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To evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in view of their use in future multicenter, multinational clinical efficacy trials testing a putative cognitive enhancer for individuals with Down syndrome aged 6-30.
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| Measure | Description | Time Frame |
|---|---|---|
| Suitability for individuals with Down syndrome assessed by number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values. | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Individuals 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.
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People with Down syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Hideaki Takahashi | Chugai Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan | ||||
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Yokohama |
| Kanagawa |
| Japan |
| Izumi | Osaka | Japan |
| Takatsuki | Osaka | Japan |
| Saitama | Saitama | Japan |
| Chiyoda-ku | Tokyo | Japan |
| Setagaya-ku | Tokyo | Japan |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |