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 |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 12 - 30 |
| Updated: | 7/16/2013 |
| Start Date: | February 2012 |
| End Date: | February 2014 |
| Contact: | Reference Study ID Number: BP25612 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global.rochegenentechtrials@roche.com |
| Phone: | 888-662-6728 (U.S. Only) |
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.
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
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