Galantamine: a randomized, double‐blind, dose comparison in patients with Alzheimer's disease

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Abstract
Objectives: To investigate whether Galantamine significantly improves the core symptoms of Alzheimer's disease (AD).Background: Galantamine is a reversible, competitive, selective inhibitor of acetylcholinesterase (AChE) that also allosterically modulates nicotinic acetylcholine receptors. This dual mechanism of action provided the rationale for a phase II trial of galantamine in AD.Method: A multicentre, randomized, parallel, double‐blind, placebo‐controlled trial was carried out to evaluate the efficacy and tolerability of galantamine 18, 24 and 36 mg/day administered for 3 months in 285 patients with mild‐to‐moderate probable AD. The primary outcome measure was the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS‐cog); secondary outcome measures were the Clinical Global Impression of Change (CGIC) and the Progressive Deterioration Scale (PDS).Results: Patients treated with galantamine 24 mg/day had a significantly better outcome than placebo on ADAS‐cog; the treatment difference was 3 points on the intention‐to‐treat (ITT) analysis ( p = 0.01) and 4.2 points on per protocol analysis ( p = 0.001). Per protocol analysis showed that galantamine had a significantly better outcome than placebo on PDS ( 24‐mg/day dose, p < 0.05) and CGIC (36‐mg/day dose, p < 0.05). Galantamine was well tolerated at the lower doses of 18 and 24 mg/day where it produced mild, transient effects typical of cholinomimetic agents.Conclusion: This study shows that, relative to placebo, galantamine significantly improves the core symptoms of Alzheimer's disease. Copyright © 2001 John Wiley & Sons, Ltd.