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
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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.
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 [ Time Frame: approximately 1.5 years ]
Secondary Outcome Measures :
Test/re-test reliability: Changes in test results over 4 weeks [ Time Frame: approximately 1.5 years ]
Changes in test results over 6 month interval [ Time Frame: approximately 1.5 years ]
Correlations between test results on functioning, adaptive behavior and cognition and IQ level [ Time Frame: approximately 1.5 years ]
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Ages Eligible for Study:
12 Years to 30 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Individuals with Down Syndrome
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
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