinson's Center - HealthPartners Park Nicollet | Golden Valley | Minnesota |
United States | The Queen's Health System | Honolulu | Hawaii |
United States | Baylor College of Medicine | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Iowa | Iowa City | Iowa |
United States | University of California San Diego (UCSD) | La Jolla | California |
United States | University of Kansas | Lawrence | Kansas |
United States | University of Kentucky | Lexington | Kentucky |
United States | University of Miami | Miami | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Rutgers University | New Brunswick | New Jersey |
United States | Columbia University | New York | New York |
United States | Mount Sinai | New York | New York |
United States | New York University | New York | New York |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Barrow Neurological Institute | Phoenix | Arizona |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | University of Texas at San Antonio | San Antonio | Texas |
United States | University of California San Francisco (UCSF) | San Francisco | California |
United States | Inland Northwest Research | Spokane | Washington |
United States | Cleveland Clinic Weston | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
Parkinson's Foundation | Fulgent Genetics, Indiana University, The Parkinson Study Group |
United States, Canada, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of Parkinson's related genetic mutations in an convenience cohort | Identify people with Parkinson's who have genetic mutations to advance basic science and clinical research. | 6 months | |
Primary | Educating people with Parkinson's of their genetic mutation status through genetic testing and counseling | People who are informed of their genetic status may be empowered to learn more about their disease and participant in clinical research. | 6 months |
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