RecruitingNCT04165109

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

Alzheimer's Clinical Trial Consortium for Down Syndrome (ACTC-DS) Trial-Ready Cohort - Down Syndrome (TRC-DS)

Sponsor

University of Southern California

Enrollment

550 participants

Start Date

Jun 7, 2021

Study Type

OBSERVATIONAL

Conditions

Dementia Alzheimer Disease Down Syndrome

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 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/.

Eligibility

Min Age: 25 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is building a "trial-ready cohort" of adults with Down syndrome (DS) to prepare them for future clinical trials testing treatments for Alzheimer's disease. People with Down syndrome have a greatly elevated risk of developing Alzheimer's because of an extra copy of chromosome 21, which carries the gene for amyloid protein — a key driver of Alzheimer's. This observational study collects cognitive, genetic, and biomarker data over time. **You may be eligible if...** - You have been diagnosed with Down syndrome (trisomy 21, mosaic trisomy 21, Robertsonian translocation, or partial trisomy 21) confirmed by genetic testing - You are between 25 and 55 years old - You are in good general health - You or your legal representative can provide signed informed consent - You are willing to comply with all study visits and procedures **You may NOT be eligible if...** - You cannot comply with the study procedures or attend visits - Your Down syndrome diagnosis has not been confirmed by genetic testing or medical records Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(22)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only

Orange, California, United States

Linda Crnic Institute for Down Syndrome, University of Colorado

Aurora, Colorado, United States

Advocate Medical Group Adult Down Syndrome Center

Park Ridge, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

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

Lexington, Kentucky, United States

Massachusetts General Hospital, Co-Enrolling through ABC-DS Only

Boston, Massachusetts, United States

Washington University, St. Louis

St Louis, Missouri, United States

Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas

Las Vegas, Nevada, United States

New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only

Staten Island, New York, United States

Case Western Reserve University

Beachwood, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

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

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center Center for Cognitive Medicine

Nashville, Tennessee, United States

University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

San Antonio, Texas, United States

University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only

Madison, Wisconsin, United States

Institut Jerome Lejeune

Paris, France, France

Institute of Memory & Cognition, Tallaght University Hospital

Dublin, Ireland, Ireland

Sant Pau Biomedical Research Institute (IIB Sant Pau)

Barcelona, Spain

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

Cambridge, United Kingdom

View Full Details on ClinicalTrials.gov

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