Clinical trial NCT02451657: 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.

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.


Eligibility 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.

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 6 months
Secondary outcomes:
measure: Test/re-test reliability: Changes in test results over 6 months
timeFrame: approximately 6 months
measure: Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population
timeFrame: approximately 6 months
measure: Correlations between test results on functioning, adaptive behavior and cognition and IQ level
timeFrame: approximately 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke Clin Rsch Institute
state: North Carolina
city: Bordeaux
country: France
facility: CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale
city: Bron
country: France
facility: Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon
city: Montpellier
country: France
facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
city: St Etienne
country: France
facility: CHU de Saint Etienne; Service de Génétique
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
state: La Coruña
city: Barcelona
country: Spain
facility: IMIM, Human Pharmacology and Clinical Neurosciences,
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesus; Pediatria Social
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: