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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No intervention was administered in this study |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724-5030 | United States | ||
| Massachusetts General Hospital |
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| Correlations between test results on functioning, adaptive behavior and cognition and IQ level | approximately 6 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Duke Clin Rsch Institute | Durham | North Carolina | 27710 | United States |
| CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale | Bordeaux | 33076 | France |
| Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon | Bron | 69003 | France |
| CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique | Montpellier | 34295 | France |
| CHU de Saint Etienne; Service de Génétique | Saint-Etienne | 42055 | France |
| Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría | Santiago de Compostela | La Coruña | 15706 | Spain |
| IMIM, Human Pharmacology and Clinical Neurosciences, | Barcelona | 08009 | Spain |
| Hospital Infantil Universitario Niño Jesus; Pediatria Social | Madrid | 28009 | Spain |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
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