Down Syndrome Clinical Trials

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The INCLUDE (INvestigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome) Project's Collaboration for Down Syndrome Progress (CDP) Program

Status: Recruiting
Location: See all (16) locations...
Study Type: Observational
SUMMARY

The Collaboration for Down Syndrome Progress (CDP) is a long-term study that follows people with Down syndrome of all ages. The goal is to better understand their health, development, and everyday experiences over time. Participants and their caregivers will answer questions, share medical information, and may give samples like blood or saliva. Some participants may also take part in optional activities such as sleep studies, movement tracking, or brain imaging. By collecting the same types of information at many sites, the CDP will help researchers learn why certain health conditions are more common in people with Down syndrome and how to improve care and quality of life.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Individual with Down syndrome

⁃ To be considered potentially eligible for this CDP, a participant must meet the following criteria:

• Diagnosis of Down syndrome (with the exception of control participants for the Subsample study on Imaging). We will be enrolling participants with all types of Down syndrome including standard Trisomy 21, mosaic Down syndrome, and translocations.

• Primary language is English, Spanish, or Portuguese.

⁃ Support Person

• Able to attend in-person or remote visits.

• Able to provide accurate information about the study participant's clinical outcomes and family history.

• Primary language is English, Spanish, or Portuguese.

⁃ Biological parent(s) biospecimen collection

• Biological parent of the enrolled participant.

• Willing to provide a biological sample.

• Primary language is English, Spanish, or Portuguese. Imaging subsample study controls

• A subset of controls will be enrolled to match a cohort of individuals who take part in the CDP Subsample Study on imaging. Healthy control infants must be born at greater than 36 weeks gestational age and must have at least one older sibling. The sibling criterion allows comparability for potential analyses combining control data from DS-CDP with analogous control data previously collected by IBIS for other neurodevelopmental studies.

Locations
United States
California
University of California Irvine
NOT_YET_RECRUITING
Orange
Colorado
University of Colorado Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
Florida
University of Miami
NOT_YET_RECRUITING
Miami
Kansas
Kansas University Medical Center
NOT_YET_RECRUITING
Kansas City
Maryland
John Hopkins University
NOT_YET_RECRUITING
Baltimore
Minnesota
University of Minnesota
NOT_YET_RECRUITING
Minneapolis
Missouri
Washington University in St. Louis
NOT_YET_RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Pennsylvania
The Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
The Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
University of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
Tennessee
St. Jude Children's Research Hospital
NOT_YET_RECRUITING
Memphis
Texas
Texas Children's Hosptial/Baylor College of Medicine
NOT_YET_RECRUITING
Houston
University of Texas Health Science Center at San Antionio
NOT_YET_RECRUITING
San Antonio
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Contact Information
Primary
Jessica E Hunter, PhD
jehunter@rti.org
919 541 6000
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 1400
Treatments
CDP Down Syndrome Cohort
Individuals with Down syndrome enrolled in the CDP Common Protocol. Participants complete standardized questionnaires, neurobehavioral assessments, medical examinations, and biospecimen collection. Medical records are reviewed, and data are harmonized across all sites. A subset of CDP participants may participate in sleep studies, activity monitoring, imaging and metabolic/endocrine blood collection.
Related Therapeutic Areas
Sponsors
Leads: RTI International
Collaborators: National Institute on Aging (NIA), National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov