The Galantamine USA-10 Study Group investigated the efficacy and tolerability of galantamine, using a slow dose escalation schedule of up to 8 weeks, in 978 patients with mild to moderate AD. Following a 4-week placebo run-in, patients were randomized to one of four treatment arms: placebo or galantamine escalated to final maintenance doses of 8, 16, or 24mg/day. Outcome measures included the ADAS-Cog, the CIBIC-plus, the AD Cooperative Study Activities of Daily Living inventory, and the Neuropsychiatric Inventory (NPI). After 5 months, the galantamine-placebo differences on ADAS-Cog were 3.3 points for the 16 mg/day group and 3.6 points for the 24 mg/day group (p < 0.001 versus placebo, both doses).

In this study, 35.6% of patients receiving 16 mg/day and 37.0% of patients receiving 24 mg/day showed improvements of 4 points on the ADAS-cog, compared with only 19.6% of placebo-treated patients.