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

Sponsor: University of Southern California

NCT ID: NCT04165109

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 78 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the University of Southern California, is building a group of adults with Down syndrome who may be ready to take part in future clinical trials for Alzheimer's disease and dementia. It covers people with Down syndrome aged 25 to 55 who do not have a diagnosis of dementia. The study name is Trial-Ready Cohort-Down Syndrome (TRC-DS).

Who can take part

  • A confirmed diagnosis of Down syndrome (from genetic testing or medical records)
  • Aged 25 to 55, male or female
  • In good general health, with no diagnosis of dementia
  • Able and willing to follow all study procedures and stay available until referred to a clinical trial
  • Consent given by the person themselves, or by a legally authorised representative (with assent from the person if they cannot consent)
  • Any medicines affecting the brain must have been at a stable dose for at least 4 weeks
  • Good enough eyesight and hearing to complete memory and thinking tests
  • A mental age of 4 years or above, based on a short thinking test (Kaufman Brief Intelligence Test, Second Edition) or medical records
  • An IQ score of 40 or more on this test
  • Speaks English or Spanish fluently
  • Has a reliable study partner (such as a carer, sibling or parent) who can give accurate information about the person's symptoms and history

Who may not be able to

  • Any serious or unstable illness that could affect taking part (for example unstable mental illness, heart problems, long-term kidney or liver disease, or severe lung disease)
  • Unable to have an MRI (magnetic resonance imaging) scan, for example because of a pacemaker, certain metal fragments, or a cochlear implant
  • Unable to complete the MRI procedure
  • A history of cancer in the last 5 years, apart from certain treated skin cancers and some other cancers that were fully treated
  • Unusual blood test results for vitamin B12 or thyroid function that could affect the study (unless further tests show they are not a problem)
  • Other significant problems found in screening blood tests
  • For those giving a sample of fluid from around the spine (CSF): a bleeding or clotting disorder, abnormal clotting blood tests, or taking blood-thinning medicines such as warfarin
  • Taking part in another trial of an experimental product, or another long-term study with overlapping tests (except the ABC-DS study, or if approved by the project director)
  • Any other reason the study team thinks means the person cannot take part

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team; participants must be available for the whole study or until they are referred to a clinical trial.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
25 Years to 55 Years
Who
All
Number of participants
550
Started
2021-06-07
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for down syndrome
  • • Clinical study - 550 participants
  • • 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

Who can take part?

  • • Ages 25 Years to 55 Years
  • • Diagnosed with down syndrome

Where?

  • • Cambridge - University of Cambridge, Co-Enrolling through ABC-DS Only

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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/.

Down SyndromeAlzheimer DiseaseDementia

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 25 Years - 55 Years
  • Who can join: All genders

What the study is looking for

  • ✓Diagnosis of DS (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21 or partial trisomy...
  • ✓Stated availability and willingness to comply with all study procedures and availability for the duration of the...
  • ✓Male or female, aged 25-55 inclusive
  • ✓In good general health as evidenced by medical history with no diagnosis of dementia
  • ✓Adequate visual and auditory acuity to allow neuropsychological testing

Who cannot take part

  • ✗Participants unable to complete MRI procedure
  • ✗Clinically significant abnormalities in screening laboratories
  • ✗For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal...
See the full criteria
Inclusion Criteria: 1. 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) 2. 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). 3. 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 4. Male or female, aged 25-55 inclusive 5. In good general health as evidenced by medical history with no diagnosis of dementia 6. 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 7. Adequate visual and auditory acuity to allow neuropsychological testing 8. 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) 9. Ability to complete KBIT-2 with IQ equal to or greater than 40 10. Must speak English or Spanish fluently 11. 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 Exclusion Criteria: 1. 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) 2. 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) 3. Participants unable to complete MRI procedure 4. 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 5. 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. 6. Clinically significant abnormalities in screening laboratories 7. 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) 8. 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 9. 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 Is This Study? (1 UK site)

University of Cambridge, Co-Enrolling through ABC-DS Only

Cambridge CB2 1TN, United Kingdom

Recruiting
Site contact (verified)
Shahid Zaman, MD, PhDPrincipal Investigator

How to Get in Touch

ATRI Recruitment Team

Sponsor contact

CONTACT

213-821-0569 DS-participate@usc.edu
Data sourced from ClinicalTrials.gov · Last verified: 2026-05