Down SyndromeECODS-2NCT04208685
Evaluating Cognitive Outcomes in Down Syndrome
An observational study of Down Syndrome, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
As basic and behavioral science identify new ways to improve cognition and behavior in individuals with Down syndrome (DS), the lack of rigorous outcome measures represents an important problem for interpreting findings. Read more about this study
- Who is it for?
- Ages 6 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2018to 17 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be recruited from clinics at Cincinnati Children's Hospital Medical Center (CCHMC), community physicians, and the Jane and Richard Thomas Center for Down Syndrome at CCHMC, as well as from the community physicians, clinics, and DS clinic at CSU. In addition, the Down Syndrome Association of Greater Cincinnati (DSAGC) and the Rocky Mountain Down Syndrome Association (RMDSA) will publicize our study through social media and their mailing lists that reaches over 12,000 families combined. Subjects may also be recruited from community programs such as baseball teams, Special Olympics, etc.
Who may be able to join
- 6-35 years old at the time of consent.
- Documented diagnosis of DS.
- Nonverbal mental age of at least 36 months to complete assessment battery (per parent/caregiver/young adult self-report).
- Willingness to maintain stables dosages of current medication or ongoing treatment for the duration of the study to limit changes while evaluating outcome measures.
- Parent/caregiver/self-report that participant will be able to complete the study, including all visits.
Who cannot join
- History of blindness, deafness, or serious motor impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: Evaluating Cognitive Outcomes in Down Syndrome-2
As basic and behavioral science identify new ways to improve cognition and behavior in individuals with Down syndrome (DS), the lack of rigorous outcome measures represents an important problem for interpreting findings. Null findings in clinical trials could result from insensitive outcome measures, rather than ineffectiveness of treatment.
The long-term goal is to improve measurement of outcomes for children and adults with DS. Towards that goal, the investigators propose to test and refine a battery of cognitive measures that can be used in treatment studies focused on school-aged children and adults with Down syndrome. The batteries are designed to assess key domains of the DS phenotype where gaps remain in outcome measures, including attention, executive function, learning and memory, processing speed, and social cognition.
The investigators will examine the psychometric properties of measures (test-retest, validity, sensitivity to change), and to evaluate differences in the psychometric properties of measures as a function of variations in participant age, gender, degree of ID, and the participants' physical health and medical comorbidities. The investigators will evaluate at least 80 children and 50 adults with Down syndrome, per site, at five time points to evaluate key domains with a diverse and novel range of methods. This proposal aims to provide a preliminary evaluation to support the enhancement of clinical outcome measures, which ultimately will increase the accuracy in documenting improvements in the lives of children and young adults with Down syndrome.
Read the detailed description
The purpose of the proposed project is to test and refine a battery of cognitive measures that can be used in treatment studies focused on Down syndrome. The battery is designed to assess several key domains of the Down syndrome cognitive phenotype where gaps remain in outcome measures, including attention, executive function, learning and memory, processing speed, and social cognition, considering comorbid conditions that can potentially interfere with the development within these cognitive domains. Although a single battery for the entire lifespan of the individual with Down syndrome has obvious appeal, the investigators have focused their effort on the school-age years so that the investigators can capture a key time point in development of these cognitive domains. Moreover, new pharmaceutical treatments are transitioning from adults to the school-age population, making the need greatest for this portion of the lifespan.
However, based on preliminary research from the ongoing study with children, a need was identified to evaluate measures with young adults with DS (ages 18-39). Supplementary funding will support the expansion of the project to include young adults with DS. Results will provide empirical guidance for refining a battery and form the foundation for a larger-scale study evaluating outcome measures.
For participants 6-17 years, at least 160 children with Down syndrome will be recruited across two sites for the study, and participants will be enrolled over four (4) years. Following pre-screening and the consent visit to determine study eligibility, children will be assessed at 6 time points. The first assessment will be the baseline testing/Time 0 visit to assess IQ. At Time 1 baseline assessments for other functioning will be completed. A two-week interval will separate Time 1 and Time 2, at which time test-retest reliability assessments will be collected. Time 3 will occur three months following Time 2 to evaluate test sensitivity to change. Time 4 will occur 3 months following Time 3 and Time 5 will occur 6 months after Time 4 to assess longitudinal changes. The time interval was selected to replicate the duration of many clinical trials.
