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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02451657
Date of registration: 20/05/2015
Prospective Registration: Yes
Primary sponsor: Hoffmann-La Roche
Public title: Non-drug Study to Evaluate the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome
Scientific title: A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome
Date of first enrolment: June 2, 2015
Target sample size: 40
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02451657
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
France Spain United States
Contacts
Name:     Clinical Trials
Address: 
Telephone:
Email:
Affiliation:  Hoffmann-La Roche
Key inclusion & exclusion criteria

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.



Age minimum: 6 Years
Age maximum: 11 Years
Gender: All
Health Condition(s) or Problem(s) studied
Down Syndrome
Intervention(s)
Other: No Intervention
Primary Outcome(s)
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 6 months]
Secondary Outcome(s)
Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population [Time Frame: approximately 6 months]
Correlations between test results on functioning, adaptive behavior and cognition and IQ level [Time Frame: approximately 6 months]
Test/re-test reliability: Changes in test results over 6 months [Time Frame: approximately 6 months]
Secondary ID(s)
BP29589
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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