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

Down Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580384
• Other study ID #: BP25612
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: March 2, 2015
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Down Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Test/re-test reliability: Changes in test results over 4 weeks		approximately 1.5 years	No
Secondary	Changes in test results over 6 month interval		approximately 1.5 years	No
Secondary	Correlations between test results on functioning, adaptive behavior and cognition and IQ level		approximately 1.5 years	No