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).

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Original Publication URL: http://dx.doi.org/10.1002/gps.409

Description/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.

Item Type: Article
Related URLs:
Keywords: galantamine, dementia, Alzheimer's disease, acetylcholinesterase inhibitor
Subjects: R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
R Medicine > RM Therapeutics. Pharmacology
Divisions: University Structure - Pre August 2011 > School of Medicine > Clinical Neurosciences
ePrint ID: 27742
Date Deposited: 27 Apr 2006
Last Modified: 27 Mar 2014 18:16
Contact Email Address: dwilk2000@aol.com
URI: http://eprints.soton.ac.uk/id/eprint/27742

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