Study

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

Eligibility Requirements:

You may be eligible for TRC-DS if you meet the following criteria:

  1. Diagnosis of Down syndrome
  2. Male or female, aged 35-55 years
  3. In good general health; with no diagnosis of dementia
  4. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer
  5. Adequate visual and auditory acuity to allow neuropsychological testing
  6. Mental Age of 4 years or greater
  7. IQ greater than 40
  8. Must speak English or Spanish fluently
  9. Must have a reliable Study Partner (may be caregiver, sibling, parent) who can provide correct information about the participant’s clinical symptoms and history

Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director.

About the Study:

Alzheimer’s disease (AD) is the primary cause of death in adults with Down syndrome (DS) over the age of 35, highlighting the pressing need for the inclusion of individuals with DS in clinical trials for AD. The Trial- Ready Cohort- Down Syndrome (TRC-DS) focuses on adults with DS TRC-DS matches people with DS to AD clinical trials specifically designed for people with DS. Volunteers become part of a community of clinical trial volunteers who can help find a cure for Alzheimer’s. TRC-DS routinely monitors volunteers for any changes to their brain health or function over time through blood tests and brain imaging to eventually match them with applicable AD clinical trials. Through routine screenings, researchers can fast-track TRC-DS volunteers for enrollment in qualifying clinical studies as soon as they are eligible and matched with one.

Purpose:

The purpose of TRC-DS is to enroll 120 non-demented adults with DS (ages 35-55) across 15 sites to determine longitudinal cognitive, clinical and biomarker trajectories in the cohort and accelerate enrollment into clinical trials. People with DS helped researchers discover the genetic connection between chromosome 21, amyloid and AD almost 40 years ago. Researchers want to bring the latest therapies to people with DS who helped early Alzheimer’s research discoveries. TRC-DS is recruiting younger individuals because people with DS develop Alzheimer’s much earlier than others who develop the disease. If research could uncover ways to slow or prevent the progression of AD in people with DS, especially at an earlier age, it could also show how to target AD in others.

What is Involved:

If you meet the inclusion criteria for the study, as discussed with your closest research site, the study entails 3 visits: screening, baseline, and month 16. 


  1. Screening Visit:
    1. Provision of signed and dated informed consent form; this includes adults with DS who can provide consent, at the baseline visit, or for whom a Legally Authorized Representative (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 LAR.
    2. Stated availability and willingness to comply with all study procedures and availability for the duration of the study (i.e. 2 years) or until referred to a clinical trial
    3. Biospecimen collection, MRI, and neuropsychological assessments
  2. Baseline Visit
    1. Neuropsychological assessments, biospecimen collection, lumbar puncture, and PET scan
  3. Month 16 visit
    1. Neuropsychological assessments, biospecimen collection, lumbar puncture, MRI and PET scan
 SELECT A SITE BELOW  

Back to Results

Age:
35 to 55
Duration:
2+ years
Visits:
3
Study Type:
Observational Studies; Studies for People without Memory Impairment

Study Site Locations: