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This multi-center, randomized double-blind, placebo-controlled study will assess the safety and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be randomized in cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated time on study treatment is 38 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | multiple oral doses |
| |
| RG1662 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests | 5-6 weeks | |
| Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC) | 5-6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85013 | United States | |||
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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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| Drug |
Cohorts receiving multiple oral doses |
|
| Little Rock |
| Arkansas |
| 72204 |
| United States |
| La Jolla | California | 92037 | United States |
| Aurora | Colorado | 80045 | United States |
| Decatur | Georgia | 30033 | United States |
| Chicago | Illinois | 60612 | United States |
| Baltimore | Maryland | 21287 | United States |
| Durham | North Carolina | 27710 | United States |
| London | NW10 7EW | United Kingdom |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |