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Effects of galantamine in patients with mild Alzheimer's disease.
Curr Med Res Opin. 2004 Nov; 20(11):1815-20.CM

Abstract

BACKGROUND

Galantamine is an acetylcholinesterase inhibitor that modulates nicotinic receptors. It is effective in mild to moderate Alzheimer's disease (AD) but no trial has focused exclusively on mild AD. We performed a post-hoc sub-set analysis using data from four randomised trials to explore the efficacy of galantamine versus placebo in mild AD.

METHODS

Participants in all studies met NINCDS-ADRDA criteria for probable AD. We examined data from patients with baseline Mini Mental State Examination (MMSE) 21-24 who received galantamine 24 mg/day (GAL) or placebo (PLAC). Scores for the Alzheimer's Disease Assessment Scale-cognitive subset (ADAS-cog), Clinician's Interview-Based Impression of Change (CIBIC), Disability Assessment for Dementia (DAD), and ACDS-ADL scales were compared.

RESULTS

Of the 694 patients (362 GAL, 332 PLAC, mean baseline MMSE 22.4 +/- 1.1, mean age 74 +/- 7.9 years), 65% completed 6 months treatment (223 GAL, 229 PLAC). Mean change in ADAS-cog at 6 months was -1.5 (95% confidence interval -2.2, -0.8, p < 0.001) for GAL and +0.2 (-0.6, 0.9, p = 0.72) for PLAC. This difference was statistically significant (p = 0.001). Significantly more patients receiving galantamine were classified as 'improved' using the CIBIC (26.9% GAL vs 14.3% PLAC, p < 0.001). Galantamine was generally well tolerated; most common adverse events were nausea, vomiting and diarrhoea.

CONCLUSIONS

Pooled data from four randomised trials of patients with mild AD indicate that patients who received galantamine 24 mg/day for 6 months improved cognition more often than those who received placebo and that a higher proportion receiving galantamine were globally improved. This suggests that patients with mild AD benefit from galantamine treatment.

Authors+Show Affiliations

Orgogozo JM
Université de Bordeaux 2-Hôpital Pellegrin, Bordeaux, France.
Small GW
No affiliation info available
Hammond G
No affiliation info available
Van Baelen B
No affiliation info available
Schwalen S
No affiliation info available

MeSH

AgedAlzheimer DiseaseCholinesterase InhibitorsFemaleGalantamineHumansMaleTreatment Outcome

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15537482

Citation

Orgogozo, J-M, et al. "Effects of Galantamine in Patients With Mild Alzheimer's Disease." Current Medical Research and Opinion, vol. 20, no. 11, 2004, pp. 1815-20.
Orgogozo JM, Small GW, Hammond G, et al. Effects of galantamine in patients with mild Alzheimer's disease. Curr Med Res Opin. 2004;20(11):1815-20.
Orgogozo, J. M., Small, G. W., Hammond, G., Van Baelen, B., & Schwalen, S. (2004). Effects of galantamine in patients with mild Alzheimer's disease. Current Medical Research and Opinion, 20(11), 1815-20.
Orgogozo JM, et al. Effects of Galantamine in Patients With Mild Alzheimer's Disease. Curr Med Res Opin. 2004;20(11):1815-20. PubMed PMID: 15537482.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of galantamine in patients with mild Alzheimer's disease. AU - Orgogozo,J-M, AU - Small,G W, AU - Hammond,G, AU - Van Baelen,B, AU - Schwalen,S, PY - 2004/11/13/pubmed PY - 2005/3/18/medline PY - 2004/11/13/entrez SP - 1815 EP - 20 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 20 IS - 11 N2 - BACKGROUND: Galantamine is an acetylcholinesterase inhibitor that modulates nicotinic receptors. It is effective in mild to moderate Alzheimer's disease (AD) but no trial has focused exclusively on mild AD. We performed a post-hoc sub-set analysis using data from four randomised trials to explore the efficacy of galantamine versus placebo in mild AD. METHODS: Participants in all studies met NINCDS-ADRDA criteria for probable AD. We examined data from patients with baseline Mini Mental State Examination (MMSE) 21-24 who received galantamine 24 mg/day (GAL) or placebo (PLAC). Scores for the Alzheimer's Disease Assessment Scale-cognitive subset (ADAS-cog), Clinician's Interview-Based Impression of Change (CIBIC), Disability Assessment for Dementia (DAD), and ACDS-ADL scales were compared. RESULTS: Of the 694 patients (362 GAL, 332 PLAC, mean baseline MMSE 22.4 +/- 1.1, mean age 74 +/- 7.9 years), 65% completed 6 months treatment (223 GAL, 229 PLAC). Mean change in ADAS-cog at 6 months was -1.5 (95% confidence interval -2.2, -0.8, p < 0.001) for GAL and +0.2 (-0.6, 0.9, p = 0.72) for PLAC. This difference was statistically significant (p = 0.001). Significantly more patients receiving galantamine were classified as 'improved' using the CIBIC (26.9% GAL vs 14.3% PLAC, p < 0.001). Galantamine was generally well tolerated; most common adverse events were nausea, vomiting and diarrhoea. CONCLUSIONS: Pooled data from four randomised trials of patients with mild AD indicate that patients who received galantamine 24 mg/day for 6 months improved cognition more often than those who received placebo and that a higher proportion receiving galantamine were globally improved. This suggests that patients with mild AD benefit from galantamine treatment. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/15537482/Effects_of_galantamine_in_patients_with_mild_Alzheimer's_disease_ DB - PRIME DP - Unbound Medicine ER -