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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor: University of Southern California
Study ID: NCT04165109
Status: Recruiting

Conditions

Alzheimer Disease
Dementia
Down Syndrome

Eligibility Criteria

Sex: ALL
Age: 25 Years - 55 Years
Healthy Volunteers: Not accepted

Study Details

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/.

Key Dates

Start date: Jun 7, 2021
Status verified: May 2026
Primary completion: Dec 31, 2027
Completion: Dec 31, 2027

Study Design

Enrollment: 550 participants (estimated)

Arms

Arm: Trial Ready Cohort
Non-demented adults with Down syndrome (DS)

Primary Outcome Measure

Enrollment of participants into the Trial-Ready Cohort in DS (TRC-DS). [ Time Frame: 5 years ]

Central Contacts

ATRI Recruitment Team
213-821-0569
[email protected]

Locations (18)

Facility	City	State	ZIP	Site coordinators
Barrow Neurological Institute	Phoenix	Arizona	85013	Anna Burke, MD (PRINCIPAL_INVESTIGATOR)
University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only	Orange	California	92868	Ira Lott (PRINCIPAL_INVESTIGATOR)
Linda Crnic Institute for Down Syndrome, University of Colorado	Aurora	Colorado	80045	Joaquin Espinosa, PhD (PRINCIPAL_INVESTIGATOR)
Advocate Medical Group Adult Down Syndrome Center	Park Ridge	Illinois	60068	Brian Chicoine, MD (PRINCIPAL_INVESTIGATOR)
Indiana University	Indianapolis	Indiana	46202	Jill Fodstad, PhD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical Center	Kansas City	Kansas	66160	Lauren T Ptomey, PhD, RD, LD (PRINCIPAL_INVESTIGATOR)
University of Kentucky, Co-Enrolling through ABC-DS Only	Lexington	Kentucky	40504	Frederick Schmitt, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital, Co-Enrolling through ABC-DS Only	Boston	Massachusetts	02114	Herminia Herminia Diana Rosas (PRINCIPAL_INVESTIGATOR)
Washington University, St. Louis	St Louis	Missouri	63108	Beau Ances, MD, PhD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas	Las Vegas	Nevada	89106	Charles Bernick, MD (PRINCIPAL_INVESTIGATOR)
New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only	Staten Island	New York	10314	Sharon Krinsky-McHale, PhD (PRINCIPAL_INVESTIGATOR)
Case Western Reserve University	Beachwood	Ohio	44122	Rajeet Shrestha, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati	Cincinnati	Ohio	45219	Russell Sawyer, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science University	Portland	Oregon	97239	Aimee Pierce, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh, Co-Enrolling through ABC-DS Only	Pittsburgh	Pennsylvania	15213	Benjamin Handen (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical Center Center for Cognitive Medicine	Nashville	Tennessee	37212	Paul Newhouse, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases	San Antonio	Texas	78229	Sarah Savoia, PAC-C (PRINCIPAL_INVESTIGATOR)
University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only	Madison	Wisconsin	53705	Bradley Christian (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition

Alzheimer's disease

By specialty

Neurology Dementia care Brain disorders Geriatrics

By research site

Barrow Neurological Institute· Phoenix, AZ University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only· Orange, CA Linda Crnic Institute for Down Syndrome, University of Colorado· Aurora, CO Advocate Medical Group Adult Down Syndrome Center· Park Ridge, IL Indiana University· Indianapolis, IN University of Kansas Medical Center· Kansas City, KS

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