Long‐term efficacy and safety of galantamine in patients with mild‐to‐moderate Alzheimer's disease: multicenter trial

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Abstract
In clinical trials, short‐term galantamine treatment produces consistent positive effects on global ratings, cognitive tests, and assessments of activities of daily living and behavior in patients with mild‐to‐moderate Alzheimer's disease (AD), providing the rationale for longer‐term, open‐label treatment. In this continuation trial following enrollment in previous 12‐month trials, patients received galantamine 24 mg/day for a total of 24 months (total exposure up to 36 months). Primary efficacy measures were the ADAS‐cog/11 and DAD. Adverse events (AEs) were coded to WHO preferred terms, including AEs begun in previous trials. Initial improvement in cognitive function was followed by a gradual decline, as measured by increased ADAS‐cog/11 scores. At 36 months, ADAS‐cog/11 scores increased by a mean (SEM) of 12.4 (0.80) points (P < 0.001) versus a projected 22‐point increase for untreated patients. Functional abilities, as measured by the DAD, had decreased significantly at each time point versus baseline (P < 0.001). The most common treatment‐emergent AEs were agitation (16.1%), insomnia (12.4%), fall (11.2%), and urinary tract infection (10.2%). AEs were mainly mild to moderate, appropriate for an elderly population, with few judged treatment related. Galantamine 24 mg/day is safe and effective for long‐term treatment of mild‐to‐moderate AD. Potential exists for prolonged benefit with galantamine therapy versus lack of treatment for the long‐term.