Objective: To compare the long-term safety and efficacy of galantamine 24 mg/day and donepezil 10 mg/day in patients with Alzheimer's disease (AD).
Design: In a multicenter trial, patients diagnosed with AD (NINCDS-ADRDA criteria) received either galantamine 16 mg/day (n = 94) or donepezil 5 mg/day (n = 88) for 52 weeks in a rater-blinded, randomized, parallel-group study. Galantamine was escalated to 16 mg/day (consistent with current dosing recommendations), with investigators given the option to increase the dose to 24 mg/day at Week 13. Donepezil could be increased to 10 mg/day after 4 weeks.
Materials and methods: The primary objective of this exploratory study was to compare the effects of galantamine and donepezil on functional abilities as measured by the Bristol Activities of Daily Living Scale (BrADL), with additional comparisons of effects on cognition. The Mini-Mental State Examination (MMSE) and the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog/11) were used to evaluate changes in cognitive function. Safety and adverse events also were monitored.
Results: At study end, 80.4% of galantamine and 78.0% of donepezil patients remained on therapy. At Week 52, similar percentages of patients in each group demonstrated a positive response on the BrADL (GAL 39.3% vs DON 39.0%, p = 0.9679). More galantamine-treated patients had a favorable response on the ADAS-cog (GAL 44.9%, DON 31.7%, p = 0.0766) and MMSE (GAL 55.2%, DON 32.5%, p = 0.0036) at Week 52. Similar results were observed among patients with moderate AD (MMSE 12–18) as measured by the MMSE (GAL 57.9%, DON 29.9%, p = 0.008) and ADAS-cog (GAL 48.1%, DON 30.0%, p = 0.0258). Both treatments were well tolerated during this study. Most adverse events were transient and of mild-to-moderate intensity, and were consistent with the findings of previous clinical trials.
Conclusions: Significant advantages were found in the treatment response to galantamine (compared with donepezil) on cognition as measured by response to the MMSE and ADAS-cog/11. Thus, galantamine deserves first-line consideration in the treatment of patients with AD.
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