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Galantamine for Alzheimer's disease.

J Olin¹, L Schneider

¹Adult and Geriatric Treatment and Preventative Interventions Branch, National Institute of Mental Health, NIMH, Room 7160, MSC 9635, 6001 Executive Blvd., Bethesda, Maryland 20892-9635, USA. jolin@mail.nih.gov

The Cochrane Database of Systematic Reviews

|November 1, 2001

Summary

Galantamine demonstrates significant clinical benefits for patients with Alzheimer's disease (AD), improving cognitive function and global ratings in trials lasting 3 to 6 months. Doses of 16-32 mg/day showed efficacy, with 16 mg/day appearing best tolerated.

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Area of Science:

Neuroscience
Pharmacology
Clinical Trials

Background:

Galantamine, a synthesized acetylcholinesterase inhibitor and nicotinic receptor modulator, is approved in 29 countries for Alzheimer's disease (AD).
Early studies suggested mild cognitive and global benefits in AD patients, with recent multicenter trials showing positive findings.

Purpose of the Study:

To assess the clinical effects of galantamine in patients with probable AD.
To investigate potential moderators of galantamine's treatment effect.

Main Methods:

Systematic review of randomized, double-blind, parallel-group trials comparing galantamine to placebo for AD treatment durations exceeding 4 weeks.
Data extraction and pooling of outcomes including ADAS-cog, CIBIC-plus, ADCS-ADL, DAD, and NPI, analyzing trial duration and dose as potential moderators.

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Main Results:

Galantamine (16-32 mg/day) showed significant treatment effects in trials of 3- to 6-months duration for global ratings and cognitive function (ADAS-Cog).
Statistically significant improvements were observed for doses above 8 mg/day, with 16-32 mg/day demonstrating consistent efficacy.
Adverse effects were similar to other cholinesterase inhibitors, primarily gastrointestinal; higher doses (24-32 mg/day) increased discontinuation rates, though slower titration at 16 mg/day improved tolerability.

Conclusions:

Galantamine consistently demonstrated positive effects on global ratings, cognitive tests, and daily living activities in patients with mild to moderate AD over 3- to 6-month trial durations.
The cognitive benefits are comparable to other cholinesterase inhibitors like donepezil, rivastigmine, and tacrine.
A starting dose of 16 mg/day is suggested due to its favorable tolerability and comparable efficacy to higher doses, pending further assessment in more severely impaired subjects.