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Can new tests unlock hidden cognitive changes in down syndrome?

NCT ID NCT04208685

Knowledge-focused Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study is testing a set of cognitive assessments for children and adults with Down syndrome. The goal is to see if these tests are reliable, valid, and sensitive enough to detect changes in attention, memory, and other thinking skills. Participants aged 6 to 35 will complete the assessments at multiple visits. The findings could help design better future treatment trials for Down syndrome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to measure thinking and behavior changes in Down syndrome, helping future treatments show their true effects.
What could go wrong
This is an early-stage study focused on measurement tools, not a treatment. The tests may not prove sensitive enough to detect changes, and results may vary across different ages and abilities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

202 people

The number who actually took part.

Started

Jun 2018

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

6 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * History of blindness, deafness, or serious motor impairment

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Conditions

The condition(s) this trial relates to.

Down syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Down syndrome

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Colorado State University

    Fort Collins, Colorado, 80523, United States

More trials for these conditions

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