Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00814801 | An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease | PHASE3 | COMPLETED | 580 | — | — | Feb 1, 2007 | Sep 1, 2008 | Apr 17, 2014 | 1 | Japan |
| NCT00082602 | Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease | PHASE3 | COMPLETED | 83 | — | — | May 1, 2004 | Apr 1, 2005 | May 20, 2011 | - | — |
| NCT00309725 | A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease. | PHASE3 | COMPLETED | 139 | — | — | - | Oct 1, 1999 | May 18, 2011 | - | — |
ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment.
CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from "markedly improved" to "markedly worse".
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Galantamine 16 mg/day | EXPERIMENTAL | - |
| Galantamine 24 mg/day | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks. |
| Galantamine 16 mg/day | DRUG | Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks. |
| Galantamine 24 mg/day | DRUG | Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks. |
| galantamine ER | DRUG | - |
| galantamine | DRUG | - |
Inclusion Criteria: * Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria * Having a Mini-Mental Status Examination (MMSE) score of 1...