This study is currently recruiting participants.
Number
000942-M
Sponsoring Institute
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 4 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Non-English Speaking
Keywords
Intellectual Disabilities; Cognitive Test Battery; Assesment; Cognition; Outcome Measure; Natural History
Recruitment Keyword(s)
None
Condition(s)
intellectual disabilities; Fragile X; Down Syndrome
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Mental Health
People with intellectual disability (ID) may be limited in how they can think and behave. These limits affect their social and practical skills. Recent studies with animals have led to trials with drugs that may help to change both brain function and behavior in people with ID. But researchers need a reliable way to test how people in these trials respond to treatment.
Objective:
This natural history study will explore how effectively 1 test can track intellectual changes among people with ID. This test is called the NIH-TCB (National Institutes of Health Toolbox Cognitive Battery).
Eligibility:
People aged 4 years or older with ID. People older than 25 years must have a mental age >3 years.
Design:
All participants will have at least 1 visit to the clinic. This visit will last 6 to 7 hours.
Participants will take several tests to measure their thinking skills. The NIH-TCB test uses an iPad to measure skills like memory, attention, and reading.
The participant s parent or caregiver will complete a questionnaire. They will answer questions about the participant s background and development. Other topics will include how the participant communicates and relates to other people. The parent will talk about their relationship with their child for 5 minutes; this interview will be audio recorded.
Some participants may have a second visit 4 weeks later. This visit will last less than 2 hours. They will repeat the iPad-based test from their first visit.
Participants younger than 25 years may return for another visit 2 years later. They will take all of the same tests again. Their parent or caregiver will also repeat the questionnaire.
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Individuals will be pre-screened for eligibility with a parent, caregiver, or legally authorized representative. Pre-screening will occur either via telephone communication or in person when family members visit the MIND Institute and express interest in research study participation. Additional eligibility screening will be performed during the initial study visit. INCLUSION CRITERIA: 1. Developmental Arm: Males or females who are (or were if enrolled in phase 1) between the ages of 4 and 25 years at enrollment with a diagnosis of intellectual disability associated with fragile X syndrome, Down syndrome, Williams syndrome, or from other or undetermined causes. 2. Aging Arm: Males or females who are > 25 years at enrollment with Down syndrome (including those with dementia) or fragile X syndrome with a mental age > 3.0 years as measured by the Stanford Binet-5th edition. 3. A full scale IQ below 80 as measured by the Stanford Binet-5th edition. 4. English Speaking. EXCLUSION CRITERIA: 1. Mental age under 1 year, 0 months as determined by the Stanford Binet-5th edition. 2. Uncorrectable vision impairment. 3. Significant motor impairment preventing touch screen or keypad responses. 4. History of head injury, brain infection, stroke or other neurological problems such as uncontrolled daily seizures or excessive sedation from medication. 5. Any changes to medication 6 weeks prior to study enrollment.
INCLUSION CRITERIA:
1. Developmental Arm: Males or females who are (or were if enrolled in phase 1) between the ages of 4 and 25 years at enrollment with a diagnosis of intellectual disability associated with fragile X syndrome, Down syndrome, Williams syndrome, or from other or undetermined causes.
2. Aging Arm: Males or females who are > 25 years at enrollment with Down syndrome (including those with dementia) or fragile X syndrome with a mental age > 3.0 years as measured by the Stanford Binet-5th edition.
3. A full scale IQ below 80 as measured by the Stanford Binet-5th edition.
4. English Speaking.
EXCLUSION CRITERIA:
1. Mental age under 1 year, 0 months as determined by the Stanford Binet-5th edition.
2. Uncorrectable vision impairment.
3. Significant motor impairment preventing touch screen or keypad responses.
4. History of head injury, brain infection, stroke or other neurological problems such as uncontrolled daily seizures or excessive sedation from medication.
5. Any changes to medication 6 weeks prior to study enrollment.
Principal Investigator
Referral Contact
For more information: