Collaboration for Down Syndrome Progress (CDP)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRTI International
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,400 Participants
are grouped into 1 trial groupGroup A: CDP Down Syndrome Cohort
Trial outcomes
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
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
RTI International
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov