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galantamine · 7 trials · 3 indications
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...
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Galantamine is used for the treatment of Alzheimer's disease, including Alzheimer's disease with dementia and vascular dementia. It is being studied in Phase 3 clinical trials for these neurological conditions.
Galantamine is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.
Galantamine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities based on the available information. All completed trials are Phase 3 studies.
Galantamine has completed four Phase 3 trials, including NCT00082602, NCT00304629, NCT00309725, and NCT00814801. These studies evaluated safety, tolerability, long-term efficacy, and cardiac safety in patients with Alzheimer's disease.
Galantamine is also known by the brand name Razadyne. It is a small molecule being studied for Alzheimer's disease and related dementias.