Down SyndromeCDPNCT07625579
Collaboration for Down Syndrome Progress (CDP)
An observational study of Down Syndrome and Chromosome Disorders, run by RTI International at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Down Syndrome, Chromosome Disorders, Intellectual and Developmental Disabilities
- How many people
- 1,400 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 May 2026to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
- Imaging subsample study exclusion criteria for individuals with Down syndrome and controls:
- 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.
Show all 19Show fewer
- 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.
- Sleep subsample study exclusion criteria:
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Not yet recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Joaquin Espinosa, PhD, 303-724-7389
- Not yet recruiting
John Hopkins University
Baltimore, Maryland, 21287
Sheela N Magge, MD, MSCE, 443-997-5437, smagge3@jhmi.edu
- Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Heather Hazlett, PhD, 919-966-4099, cody@ad.unc.edu
- Not yet recruiting
Texas Children's Hosptial/Baylor College of Medicine
Houston, Texas, 77030
Mirjana Maletic-Savatic, MD, PhD, (832) 822-1700, maletics@bcm.edu
- Not yet recruiting
Kansas University Medical Center
Kansas City, Kansas, 66160
Lauren T Ptomey, PhD, RD, LD, 913-588-5000, lptomey@kumc.edu
- Recruiting
University of Wisconsin-Madison
Madison, Wisconsin, 53705
Sigan Hartley, PhD, 608.263.1656, slhartley@wisc.edu
- Not yet recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Lisa Jacola, PhD, ABPP-CN, 901-595-5042, Lisa.Jacola@STJUDE.org
- Not yet recruiting
University of Miami
Miami, Florida, 33136
Ignacio Tapia, MD, MS, 305-243-6641, itapia@miami.edu
- Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jason Wolff, PhD, 612-625-4166, jjwolff@umn.edu
- Not yet recruiting
University of California Irvine
Orange, California, 92868
Christy L Hom, PhD, 714-456-5902
- Not yet recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Andrea Kelly, MD, MSCE, 215-590-3174, kellya@chop.edu
- Not yet recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Juhi Pandey, PhD, 215-590-7555, pandeyj@chop.edu
- Not yet recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15203
Bejamin L Handen, PhD, 412-235-5445 Expertise, handenbl@upmc.edu
- Not yet recruiting
University of Texas Health Science Center at San Antionio
San Antonio, Texas, 78207
Maria Rayas, MD, 210-358-5437, rayas@uthscsa.edu
- Not yet recruiting
University of Washington
Seattle, Washington, 98195
Stephen Dager, MD, 877-408-UWAC, srd@uw.edu
- Not yet recruiting
Washington University in St. Louis
St Louis, Missouri, 63108
Natasha Marrus, MD, 314-286-1700, natasha@wustl.edu
About this study
Official title: The INCLUDE (INvestigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome) Project's Collaboration for Down Syndrome Progress (CDP) Program
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.
Read the detailed description
The Collaboration for Down Syndrome Progress (CDP) is a multisite, prospective longitudinal cohort designed to systematically characterize health, neurodevelopmental, neurobehavioral, and biological trajectories in individuals with Down syndrome across the lifespan. The CDP establishes a harmonized data collection framework implemented across U.S. and international clinical research sites to generate a large, integrated dataset suitable for cross-sectional and longitudinal analyses.
Participants undergo standardized assessments that include medical history, neurobehavioral evaluations, physical examinations, and review of electronic health records. Biospecimens-including blood, saliva, and tongue swabs-are collected to support genomic, transcriptomic, proteomic, metabolomic, and microbiome analyses. These samples are processed and stored within the Down Syndrome Biorepository for current and future research use.
The CDP also incorporates several optional subsample studies that provide deeper phenotyping in key domains relevant to co-occurring conditions in Down syndrome. These include home sleep apnea testing, wearable activity monitoring, neuroimaging using MRI, and metabolic and endocrine laboratory profiling. Each subsample follows additional standardized procedures to ensure comparability across sites.
All data generated through the CDP are curated and transferred to the NIH INCLUDE Data Hub, where they are made available in de identified form to qualified researchers. The resulting dataset is intended to advance understanding of co-occurring conditions, identify risk and resilience factors, and inform the development of evidence-based clinical practices and future therapeutic interventions for individuals with Down syndrome.
- Keywords
- Down syndrome
- Medical subject headings
- Down Syndrome, Chromosome Disorders, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 May 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jessica Ezzell Hunter, RTI International
- Investigators
- Jessica E Hunter, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625579
- Sponsor's protocol ID
- DS-4C (36648)
- Other IDs
- 1U54HL178351, 1U01HD116485, 1U01HD116470, 1U01HD116469, 1U01HD116477, 1U01HD116463, 1U24AG092191
- Acronym
- CDP
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available to other researchers through the INCLUDE Data Hub.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INCLUDE (INvestigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome) Project's Collaboration for Down Syndrome Progress (CDP) Program
- ClinicalTrials.gov ID
- NCT07625579
- Acronym / sponsor ID
- CDP / DS-4C (36648)
- Keywords
- Down syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Aging (NIA)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Collaboration for Down Syndrome Progress (CDP) is a multisite, prospective longitudinal cohort designed to systematically characterize health, neurodevelopmental, neurobehavioral, and biological trajectories in individuals with Down syndrome across the lifespan. The CDP establishes a harmonized data collection framework implemented across U.S. and international clinical research sites to generate a large, integrated dataset suitable for cross-sectional and longitudinal analyses.
Participants undergo standardized assessments that include medical history, neurobehavioral evaluations, physical examinations, and review of electronic health records. Biospecimens-including blood, saliva, and tongue swabs-are collected to support genomic, transcriptomic, proteomic, metabolomic, and microbiome analyses. These samples are processed and stored within the Down Syndrome Biorepository for current and future research use.
The CDP also incorporates several optional subsample studies that provide deeper phenotyping in key domains relevant to co-occurring conditions in Down syndrome. These include home sleep apnea testing, wearable activity monitoring, neuroimaging using MRI, and metabolic and endocrine laboratory profiling. Each subsample follows additional standardized procedures to ensure comparability across sites.
All data generated through the CDP are curated and transferred to the NIH INCLUDE Data Hub, where they are made available in de identified form to qualified researchers. The resulting dataset is intended to advance understanding of co-occurring conditions, identify risk and resilience factors, and inform the development of evidence-based clinical practices and future therapeutic interventions for individuals with Down syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
- Imaging subsample study exclusion criteria for individuals with Down syndrome and controls:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enrollment of Participants into the DS-CDP Common Protocol
Time frame: 4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be available to other researchers through the INCLUDE Data Hub.
Related trials for Down Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica E Hunter, PhD principal investigator
RTI International
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Chromosome Disorders, run by RTI International at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica E Hunter, PhD (919 541 6000, jehunter@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of Participants into the DS-CDP Common Protocol (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.