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Find more clinical trials

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

Start: June 2021
End: December 2025
Enrollment: 120

What Is This Study About?

The Trial-Ready Cohort - Down Syndrome (TRC-DS) study will enroll people with Down syndrome who have no symptoms of dementia to participate in future Alzheimer's disease prevention studies. TRC-DS participants will undergo cognitive and clinical assessments, genetic and biomarker testing, and brain imaging and other tests. Researchers will analyze this information to improve methods for tracking Alzheimer's disease progression. During the study, TRC-DS researchers may refer participants to other studies, including the Alzheimer's Biomarkers Consortium-Down Syndrome (ABC-DS) study. Participation in any of these other studies is always optional.

Do I Qualify To Participate in This Study?

Minimum Age: 25 Years

Maximum Age: 55 Years

Must have:

  • Diagnosis of Down syndrome, based on karyotype genetic testing or medical records
  • Available for the duration of this study (16 months) or until referred and enrolled in another clinical trial
  • Good general health with no dementia diagnosis
  • If taking medications that affect the central nervous system, dosing must be stable for at least four weeks prior to study screening; if taking new medications, the study medical team will review to recommend timing for initial cognitive testing
  • Adequate vision and hearing to complete neuropsychological testing
  • Mental age of four years or greater and IQ > 40, based upon the Kaufman Brief Intelligence Test, Second Edition or medical records
  • Speak English or Spanish fluently
  • Availability of a reliable study partner (e.g., caregiver, sibling, parent) who is able to provide information about the participant's health, symptoms, and history
  • Able to provide informed consent or have a legally authorized representative

Must NOT have:

  • Any significant disease or unstable medical condition that could affect participation (e.g., unstable psychiatric disease, unstable heart condition or severe heart disease, chronic kidney failure, chronic liver disease)
  • Any condition that would make an MRI scan unsafe, such as metal implants (e.g., pacemaker, cochlear implant); metal fragments near the eyes or spinal cord (dental fillings do not present an MRI risk); morbid obesity; or claustrophobia
  • Currently breastfeeding or positive pregnancy test 48 hours prior to brain amyloid PET scan
  • History of a malignant disease in the past five years, with the exception of skin, cervical, or prostate cancer that has not spread
  • Any clinically significant abnormalities in screening laboratory tests
  • Suicidal risk, based on interview and/or answers to Columbia-Suicide Severity Rating Scale questionnaire
  • For participants undergoing cerebrospinal fluid collection: any evidence of blood clotting or bleeding disorder, or currently taking an anti-clotting medication (e.g., warfarin) 
  • Current participation in another clinical trial that would overlap or interfere with this study; participation in the ABC-DS study is acceptable
 

Who Is the General Study Contact?

For more information and to enroll, visit the TRC-DS study website.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
Barrow Neurological Institute
Phoenix, AZ 85013
Recruiting
California
University of California, Irvine School of Medicine (co-enrolling through ABC-DS only)
Orange, CA 92868
Recruiting
Colorado
Linda Crnic Institute for Down Syndrome, University of Colorado
Aurora, CO 80045
Recruiting
Indiana
Indiana University
Indianapolis, IN 46202
Recruiting
Kansas
University of Kansas
Kansas City, KS 66160
Not yet recruiting
Kentucky
University of Kentucky (co-enrolling through ABC-DS only)
Lexington, KY 40504
Recruiting
Massachusetts
Massachusetts General Hospital (co-enrolling through ABC-DS only)
Boston, MA 02114
Recruiting
Missouri
Washington University, St. Louis (co-enrolling through ABC-DS only)
Saint Louis, MO 63108
Recruiting
New York
New York State Institute for Basic Research in Developmental Disabilities (SIBRDD) - (Co-enrolling through ABC-DS study only)
Staten Island, NY 10314
Recruiting
Ohio
Case Western Reserve University
Beachwood, OH 44122
Recruiting
Pennsylvania
University of Pittsburgh (co-enrolling through ABC-DS only)
Pittsburgh, PA 15213
Recruiting
Tennessee
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, TN 37212
Recruiting
Wisconsin
University of Wisconsin - Madison, Waisman Center (co-enrolling through ABC-DS study only)
Madison, WI 53705
Recruiting

Who Sponsors This Study?

Lead: University of Southern California

Source: ClinicalTrials.gov ID: NCT04165109

 

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An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health