Actively Recruiting
Trial-Ready Cohort-Down Syndrome (TRC-DS)
Led by University of Southern California · Updated on 2026-04-06
550
Participants Needed
22
Research Sites
342 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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/.
CONDITIONS
Official Title
Trial-Ready Cohort-Down Syndrome (TRC-DS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Down syndrome confirmed by genetic testing or medical records
- Signed informed consent by participant or legally authorized representative; assent by participant if unable to consent
- Willingness and availability to follow all study procedures and participate for the study duration or until referral to a clinical trial
- Male or female aged 25 to 55 years inclusive
- Good general health with no diagnosis of dementia
- Stable dose of permitted CNS-active medications for at least 4 weeks or reviewed by medical monitoring team
- Adequate vision and hearing for neuropsychological testing
- Mental age of 4 years or greater based on KBIT-2 verbal age equivalent or medical records
- Ability to complete KBIT-2 with IQ of 40 or greater
- Fluent in English or Spanish
- Has a reliable study partner such as caregiver, sibling, or parent able to provide accurate clinical information
You will not qualify if you...
- Significant or unstable medical conditions affecting participation (unstable psychiatric disease, cardiac problems, chronic renal or hepatic disease, severe pulmonary disease)
- Contraindications to MRI including incompatible pacemaker, metallic fragments near eyes or spine, or cochlear implant
- Unable to complete MRI procedure
- History in last 5 years of primary or recurrent malignant disease except certain skin and in situ cancers
- Clinically significant abnormalities in vitamin B12 or thyroid function tests unless follow-up tests show no physiological significance
- Abnormal screening laboratory results
- For CSF collection: blood clotting or bleeding disorders, abnormal clotting times, or use of anticoagulant therapy
- Concurrent participation in other clinical trials or longitudinal studies with overlapping procedures except ABC-DS co-enrollment or approved exceptions
- Any other factors deemed by investigator to make participant ineligible for future clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only
Orange, California, United States, 92868
Actively Recruiting
3
Linda Crnic Institute for Down Syndrome, University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Advocate Medical Group Adult Down Syndrome Center
Park Ridge, Illinois, United States, 60068
Not Yet Recruiting
5
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
University of Kentucky, Co-Enrolling through ABC-DS Only
Lexington, Kentucky, United States, 40504
Actively Recruiting
8
Massachusetts General Hospital, Co-Enrolling through ABC-DS Only
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Washington University, St. Louis
St Louis, Missouri, United States, 63108
Actively Recruiting
10
Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas
Las Vegas, Nevada, United States, 89106
Not Yet Recruiting
11
New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only
Staten Island, New York, United States, 10314
Actively Recruiting
12
Case Western Reserve University
Beachwood, Ohio, United States, 44122
Actively Recruiting
13
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Not Yet Recruiting
14
Oregon Health & Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
15
University of Pittsburgh, Co-Enrolling through ABC-DS Only
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
16
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, United States, 37212
Actively Recruiting
17
University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas, United States, 78229
Actively Recruiting
18
University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only
Madison, Wisconsin, United States, 53705
Actively Recruiting
19
Institut Jerome Lejeune
Paris, France, France, 75018
Actively Recruiting
20
Institute of Memory & Cognition, Tallaght University Hospital
Dublin, Ireland, Ireland, 24
Actively Recruiting
21
Sant Pau Biomedical Research Institute (IIB Sant Pau)
Barcelona, Spain, 08041
Actively Recruiting
22
University of Cambridge, Co-Enrolling through ABC-DS Only
Cambridge, United Kingdom, CB2 1TN
Actively Recruiting
Research Team
A
ATRI Recruitment Team
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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