Clinical trial 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with Down Syndrome

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.


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

Primary outcomes:
measure: 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
timeFrame: approximately 1.5 years
Secondary outcomes:
measure: Test/re-test reliability: Changes in test results over 4 weeks
timeFrame: approximately 1.5 years
measure: Changes in test results over 6 month interval
timeFrame: approximately 1.5 years
measure: Correlations between test results on functioning, adaptive behavior and cognition and IQ level
timeFrame: approximately 1.5 years
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Durham
country: United States
state: North Carolina
city: Ciudad Autonoma de Bs As
country: Argentina
city: Ciudad de Buenos Aires
country: Argentina
city: Kentville
country: Canada
state: Nova Scotia
city: Paris
country: France
city: St Etienne
country: France
city: Roma
country: Italy
state: Lazio
city: Palermo
country: Italy
state: Sicilia
city: Barcelona
country: Spain
city: London
country: United Kingdom
city: Redruth
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.