Objective: To report the long-term safety and efficacy of galantamine in patients with Alzheimer's disease with cerebrovascular disease (AD + CVD) or probable vascular dementia (VaD).
Design: In a double-blind, multicenter trial, 537 patients diagnosed with AD + CVD or VaD were randomized to receive galantamine 24 mg/day (n = 359) or placebo (n = 178) for 6 months. All patients were eligible to enter a 6-month, galantamine-only, open-label extension (OLE). All patients who completed the 12-month study (n = 326) were eligible to enter an additional 24-month OLE. This analysis was performed at Month 12 of the 24-month OLE study (total treatment duration: 24 months).
Materials and methods: Changes in cognitive ability over time were assessed using the 11-item Alzheimer's Disease Assessment Scale–cognitive subscale (ADAS-cog/11). Changes were calculated relative to the original baseline of the double-blind phase (baseline) and to the initial visit of the current study (Month 12). Safety was assessed through reporting of adverse events and by changes in electrocardiogram (ECG) recordings, vital signs, and laboratory parameters.
Results: Of the 326 patients randomized to receive treatment, 248 (76.1%) completed 12 months of the trial. A 12-month interim investigation of the 2-year OLE indicated that patients who received galantamine for the entire study demonstrated the least cognitive decline (2.7 points on the ADAS-cog/11). The long-term benefits of galantamine were evident in both groups. In patients with VaD, cognition was maintained above baseline levels for approximately 21 months and was not significantly different from baseline at 24 months. In patients with AD + CVD, cognition was maintained above baseline levels for 12 months. The most frequently reported adverse events, characteristic of older patients with dementia, included depression (13%), agitation (12%), and insomnia (11%). Gastrointestinal adverse events were less common than in the initial 12-month study, indicating a decline in incidence with long-term therapy.
Conclusions: Long-term galantamine therapy (up to 24 months) in patients with VaD or AD + CVD is well tolerated and associated with prolonged maintenance of cognitive function. This is the first study demonstrating clinically relevant long-term cognitive benefits in a population of patients with limited therapeutic options. The significant efficacy observed here may reflect the unique dual mode of action of galantamine.
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