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Understanding Alzheimer's Disease in Down Syndrome

This observational study, called TRC-DS, aims to better understand how Alzheimer's disease (AD) develops in adults with Down syndrome (DS). Researchers will enroll up to 550 participants, including 120 healthy adults with Down syndrome aged 25-55. The study will involve regular assessments of thinking and memory, genetic and biomarker (biological signs) testing, imaging (like MRI scans), and collecting biological samples. The goal is to find reliable ways to measure AD progression in people with DS, which will help design future clinical trials for new treatments. This study does not test any specific drug or intervention.

Study design
This is an observational study aiming to enroll up to 550 participants. It is not testing a specific treatment, but rather collecting information over time.
What's involved
Participants will undergo longitudinal cognitive and clinical assessments, genetic and biomarker testing, imaging, and biospecimen collection. The duration of these commitments is not specified, but the primary endpoint is measured at 5 years.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for enrollment is measured at 5 years, suggesting a long-term follow-up period.

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NCT04165109

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

Recruiting
Not specifiedAges 25–55Observational
University of Southern California
~550 participants
Updated 2026-05-18 on ClinicalTrials.gov

At a glance

Recruiting sites
18 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enrollment of participants into the Trial-Ready Cohort in DS (TRC-DS).
Measured over 5 years

Conditions

Down Syndrome
Alzheimer Disease
Dementia

Explore related trials

Alzheimer's DiseaseDown Syndrome

Where it's being run

22 sites across 21 states
Ohio2
Arizona1
California1
Colorado1
Illinois1
Indiana1
Kansas1
Kentucky1

Study leadership

  • Michael Rafii, MD, PhD · PRINCIPAL_INVESTIGATOR · USC Alzheimer's Therapeutic Research Institute (ATRI)

Who to contact

ATRI Recruitment Team
[email protected]
213-821-0569
Email the study team

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What this trial measures

  • 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.