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

Recruiting now

Conditions studied: Down Syndrome, Alzheimer Disease, Dementia

In brief

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/.

Key facts

Study ID: NCT04165109
Run by: University of Southern California
People needed: 550
Starts: 2021-06-07
Expected to finish: 2027-12-31
Last updated by the study team: 2026-05-18

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of DS (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21 or partial trisomy 21) (as confirmed by genetic testing or medical record review)
Provision of signed and dated informed consent form; this includes adults with DS who can provide consent, or for whom an LAR provides consent on behalf of the individual to participate. Adults with DS who cannot consent must sign and date an assent accompanied with a signed and dated consent by legally authorized representative (LAR).
Stated availability and willingness to comply with all study procedures and availability for the duration of the study or until referred to a clinical trial
Male or female, aged 25-55 inclusive
In good general health as evidenced by medical history with no diagnosis of dementia
Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, medical monitoring team will review on case by case basis to recommend timing of baseline cognitive testing
Adequate visual and auditory acuity to allow neuropsychological testing
Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, Second Edition, KBIT-2, verbal age equivalent, or based upon medical records)
Ability to complete KBIT-2 with IQ equal to or greater than 40
Must speak English or Spanish fluently
Must have a reliable Study Partner (may be caregiver, sibling, parent) who is capable of providing correct information about the participant's clinical symptoms and history

You may not qualify if…

Any significant disease or unstable medical condition that could affect participation (i.e., unstable psychiatric disease, unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a non-compatible pacemaker, presence of MRI-incompatible metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI)
Participants unable to complete MRI procedure
History, within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. A high TSH is exclusionary unless follow up T3/T4 levels indicate that it is not physiologically significant.
Clinically significant abnormalities in screening laboratories
For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation therapy (e.g. warfarin)
Concurrent participation in a clinical trial for an investigational product or concurrent participation in longitudinal study with overlapping outcome measures/procedures is prohibited with the exception of ABC-DS co-enrollment or as approved by project director
Participants whom the investigator deems to be otherwise ineligible. The Investigators should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC-DS would be appropriate

Where it is running

University of Cambridge, Co-Enrolling through ABC-DS Only — Cambridge, United Kingdom (enrolling)
University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only — Orange, California, United States (enrolling)
Linda Crnic Institute for Down Syndrome, University of Colorado — Aurora, Colorado, United States (enrolling)
Institut Jerome Lejeune — Paris, France, France (enrolling)
Institute of Memory & Cognition, Tallaght University Hospital — Dublin, Ireland, Ireland (enrolling)
Sant Pau Biomedical Research Institute (IIB Sant Pau) — Barcelona, Spain (enrolling)
Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
Indiana University — Indianapolis, Indiana, United States (enrolling)
University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
University of Kentucky, Co-Enrolling through ABC-DS Only — Lexington, Kentucky, United States (enrolling)
Massachusetts General Hospital, Co-Enrolling through ABC-DS Only — Boston, Massachusetts, United States (enrolling)
Washington University, St. Louis — St Louis, Missouri, United States (enrolling)
New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only — Staten Island, New York, United States (enrolling)
Case Western Reserve University — Beachwood, Ohio, United States (enrolling)
University of Pittsburgh, Co-Enrolling through ABC-DS Only — Pittsburgh, Pennsylvania, United States (enrolling)
Vanderbilt University Medical Center Center for Cognitive Medicine — Nashville, Tennessee, United States (enrolling)
University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases — San Antonio, Texas, United States (enrolling)
University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only — Madison, Wisconsin, United States (enrolling)
Advocate Medical Group Adult Down Syndrome Center — Park Ridge, Illinois, United States
University of Cincinnati — Cincinnati, Ohio, United States
Oregon Health & Science University — Portland, Oregon, United States
Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.