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NCT04165109 · ClinicalTrials.gov registry record

Trial-Ready Cohort-Down Syndrome (TRC-DS)

A clinical trial of Alzheimer Disease and Dementia, sponsored by University of Southern California.

Recruiting
Registry status
450
Enrollment target
20
Study locations

NCT04165109: Recruiting study of Alzheimer Disease and Dementia, sponsored by University of Southern California.

NCT04165109 is a study of Alzheimer Disease and Dementia that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 450 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04165109, a study of Alzheimer Disease and Dementia, is actively recruiting participants, sponsored by University of Southern California.

RECRUITING
Registry status
450 participants
Enrollment target
20
Study locations

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/.

Primary Outcome

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.

Conditions Studied

Alzheimer Disease Dementia Down Syndrome

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

FieldValue
Enrollment Target 450 participants
Start Date 2021-06-07
Est. Completion 2027-12-31
University of Southern California

617 total trials

What NCT04165109 shows while recruiting

NCT04165109 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (84% lower).

The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 0 interventions.

NCT04165109 names 20 study sites across 18 states, led by Ohio, Other, Arizona.

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.

Who is sponsoring clinical trial NCT04165109?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Alzheimer Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04165109's enrollment target sits among peer trials

450 58th of 306 higher than 248 of 306 other Alzheimer Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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More recruiting context for NCT04165109

Source: ClinicalTrials.gov NCT04165109, the US trial registry maintained by the National Library of Medicine. NCT04165109 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.