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Trial record 27 of 184 for:    trisomy21 NOT prenatal

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02451657
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Down Syndrome Other: No Intervention

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 2, 2015
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

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

Primary Outcome Measures :
  1. 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 [ Time Frame: approximately 6 months ]

Secondary Outcome Measures :
  1. Test/re-test reliability: Changes in test results over 6 months [ Time Frame: approximately 6 months ]
  2. Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population [ Time Frame: approximately 6 months ]
  3. Correlations between test results on functioning, adaptive behavior and cognition and IQ level [ Time Frame: approximately 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02451657

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

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Responsible Party: Hoffmann-La Roche Identifier: NCT02451657    
Other Study ID Numbers: BP29589
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Down Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn