Background: Galantamine, a novel drug for Alzheimer’s disease (AD), offers specific nicotinic receptor stimulating properties that may contribute to the distinct effects seen in all tested domains. There is increasing interest to support the patients across the whole AD spectrum with highly effective drugs and to prove treatment benefits also in advanced moderate stages of the disease. Galantamine has consistently shown significant superiority over placebo in a large international clinical trial program on more than 3200 patients with mild-to-moderate AD.
Objective: A post-hoc analysis was performed to investigate the efficacy of galantamine 24mg/day on the advanced-moderate edge of all treated patients.
Design: Based on similar trial designs we pooled the data on galantamine 24mg/day out of 4 randomized placebo-controlled trials over 3-6 months with two open-label follow-up trials for up to 1 year and compared them with matched controls from a 12-month historical placebo group.
Materials and Methods: The selected “advanced moderate” subgroups comprised patients with ADAS-cog >30 and MMSE £14 at baseline. The cognitive performance was assessed with the ADAS-cog scale over 12 months and the DAD scores were measured to evaluate functional disabilities.
Results: Patients with advanced-moderate AD who received galantamine 24mg/day over 12 months had maintained their cognitive function at baseline levels and performed significantly superior to placebo (p<0.001). 51% of all patients with ADAS-cog >30 were maintained or improved above baseline versus only 13% in the placebo-group (p<0.001). In the subgroup of patients with MMSE £14 the results were likewise significant with 48% galantamine treated patients and only 4% patients in the placebo group that had stabilized or improved their baseline ADAS-cog scores after 12 months (p<0.001). Both evaluations showed a substantial treatment difference of around 10 points between galantamine and placebo/untreated subjects. DAD scores on functional abilities were only assessed from the subgroup of patients with baseline ADAS-cog >30, as for MMSE £14 the reported small sample did not allow a conclusion. Galantamine-treated patients with ADAS-cog>30 performed significantly better on their DAD scores versus placebo (p<0.001), i.e. patients from the historical placebo group had dropped by more than 20 points below baseline after 12 months compared to a minor decline of 6.3 points in patients receiving galantamine. Stabilization or improvements on the DAD scale (³0 points) were seen in 39% of all galantamine patients versus 12% in the historical placebo group.
Conclusion: The benefits of galantamine treatment are maintained for at least 12 months also in patients with advanced-moderate AD. The cognitive levels are maintained at baseline levels and the functional abilities were significantly improved in patients receiving galantamine. The extent of efficacy in the advanced-moderate subset of AD patients is at least as great as observed in the mild-to-moderate population.
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