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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/VI-1121 | Experimental | Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period. |
|
| VI-1121/Placebo | Experimental | Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VI-1121 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period. | 12 weeks | |
| Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | 94109 | United States | |||
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 12 Weeks |
| Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period | 12 Weeks |
| Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to Weeks 4, 8, and 12 of each treatment period | 4, 8, and 12 Weeks |
| Santa Monica |
| California |
| 90404 |
| United States |
| Sunrise | Florida | 33351 | United States |
| Louisville | Kentucky | 40217 | United States |
| Las Vegas | Nevada | 89113 | United States |
| Toms River | New Jersey | 08755 | United States |
| New Windsor | New York | 12553 | United States |
| Durham | North Carolina | 27710 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Toledo | Ohio | 43623 | United States |
| Plano | Texas | 75075 | United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |