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 studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT01580384

Run by

Hoffmann-La Roche

People needed

90

Starts

2012-02-01

Expected to finish

2014-01-01

Last updated by the study team

2015-03-03

Who can join

Age: 12 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Durham, North Carolina, United States
• Study site — Ciudad Autonoma de Bs As, Argentina
• Study site — Ciudad de Buenos Aires, Argentina
• Study site — Kentville, Nova Scotia, Canada
• Study site — Paris, France
• Study site — Saint-Etienne, France
• Study site — Rome, Lazio, Italy
• Study site — Palermo, Sicily, Italy
• Study site — Barcelona, Barcelona, Spain
• Study site — London, United Kingdom
• Study site — Redruth, United Kingdom

Full record on ClinicalTrials.gov

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