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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01580384
First received: March 23, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This non-drug, longitudinal, multi-center, multi-national study will evaluate th e suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests w ill 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
Down Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Test/re-test reliability: Changes in test results over 4 weeks [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Changes in test results over 6 month interval [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Correlations between test results on functioning, adaptive behavior and cognition and IQ level [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals with Down Syndrome

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580384

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01580384     History of Changes
Other Study ID Numbers: BP25612
Study First Received: March 23, 2012
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Down Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 24, 2014