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

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

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale
  • Bron, France, 69003
    • Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon
  • Montpellier, France, 34295
    • CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
  • St Etienne, France, 42055
    • CHU de Saint Etienne; Service de Génétique
• Spain
  • Barcelona, Spain, 08009
    • IMIM, Human Pharmacology and Clinical Neurosciences,
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Niño Jesus; Pediatria Social
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724-5030
      • University of Arizona
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Clin Rsch Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort	Other: No Intervention; No intervention was administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2015
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: BP29589