Trial-Ready Cohort-Down Syndrome (TRC-DS)
Condition(s) studied
Study summary
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 550 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression.
To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/.
TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.
Eligibility
Primary outcome measure(s)
- Enrollment of participants into the Trial-Ready Cohort in DS (TRC-DS). — 5 years
The primary aim of the TRC-DS is enrollment of 120 participants into the trial ready cohort, with up to 550 participants in total including co-enrollment with the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study, to support future referral and enrollment into primary Alzheimer's disease (AD) prevention trials for adults with DS.
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | Recruiting |
| University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only | Orange | California | Recruiting |
| Linda Crnic Institute for Down Syndrome, University of Colorado | Aurora | Colorado | Recruiting |
| Advocate Medical Group Adult Down Syndrome Center | Park Ridge | Illinois | Not Yet Recruiting |
| Indiana University | Indianapolis | Indiana | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| University of Kentucky, Co-Enrolling through ABC-DS Only | Lexington | Kentucky | Recruiting |
| Massachusetts General Hospital, Co-Enrolling through ABC-DS Only | Boston | Massachusetts | Recruiting |
| Washington University, St. Louis | St Louis | Missouri | Recruiting |
| Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas | Las Vegas | Nevada | Not Yet Recruiting |
| New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only | Staten Island | New York | Recruiting |
| Case Western Reserve University | Beachwood | Ohio | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Not Yet Recruiting |
| Oregon Health & Science University | Portland | Oregon | Not Yet Recruiting |
| University of Pittsburgh, Co-Enrolling through ABC-DS Only | Pittsburgh | Pennsylvania | Recruiting |
| Vanderbilt University Medical Center Center for Cognitive Medicine | Nashville | Tennessee | Recruiting |
| University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases | San Antonio | Texas | Recruiting |
| University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only | Madison | Wisconsin | Recruiting |
| Institut Jerome Lejeune | Paris | France | Recruiting |
| Institute of Memory & Cognition, Tallaght University Hospital | Dublin | Ireland | Recruiting |
| Sant Pau Biomedical Research Institute (IIB Sant Pau) | Barcelona | Spain | Recruiting |
| University of Cambridge, Co-Enrolling through ABC-DS Only | Cambridge | United Kingdom | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04165109 on ClinicalTrials.gov ↗ ← All trials in France