| Abstract: | SUMMARY Background: Galantamine is an acetylcholinesterase inhibitor that modulates nicotinic receptors. It is effective in mild to moderate Alzheimer’s disease (AD) but no trial has focused exclusively on mild AD. We performed a post-hoc sub-set analysis using data from four randomised trials to explore the efficacy of galantamine versus placebo in mild AD.Methods: Participants in all studies met NINCDS-ADRDA criteria for probable AD. We examined data from patients with baseline Mini Mental State Examination (MMSE) 21–24 who received galantamine 24 mg/day (GAL) or placebo (PLAC). Scores for the Alzheimer’s Disease Assessment Scale-cognitive subset (ADAS–cog), Clinician’s Interview–Based Impression of Change (CIBIC), Disability Assessment for Dementia (DAD), and ACDS-ADL scales were compared.Results:Of the 694 patients (362 GAL, 332 PLAC, mean baseline MMSE 22.4 ± 1.1, mean age 74 ± 7.9 years), 65% completed 6 months treatment (223 GAL, 229 PLAC). Mean change in ADAS-cog at 6 months was –1.5 (95% confidence interval –2.2, –0.8, p < 0.001) for GAL and + 0.2 (–0.6, 0.9, p = 0.72) for PLAC. This difference was statistically significant ( p = 0.001).Significantly more patients receiving galantamine were classified as ‘improved’ using the CIBIC (26.9% GAL vs 14.3% PLAC, p < 0.001). Galantamine was generally well tolerated; most common adverse events were nausea, vomiting and diarrhoea.Conclusion: Pooled data from four randomised trials of patients with mild AD indicate that patients who received galantamine 24 mg/day for 6 months improved cognition more often than those who received placebo and that a higher proportion receiving galantamine were globally improved. This suggests that patients with mild AD benefit from galantamine treatment. |
