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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

NCT ID: NCT02451657

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-02

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Down Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No Intervention

Intervention Type OTHER

No intervention was administered in this study

Interventions

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No Intervention

No intervention was administered in this study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Duke Clin Rsch Institute

Durham, North Carolina, United States

Site Status

CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale

Bordeaux, , France

Site Status

Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

Bron, , France

Site Status

CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

Montpellier, , France

Site Status

CHU de Saint Etienne; Service de Génétique

Saint-Etienne, , France

Site Status

Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

Santiago de Compostela, La Coruña, Spain

Site Status

IMIM, Human Pharmacology and Clinical Neurosciences,

Barcelona, , Spain

Site Status

Hospital Infantil Universitario Niño Jesus; Pediatria Social

Madrid, , Spain

Site Status

Countries

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United States France Spain

Other Identifiers

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BP29589

Identifier Type: -

Identifier Source: org_study_id