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Clinical Trial
. 2001 Sep;16(9):852-7.
doi: 10.1002/gps.409.

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

D Wilkinson  1 , J Murray
Affiliations
Clinical Trial

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

D Wilkinson et al. Int J Geriatr Psychiatry. 2001 Sep.

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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