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

Completed

• Conditions: Down Syndrome
• Interventions: Other: No Intervention

• Registration Number: NCT02451657
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-22
• Study Start: 2015-06-02
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	No Intervention	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Hospital Infantil Universitario Niño Jesus; Pediatria Social; 🇪🇸 Madrid, Spain

University of Arizona; 🇺🇸 Tucson, Arizona, United States

IMIM, Human Pharmacology and Clinical Neurosciences,; 🇪🇸 Barcelona, Spain

CHU de Saint Etienne; Service de Génétique; 🇫🇷 St Etienne, France

Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría; 🇪🇸 Santiago de Compostela, La Coruña, Spain

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Duke Clin Rsch Institute; 🇺🇸 Durham, North Carolina, United States

Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon; 🇫🇷 Bron, France

CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale; 🇫🇷 Bordeaux, France

CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique; 🇫🇷 Montpellier, France