Collaboration for Down Syndrome Progress (CDP)

The Collaboration for Down Syndrome Progress (CDP) is a long-term observational study that aims to better understand the health, development, and daily experiences of people with Down syndrome of all ages. This study is not testing a new medicine or treatment. You or your family member with Down syndrome would share medical information, answer questions, and might provide samples like blood or saliva. Some participants can also choose to do optional activities such as sleep studies or brain imaging. The goal is to collect information from many people to learn why certain health conditions are common in Down syndrome and how to improve care and quality of life. The study plans to enroll 1400 participants.

Study design: This is an observational study, meaning it collects information without providing an intervention. It plans to enroll 1400 participants.
What's involved: Participants will undergo standardized assessments including medical history, evaluations, physical exams, and review of health records. Biospecimens (blood, saliva, tongue swabs) will be collected, and there are optional subsample studies like sleep testing or MRI.
Compensation: Not stated in the trial record.
Follow-up: The primary goal is the enrollment of participants into the study, measured at 4 years. The study is designed to follow individuals across their lifespan.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Collaboration for Down Syndrome Progress (CDP)

Recruiting

Not specifiedAll AgesObservational

RTI International

~1,400 participants

Updated 2026-06-04 on ClinicalTrials.gov

At a glance

Recruiting sites

1 of 16 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Enrollment of Participants into the DS-CDP Common Protocol

Measured over 4 years

Conditions

Down Syndrome

Chromosome Disorders

Intellectual and Developmental Disabilities

Where it's being run

16 sites across 13 states

Pennsylvania3

Texas2

California1

Colorado1

Florida1

Kansas1

Maryland1

Minnesota1

Study leadership

Jessica E Hunter, PhD · PRINCIPAL_INVESTIGATOR · RTI International

Who to contact

Jessica E Hunter, PhD

[email protected]

919 541 6000

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individual with Down syndrome

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.

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 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.

Exclusion

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

Significant medical conditions (unrelated to Down syndrome) affecting growth, development, cognition or sensory impairments. We will conduct a review of the medical history to identify major medical conditions that might be a reason for exclusion.

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.

For the WatchPAT device, participants must weigh more than 65 pounds. They cannot have a permanent pacemaker or sustained non-sinus cardiac arrhythmias.

What this trial measures

Enrollment of Participants into the DS-CDP Common Protocol4 years
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

Trialytics