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Effect of donepezil on cognition in severe Alzheimer's disease: a pooled data analysis.
J Alzheimers Dis 2010; 21(3):843-51JA

Abstract

To better characterize response to donepezil in patients with severe AD, Severe Impairment Battery (SIB) data were pooled from four donepezil clinical trials (N=904). Changes in SIB total and domain scores from baseline to week 24 were compared between placebo and donepezil treatment groups (observed case analysis). Analyses were stratified by baseline severity (Mini-Mental State Examination [MMSE] scores 1-5, 6-9, 10-12 and 13-17) to allow investigation of responses at different stages of cognitive impairment. Relationships to global and functional measures were explored. The difference between donepezil- and placebo-treated patients in least squares (LS) mean change in SIB total scores from baseline to week 24 was 6.22 (p < 0.0001, Cohen's d, 0.53). Treatment-placebo differences were statistically significant for each baseline severity stratum, being greatest for the MMSE 6-9 stratum (LS mean difference, 7.60; p < 0.0001, Cohen's d, 0.66). Treatment-placebo differences in LS mean change in SIB domain scores significantly favored donepezil for seven of nine domains (range, p = 0.0056 to p < 0.0001; Cohen's d, 0.17-0.48). Change in total SIB score correlated significantly with change in measures of activities of daily living and global status. These results indicate that donepezil provides cognitive benefits in patients with severe AD, including those most markedly impaired. The treatment effect size and correlation between improvements in SIB scores and functional and global outcome measures suggest the drug-placebo differences are clinically meaningful.

Authors+Show Affiliations

Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas, NV, USA. jcummings@mednet.ucla.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20634594

Citation

Cummings, Jeffrey, et al. "Effect of Donepezil On Cognition in Severe Alzheimer's Disease: a Pooled Data Analysis." Journal of Alzheimer's Disease : JAD, vol. 21, no. 3, 2010, pp. 843-51.
Cummings J, Jones R, Wilkinson D, et al. Effect of donepezil on cognition in severe Alzheimer's disease: a pooled data analysis. J Alzheimers Dis. 2010;21(3):843-51.
Cummings, J., Jones, R., Wilkinson, D., Lopez, O., Gauthier, S., Waldemar, G., ... Mackell, J. (2010). Effect of donepezil on cognition in severe Alzheimer's disease: a pooled data analysis. Journal of Alzheimer's Disease : JAD, 21(3), pp. 843-51. doi:10.3233/JAD-2010-100078.
Cummings J, et al. Effect of Donepezil On Cognition in Severe Alzheimer's Disease: a Pooled Data Analysis. J Alzheimers Dis. 2010;21(3):843-51. PubMed PMID: 20634594.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of donepezil on cognition in severe Alzheimer's disease: a pooled data analysis. AU - Cummings,Jeffrey, AU - Jones,Roy, AU - Wilkinson,David, AU - Lopez,Oscar, AU - Gauthier,Serge, AU - Waldemar,Gunhild, AU - Zhang,Richard, AU - Xu,Yikang, AU - Sun,Yijun, AU - Richardson,Sharon, AU - Mackell,Joan, PY - 2010/7/17/entrez PY - 2010/7/17/pubmed PY - 2011/1/19/medline SP - 843 EP - 51 JF - Journal of Alzheimer's disease : JAD JO - J. Alzheimers Dis. VL - 21 IS - 3 N2 - To better characterize response to donepezil in patients with severe AD, Severe Impairment Battery (SIB) data were pooled from four donepezil clinical trials (N=904). Changes in SIB total and domain scores from baseline to week 24 were compared between placebo and donepezil treatment groups (observed case analysis). Analyses were stratified by baseline severity (Mini-Mental State Examination [MMSE] scores 1-5, 6-9, 10-12 and 13-17) to allow investigation of responses at different stages of cognitive impairment. Relationships to global and functional measures were explored. The difference between donepezil- and placebo-treated patients in least squares (LS) mean change in SIB total scores from baseline to week 24 was 6.22 (p < 0.0001, Cohen's d, 0.53). Treatment-placebo differences were statistically significant for each baseline severity stratum, being greatest for the MMSE 6-9 stratum (LS mean difference, 7.60; p < 0.0001, Cohen's d, 0.66). Treatment-placebo differences in LS mean change in SIB domain scores significantly favored donepezil for seven of nine domains (range, p = 0.0056 to p < 0.0001; Cohen's d, 0.17-0.48). Change in total SIB score correlated significantly with change in measures of activities of daily living and global status. These results indicate that donepezil provides cognitive benefits in patients with severe AD, including those most markedly impaired. The treatment effect size and correlation between improvements in SIB scores and functional and global outcome measures suggest the drug-placebo differences are clinically meaningful. SN - 1875-8908 UR - https://www.unboundmedicine.com/medline/citation/20634594/Effect_of_donepezil_on_cognition_in_severe_Alzheimer's_disease:_a_pooled_data_analysis_ L2 - https://content.iospress.com/openurl?genre=article&amp;id=doi:10.3233/JAD-2010-100078 DB - PRIME DP - Unbound Medicine ER -