Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial

Objective To evaluate the efficacy and safety of galantamine in the treatme nt of Alzheimer's disease. Design Randomised, double blind, parallel group, placebo controlled trial. Setting 86 outpatient clinics in Europe and Canada. Participants 653 patients with mild to moderate Alzheimer's disease. Intervention Patients randomly assigned to galantamine had their daily dose escalated over three to four weeks to maintenance doses of 24 or 32 mg. Main outcome measures Scores on the 11 item cognitive subscale of the Alzhe imer's disease assessment scale, the clinician's interview based impression of change plus caregiver input, and the disability assessment for dementia scale. The effect of apolipoprotein E4 genotype on response to treatment w as also assessed. Results At six months, patients who received galantamine had a significantl y better outcome on the 11 item cognitive subscale of the Alzheimer's disea se assessment scale than patients in the placebo group (mean treatment effe ct 2.9 points for lower dose and 3.1 for higher dose, intention to tr eat a nalysis, P < 0.001 for both doses). Galantamine was more effective than pla cebo on the clinician's interview based impression of change plus caregiver input (P < 0.05 for both doses v placebo). At six months, patients in the higher dose galantamine group had significantly better scores on the disabi lity assessment for dementia scale than patients in the placebo group (mean treatment effect 3.4 points, P < 0.05). Apolipoprotein E genotype had no e ffect on the efficacy of galantamine. 80% (525) of patients completed the s tudy. Conclusion Galantamine is effective and well tolerated in Alzheimer's disea se. As galantamine slowed the decline of functional ability as well as cogn ition, its effects are likely to be clinically relevant.