Collaboration for Down Syndrome Progress (CDP)
CDP
The INCLUDE (INvestigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome) Project's Collaboration for Down Syndrome Progress (CDP) Program
8 other identifiers
observational
1,400
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
June 4, 2026
May 1, 2026
3.3 years
May 11, 2026
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Enrollment of Participants into the DS-CDP Common Protocol
The primary aim of the DS-CDP is enrollment of up to 1,400 participants with Down syndrome across the lifespan into the Common Protocol to support future cross-sectional and longitudinal research
4 years
Study Arms (1)
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.
Eligibility Criteria
The CDP is enrolling individuals with Down syndrome of all ages and a small number of control participants without Down syndrome from a wide range of backgrounds, including variation in age, geographic location, and functional abilities. Included in enrollment for individuals with Down syndrome is a Support Person to assist in completion of some CDP activities.
You may qualify if:
- 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.
You may not qualify if:
- A participant will also be excluded if a healthcare professional determines that CDP involvement poses a risk of mental and physical harm to the participant.
- Known genetic conditions or syndromes with effects on neurobehavioral development (except for Down syndrome) such as Fragile X syndrome, Williams syndrome, or Prader-Willi syndrome. We may also exclude other syndromes such as Marfan's syndrome or Turner syndrome because of overall significant multisystem effects.
- Birth weight \< 2,000 grams or gestational age \< 34 weeks (infants with Down syndrome infants) or \<37 weeks (control subjects)
- Significant perinatal adversity, in utero neurotoxin exposure or maternal gestational diabetes requiring medication management
- Neurological event like a stroke
- Congenital infection associated with altered development (e.g., congenital rubella)
- Significant infection affecting the brain after birth, like meningitis
- In infants with Down syndrome, severe medical issues which may exert significant developmental effects beyond Down syndrome such as:
- Cyanotic cardiac abnormalities (e.g., Tetralogy of Fallot) that affect overall oxygen levels
- Frailty because of recovery from significant surgery or extended hospital stays
- Contraindication for MRI
- English not predominant home language
- Family history of a first-degree relative with psychosis or bipolar disorder (controls only)
- To be consistent with prior imaging studies from the infant brain imaging study, healthy controls will additionally be excluded for a family history of a first- or second-degree relative with ASD to also allow them to serve as a comparison group for elevated familial liability for ASD.
- Participants under the age of 12 who are currently being treated for obstructive sleep apnea using a positive airway pressure (PAP) device.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of California Irvine
Orange, California, 92868, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33136, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University in St. Louis
St Louis, Missouri, 63108, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15203, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Texas Children's Hosptial/Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antionio
San Antonio, Texas, 78207, United States
University of Washington
Seattle, Washington, 98195, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Related Links
Biospecimen
Biospecimens-including blood, saliva, and tongue swabs.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica E Hunter, PhD
RTI International
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Public Health
Study Record Dates
First Submitted
May 11, 2026
First Posted
June 4, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
June 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Ongoing, throughout the duration of the program
- Access Criteria
- Through the INCLUDE Data HUB
IPD will be available to other researchers through the INCLUDE Data Hub.