Donepezil treatment and alzheimer disease: Can the results of randomized clinical trials be applied to alzheimer disease patients in clinical practice?

Jared R. Tinklenberg, Helena C. Kraemer, Kristine Yaffe, Leslie Ross, Javaid Sheikh, John W. Ashford, Jerome A. Yesavage, Joy L. Taylor

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22 Citations (Scopus)


To determine if results fixtm randomized clinical trials of donepezil in Alzheimer disease (AD) patients can be applied to AD patients in clinical practice by comparing the findings from a Nordic one-year randomized AD donepezil trial with data from a one-year prospective, observational study of AD patients. Methods: AD patients from a consortium of California sites were systematically followed for at least one year. Their treatment regimens, including prescription of donepezil, were determined by their Individual physician according to his or her usual criteria. Results: The 148 California patients treated with donepezil had a oneyear decline of 1.3 (3.5 SD) points on the Mini-Mental State Exam compared to a decline of 33 (4.4 SD) in the 158 ADpatients who received no anti-Alzheimer drugs. The Mini-Mental State Exam decline in Nordic sample was ~0.25 points for the 91 patients receiving donepezil and ~2.2for the 98 placebo patients. The overall effect sizes were estimated at about 0.49 in both studies. The California data were further analyzed using propensity methods; after taking Into account differences that could bias prescribing decisions, benefits associated with taking donepezil remained. Conclusion: A comparison of a randomized clinical trial of donepezil in AD patients and this observational study Indicates that If appropriate methodological and statistical precautions are undertaken, then results from randomized clinical trials can be predictive with AD patients in clinical practice. This California study supports the modest effectiveness of donepezil in AD patients having clinical characteristics similar to those of the Nordic study.

Original languageEnglish
Pages (from-to)953-960
Number of pages8
JournalAmerican Journal of Geriatric Psychiatry
Issue number11
Publication statusPublished - Nov 2007
Externally publishedYes



  • Alzheimer disease
  • Clinical practice
  • Donepezil effectiveness
  • Observational studies
  • Propensity analyses

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Geriatrics and Gerontology

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