A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome

Completed

• Conditions: Down Syndrome

• Registration Number: NCT01580384
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests will be administered at clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between 24 and 27 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Males and females, 12 to 30 years of age, with diagnosis of Down Syndrome
• Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder can participate in the study provided they are on stable medication for at least 8 weeks prior to screening and likely to cooperate and take part successfully in the study assessments

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Exclusion Criteria

• Subjects with DSM-IV axis I and II psychiatric disorders, except those authorized in the inclusion criteria
• Subjects who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment
• Subjects with evidence of dementia or meeting clinical diagnosis for dementia
• Subjects with thyroid dysfunction or diabetes that is not adequately controlled and stabilized on treatment for at least 8 weeks prior to randomization

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurocognitive batteries/tests/scales: Suitability for individuals with Down syndrome assessed by number of tests completed/subjects completing, ceiling/floor effect, variance estimate of baseline/change from baseline	approximately 1.5 years

Secondary Outcome Measures

Name	Time	Method
Test/re-test reliability: Changes in test results over 4 weeks	approximately 1.5 years
Changes in test results over 6 month interval	approximately 1.5 years
Correlations between test results on functioning, adaptive behavior and cognition and IQ level	approximately 1.5 years