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Trial-Ready Cohort-Down Syndrome (TRC-DS)
NCT04165109 · View on ClinicalTrials.gov ↗
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 450 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/.
Conditions Studied
Study Locations (20)
Ohio
- Case Western Reserve University — Beachwood
- University of Cincinnati — Cincinnati
Other
- Sant Pau Biomedical Research Institute (IIB Sant Pau) — Barcelona
- University of Cambridge, Co-Enrolling through ABC-DS Only — Cambridge
Arizona
- Barrow Neurological Institute — Phoenix
California
- University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only — Orange
Colorado
- Linda Crnic Institute for Down Syndrome, University of Colorado — Aurora
Illinois
- Advocate Medical Group Adult Down Syndrome Center — Park Ridge
Indiana
- Indiana University — Indianapolis
Kansas
- University of Kansas Medical Center — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2027-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04165109
The ClinicalTrials.gov registry entry for NCT04165109 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04165109 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Ohio, Other, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04165109 about?
NCT04165109 is a clinical study titled "Trial-Ready Cohort-Down Syndrome (TRC-DS)". 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 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS...
What is the current status of trial NCT04165109?
This trial is currently recruiting. The enrollment target is 450 participants. The study started on 2021-06-07. Estimated completion is 2027-12-31.
What conditions does trial NCT04165109 study?
This clinical trial studies the following conditions: Alzheimer Disease, Dementia, Down Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04165109?
This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04165109 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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