Down Syndrome
Conditions
Brief summary
The aim of this study is to assess the suitability of selected scales (floor/ceiling effects, variability, test-retest reliability) to measure cognitive function in children with Down syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or language on these neurocognitive scales.
Interventions
OTHERNo Intervention
No intervention was administered in this study
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 6 to 11 with diagnosis of Down syndrome (Trisomy 21). Children may have standard trisomy 21, Robertsonian translocation, isochromosome 21 (so called 21q21q Robertsonian translocation), Down syndrome with reciprocal translocation or mosaicism. * Down syndrome children meeting clinical diagnostic criteria for generalized anxiety disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate in the study provided they are considered clinically stable or on stable medication for at least 8 weeks prior to the baseline visit. * Parent or legal guardian/representative and caregiver willing to give written informed consent. * Subjects with sufficient vision and hearing to engage in study evaluations as referred by their parents. Mild hearing loss will be allowed.
Exclusion criteria
* Children who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators * Significant sleep disruption or moderate to severe untreated obstructive sleep apnea. * Any condition which would make the individual or the caregiver, in the opinion of the investigator, unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Test/re-test reliability: Changes in test results over 6 months | approximately 6 months |
| Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population | approximately 6 months |
| Correlations between test results on functioning, adaptive behavior and cognition and IQ level | approximately 6 months |
Countries
France, Spain, United States
Outcome results
None listed