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NCT04208685 · ClinicalTrials.gov registry record
Evaluating Cognitive Outcomes in Down Syndrome
A clinical trial of Down Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- 202
- Enrollment target
- 2
- Study locations
NCT04208685 is a study of Down Syndrome that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 202 participants, below the 2,468-participant average among 54 other Down Syndrome trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04208685, a study of Down Syndrome, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- 202 participants
- Enrollment target
- 2
- Study locations
Study 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. 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.
Conditions Studied
Study Locations (2)
Colorado
- Colorado State University - Fort Collins
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2026-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04208685
The ClinicalTrials.gov registry entry for NCT04208685 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,468-participant average among 54 other Down Syndrome trials with a reported enrollment target (92% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT04208685 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT04208685 about?
NCT04208685 is a clinical study titled "Evaluating Cognitive Outcomes in Down Syndrome". 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...
What is the current status of trial NCT04208685?
This trial is currently active not recruiting. The enrollment target is 202 participants. The study started on 2018-06-18. Estimated completion is 2026-06.
What conditions does trial NCT04208685 study?
This clinical trial studies the following conditions: Down Syndrome.
Who is sponsoring clinical trial NCT04208685?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04208685 being conducted?
This trial has 2 study locations across Colorado, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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