For participants 18-35 years, at least one hundred young adults aged 18-29 years with DS will be recruited across two sites to participate in the study. Adults will participate in neuropsychology assessments at 5 time points. Parents/Caregivers will complete behavioral measures at all time points. At Time 1 baseline assessments will be completed. A two-week interval (+/- 3 days) will separate Time 1 and Time 2, when test-retest reliability assessments will be collected. Time 3 will occur three months following Time 2 (+/- 2 weeks), Time 4 will occur three months following Time 3 (+/- 2 weeks), and Time 5 will occur 6 months following Time 4 (+/- 2 weeks) to evaluate sensitivity to change, Time 6 will occur 24 months following Time 1 (+/- 4 weeks), Time 7 will occur 36 months following Time 1 (+/- 4 weeks), and Time 8 will occur 48 months following Time 1 (+/- 4 weeks) to evaluate sensitivity to change. The three and six-month time intervals were selected to replicate the duration of many clinical trials. The 12-month interval was selected to provide a time interval in which natural development should occur and allow the investigators to evaluate sensitivity to change. In this study, change will occur due to natural development, while in a clinical trial, change would be expected due to treatment. The ability to detect relatively small developmentally-based change over 12 months will allow the investigators to evaluate if the measures could detect similarly small changes in trials. Once recruitment goals are met for NIH standards for 100 young adults, aged 18-29, the study team may begin recruiting adults who are 29-35, as well.
- Conditions
- Down Syndrome
- Medical subject headings
- Down Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of measures in the assessment battery, specifically establishing their test-retest reliability, validity, and sensitivity to change
Measured: Through study completion, an average of 4 years
Secondary outcomes (2)
Psychometric properties of the measures as a function of variations in participant age, gender, and degree of ID
Measured: Through study completion, an average of 4 years
Psychometric properties of the measures as a function of variations in the participants' physical health and medical comorbidities
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start18 Jun 2018
- Primary completion14 Jun 2024
- Study completion17 Jun 2024
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.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Sponsor
- Investigators
- Anna Esbensen, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208685
- Sponsor's protocol ID
- 2018-0253
- Acronym
- ECODS-2
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The shared databases and corresponding dataset generated for statistical analysis will include demographic information, standardized, experimental and computerized assessment data, and information from parent- and teacher-rating scales. The dataset will include all composite variables and scores, with no identifying information included. The data and associated documentation will be available to users only under a data sharing agreement. Prior to publication, findings from the project will be shared broadly at scientific meetings attended by ID researchers, especially those likely to be conducting clinical trials, such as meetings of the Down Syndrome Medical Interest Group, and International Down Syndrome Congress. In addition, the investigators will share information about the procedures freely with any investigators considering inclusion of cognitive outcome measures as a clinical endpoint.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Cognitive Outcomes in Down Syndrome-2
- ClinicalTrials.gov ID
- NCT04208685
- Acronym / sponsor ID
- ECODS-2 / 2018-0253
- Conditions
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 23 Dec 2019 (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.
As basic and behavioral science identify new ways to improve cognition and behavior in individuals with Down syndrome (DS), the lack of rigorous outcome measures represents an important problem for interpreting findings. Null findings in clinical trials could result from insensitive outcome measures, rather than ineffectiveness of treatment.
The long-term goal is to improve measurement of outcomes for children and adults with DS. Towards that goal, the investigators propose to test and refine a battery of cognitive measures that can be used in treatment studies focused on school-aged children and adults with Down syndrome. The batteries are designed to assess key domains of the DS phenotype where gaps remain in outcome measures, including attention, executive function, learning and memory, processing speed, and social cognition.
The investigators will examine the psychometric properties of measures (test-retest, validity, sensitivity to change), and to evaluate differences in the psychometric properties of measures as a function of variations in participant age, gender, degree of ID, and the participants' physical health and medical comorbidities. The investigators will evaluate at least 80 children and 50 adults with Down syndrome, per site, at five time points to evaluate key domains with a diverse and novel range of methods. This proposal aims to provide a preliminary evaluation to support the enhancement of clinical outcome measures, which ultimately will increase the accuracy in documenting improvements in the lives of children and young adults with Down syndrome.
Detailed description
The purpose of the proposed project is to test and refine a battery of cognitive measures that can be used in treatment studies focused on Down syndrome. The battery is designed to assess several key domains of the Down syndrome cognitive phenotype where gaps remain in outcome measures, including attention, executive function, learning and memory, processing speed, and social cognition, considering comorbid conditions that can potentially interfere with the development within these cognitive domains. Although a single battery for the entire lifespan of the individual with Down syndrome has obvious appeal, the investigators have focused their effort on the school-age years so that the investigators can capture a key time point in development of these cognitive domains. Moreover, new pharmaceutical treatments are transitioning from adults to the school-age population, making the need greatest for this portion of the lifespan.
However, based on preliminary research from the ongoing study with children, a need was identified to evaluate measures with young adults with DS (ages 18-39). Supplementary funding will support the expansion of the project to include young adults with DS. Results will provide empirical guidance for refining a battery and form the foundation for a larger-scale study evaluating outcome measures.
