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Galantamine for Alzheimer's disease
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.
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.
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.