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NCT Number: NCT01580384

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ciudad Autonoma de Bs As, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Test/re-test reliability: Changes in test results over 4 weeks

    Time frame: approximately 1.5 years

  2. Changes in test results over 6 month interval

    Time frame: approximately 1.5 years

  3. Correlations between test results on functioning, adaptive behavior and cognition and IQ level

    Time frame: approximately 1.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2012
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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