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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

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ClinicalTrials.gov Identifier: NCT01580384
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date March 23, 2012
First Posted Date April 19, 2012
Last Update Posted Date March 3, 2015
Study Start Date February 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2012)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01580384 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 18, 2012)
  • Test/re-test reliability: Changes in test results over 4 weeks [ Time Frame: approximately 1.5 years ]
  • Changes in test results over 6 month interval [ Time Frame: approximately 1.5 years ]
  • Correlations between test results on functioning, adaptive behavior and cognition and IQ level [ Time Frame: approximately 1.5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals with Down Syndrome
Condition Down Syndrome
Intervention Not Provided
Study Groups/Cohorts Cohort
Publications * Spiridigliozzi GA, Goeldner C, Edgin J, Hart SJ, Noeldeke J, Squassante L, Visootsak J, Heller JH, Khwaja O, Kishnani PS, Liogier d'Ardhuy X. Adaptive behavior in adolescents and adults with Down syndrome: Results from a 6-month longitudinal study. Am J Med Genet A. 2019 Jan;179(1):85-93. doi: 10.1002/ajmg.a.60685. Epub 2018 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 18, 2012)
90
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Canada,   France,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries Korea, Republic of
 
Administrative Information
NCT Number NCT01580384
Other Study ID Numbers BP25612
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2015