Trial-Ready Cohort-Down Syndrome (TRC-DS)
Start: December 2020
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. Participation in any of these other studies is always optional.
Do I Qualify To Participate in This Study?
Minimum Age: 35 Years
Maximum Age: 55 Years
Must have:
- Diagnosis of Down syndrome (including mosaic Down syndrome or partial trisomy 21)
- 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 less than 40 (based upon the Kaufman Brief Intelligence Test, Second Edition)
- 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 study assessments (e.g., 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 electrocardiogram or 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
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information, 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 | |
|---|---|
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Barrow Neurological Institute
Phoenix, AZ 85013
Not yet recruiting
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| California | |
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University of California, Irvine School of Medicine
Orange, CA 92868
Not yet recruiting
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| Colorado | |
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Linda Crnic Institute for Down Syndrome, University of Colorado
Aurora, CO 80045
Not yet recruiting
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| Indiana | |
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Indiana University
Indianapolis, IN 46202
Recruiting
Katherine Britt |
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| Kentucky | |
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University of Kentucky
Lexington, KY 40504
Not yet recruiting
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| Massachusetts | |
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Massachusetts General Hospital
Boston, MA 02114
Not yet recruiting
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| Missouri | |
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Washington University, St. Louis
Saint Louis, MO 63108
Not yet recruiting
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| New York | |
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New York State Institute for Basic Research in Developmental Disabilities (SIBRDD)
Staten Island, NY 10314
Not yet recruiting
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| Ohio | |
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Case Western Reserve University
Beachwood, OH 44122
Not yet recruiting
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| Pennsylvania | |
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University of Pittsburgh
Pittsburgh, PA 15213
Not yet recruiting
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| Tennessee | |
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Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, TN 37212
Recruiting
Amy Boegel |
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Who Sponsors This Study?
Lead: University of Southern California
Source: ClinicalTrials.gov ID: NCT04165109