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This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| AQW051 Dose 1 | Experimental |
| |
| AQW051 Dose 2 | Experimental |
| |
| AQW051 Dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (single and multiple doses) | Drug |
| ||
| AQW051 2 mg (single and multiple doses) |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests | 132 days Part A, 121 days Part B (screening to study completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests | 132 days Part A, 121 days Part B (screening to study completion) | |
| Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140, | Glendale | California | 91206 | United States | ||
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| Label | URL |
|---|---|
| Results for CAQW051A2205 from the Novartis Clinical Trials website | View source |
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| Drug |
|
| AQW051 15mg (single and multiple doses) | Drug |
|
| AQW051 100mg (single dose), and 50mg (multiple doses) | Drug |
|
| 132 days Part A, 121 days Part B (screening to study completion) |
| Correlation of the cognitive domains measured by MCCB versus CogState | 132 days Part A, 121 days Part B (screening to study completion) |
| Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo | 132 days Part A, 121 days Part B (screening to study completion) |
| CRI Worldwide, 1113 Hospital Dr. Suite 202, |
| Willingboro |
| New Jersey |
| 08046 |
| United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D006212 | Hallucinations |
| D001523 | Mental Disorders |
| D003702 | Delusions |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| C000602881 | 3-(6-p-tolylpyridin-3-yloxy)-1-azabicyclo(2.2.2)octane |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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