Galantamine: a randomised, double-blind, dose-finding trial in patients with Alzheimer's disease

Wilkinson, D. and Murray, J. (2001) Galantamine: a randomised, double-blind, dose-finding trial in patients with Alzheimer's disease. International Journal of Geriatric Psychiatry, 16 (9), 852-857. (doi:10.1002/gps.409).

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.

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