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Also known as galantamine ER
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 to treat Alzheimer disease and vascular dementia. It is a small molecule developed by Johnson & Johnson (ticker JNJ) and studied in Phase 3 clinical trials. The research program enrolled 1,441 participants across six completed trials, all randomized, double-blind, and placebo-controlled.
Galantamine targets acetylcholinesterase (ACHE) and acts as an inhibitor of that enzyme. This target class places galantamine among the cholinesterase inhibitors studied in neurology for Alzheimer disease and vascular dementia. The clinical program was conducted by Johnson & Johnson under ticker JNJ.
Galantamine is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 3 clinical program evaluating galantamine in Alzheimer disease and vascular dementia, including efficacy, cardiac safety, and long-term safety studies.
Galantamine has been studied in Phase 3 clinical development. Six trials are recorded, all completed, with no active trials currently listed. The program enrolled 1,441 participants and used randomized, double-blind, placebo-controlled designs across the Alzheimer disease and vascular dementia studies.
Galantamine has been evaluated in completed Phase 3 trials including NCT00814801, an efficacy and safety study in Alzheimer's disease conducted in Japan with 580 participants; NCT00309725, a cardiac safety study with 139 participants; NCT00304629, a long-term safety and efficacy study with 241 participants; and NCT00301574, an efficacy and safety study with 398 participants.
Galantamine ER and Galantamine 16 mg/day are alternative names used for galantamine. Searches for galantamine ER or galantamine 16 mg/day refer to the same small molecule developed by Johnson & Johnson (ticker JNJ) and studied in Phase 3 trials for Alzheimer disease and vascular dementia.