For participants 6-17 years, at least 160 children with Down syndrome will be recruited across two sites for the study, and participants will be enrolled over four (4) years. Following pre-screening and the consent visit to determine study eligibility, children will be assessed at 6 time points. The first assessment will be the baseline testing/Time 0 visit to assess IQ. At Time 1 baseline assessments for other functioning will be completed. A two-week interval will separate Time 1 and Time 2, at which time test-retest reliability assessments will be collected. Time 3 will occur three months following Time 2 to evaluate test sensitivity to change. Time 4 will occur 3 months following Time 3 and Time 5 will occur 6 months after Time 4 to assess longitudinal changes. The time interval was selected to replicate the duration of many clinical trials.
For participants 18-35 years, at least one hundred young adults aged 18-29 years with DS will be recruited across two sites to participate in the study. Adults will participate in neuropsychology assessments at 5 time points. Parents/Caregivers will complete behavioral measures at all time points. At Time 1 baseline assessments will be completed. A two-week interval (+/- 3 days) will separate Time 1 and Time 2, when test-retest reliability assessments will be collected. Time 3 will occur three months following Time 2 (+/- 2 weeks), Time 4 will occur three months following Time 3 (+/- 2 weeks), and Time 5 will occur 6 months following Time 4 (+/- 2 weeks) to evaluate sensitivity to change, Time 6 will occur 24 months following Time 1 (+/- 4 weeks), Time 7 will occur 36 months following Time 1 (+/- 4 weeks), and Time 8 will occur 48 months following Time 1 (+/- 4 weeks) to evaluate sensitivity to change. The three and six-month time intervals were selected to replicate the duration of many clinical trials. The 12-month interval was selected to provide a time interval in which natural development should occur and allow the investigators to evaluate sensitivity to change. In this study, change will occur due to natural development, while in a clinical trial, change would be expected due to treatment. The ability to detect relatively small developmentally-based change over 12 months will allow the investigators to evaluate if the measures could detect similarly small changes in trials. Once recruitment goals are met for NIH standards for 100 young adults, aged 18-29, the study team may begin recruiting adults who are 29-35, as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from clinics at Cincinnati Children's Hospital Medical Center (CCHMC), community physicians, and the Jane and Richard Thomas Center for Down Syndrome at CCHMC, as well as from the community physicians, clinics, and DS clinic at CSU. In addition, the Down Syndrome Association of Greater Cincinnati (DSAGC) and the Rocky Mountain Down Syndrome Association (RMDSA) will publicize our study through social media and their mailing lists that reaches over 12,000 families combined. Subjects may also be recruited from community programs such as baseball teams, Special Olympics, etc.
Key inclusion criteria (5 listed)
- 6-35 years old at the time of consent.
- Documented diagnosis of DS.
- Nonverbal mental age of at least 36 months to complete assessment battery (per parent/caregiver/young adult self-report).
- Willingness to maintain stables dosages of current medication or ongoing treatment for the duration of the study to limit changes while evaluating outcome measures.
- Parent/caregiver/self-report that participant will be able to complete the study, including all visits.
Key exclusion criteria (1 listed)
- History of blindness, deafness, or serious motor impairment
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
Psychometric properties of measures in the assessment battery, specifically establishing their test-retest reliability, validity, and sensitivity to change
Time frame: Through study completion, an average of 4 years
2 secondary outcomes
Psychometric properties of the measures as a function of variations in participant age, gender, and degree of ID
Time frame: Through study completion, an average of 4 years
Psychometric properties of the measures as a function of variations in the participants' physical health and medical comorbidities
Time frame: Through study completion, an average of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. The shared databases and corresponding dataset generated for statistical analysis will include demographic information, standardized, experimental and computerized assessment data, and information from parent- and teacher-rating scales. The dataset will include all composite variables and scores, with no identifying information included. The data and associated documentation will be available to users only under a data sharing agreement. Prior to publication, findings from the project will be shared broadly at scientific meetings attended by ID researchers, especially those likely to be conducting clinical trials, such as meetings of the Down Syndrome Medical Interest Group, and International Down Syndrome Congress. In addition, the investigators will share information about the procedures freely with any investigators considering inclusion of cognitive outcome measures as a clinical endpoint.
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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. This study is not recruiting at the moment.
Anna Esbensen, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
2 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, run by Children's Hospital Medical Center, Cincinnati at 2 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric properties of measures in the assessment battery, specifically establishing their test-retest reliability, validity, and sensitivity to change (time frame: Through study completion, an average of 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 12 Aug 2026.