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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01580384

Enrollment

Registered

2012-04-19

Start date

2012-02-29

Completion date

2014-01-31

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 30 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Argentina, Canada, France, Italy, Spain, United Kingdom, United States

Outcome results