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 studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT02451657

Run by

Hoffmann-La Roche

People needed

40

Starts

2015-06-02

Expected to finish

2016-06-30

Last updated by the study team

2017-10-25

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Duke Clin Rsch Institute — Durham, North Carolina, United States
• 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 — Saint-Etienne, France
• Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría — Santiago de Compostela, La Coruña, Spain
• IMIM, Human Pharmacology and Clinical Neurosciences, — Barcelona, Spain
• Hospital Infantil Universitario Niño Jesus; Pediatria Social — Madrid, Spain

Full record on ClinicalTrials.gov

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