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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580384
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease
Down Syndrome

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with Down Syndrome

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01580384

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United States, Arizona
Tucson, Arizona, United States, 85721
United States, North Carolina
Durham, North Carolina, United States, 27710
Ciudad Autonoma de Bs As, Argentina, 1426
Ciudad de Buenos Aires, Argentina, C1405BOA
Canada, Nova Scotia
Kentville, Nova Scotia, Canada, B4N 4K9
Paris, France, 75015
St Etienne, France, 42055
Roma, Lazio, Italy, 00165
Palermo, Sicilia, Italy, 90127
Barcelona, Spain, 08009
United Kingdom
London, United Kingdom, W1W 7EJ
Redruth, United Kingdom, TR15 2SP
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT01580384    
Other Study ID Numbers: BP25612
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Down Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn