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Trial Ready Cohort for Alzheimer's Disease (TRC-DS Trial)

N/A
Recruiting
Led By Michael Rafii, MD, PhD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

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 450 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/.

Eligible Conditions
  • Alzheimer's Disease
  • Dementia
  • Down Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrollment of participants into the Trial-Ready Cohort in DS (TRC-DS).
Secondary outcome measures
Change in behavior as measured by the Neuropsychiatric Inventory (NPI)
Change in behavior as measured by the Vineland 3 (Informant Version)
Change in cognition as measured by the Cued Recall Test
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trial Ready CohortExperimental Treatment3 Interventions
Non-demented adults with Down syndrome (DS)

Find a Location

Who is running the clinical trial?

Alzheimer's Therapeutic Research InstituteOTHER
17 Previous Clinical Trials
57,775 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,553 Total Patients Enrolled
Alzheimer's Clinical Trials ConsortiumOTHER
4 Previous Clinical Trials
2,310 Total Patients Enrolled
~119 spots leftby Dec 2025