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

Down Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451657
• Other study ID #: BP29589
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: October 24, 2017
• Start date: June 2, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: October 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Other:
• No Intervention
No intervention was administered in this study

Locations

Country	Name	City	State
France	CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale	Bordeaux
France	Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon	Bron
France	CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique	Montpellier
France	CHU de Saint Etienne; Service de Génétique	St Etienne
Spain	IMIM, Human Pharmacology and Clinical Neurosciences,	Barcelona
Spain	Hospital Infantil Universitario Niño Jesus; Pediatria Social	Madrid
Spain	Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría	Santiago de Compostela	La Coruña
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke Clin Rsch Institute	Durham	North Carolina
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Test/re-test reliability: Changes in test results over 6 months		approximately 6 months
Secondary	Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population		approximately 6 months
Secondary	Correlations between test results on functioning, adaptive behavior and cognition and IQ level		approximately 6 months