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Long-term safety and efficacy of donepezil in patients with severe Alzheimer’s disease: results from a 52-week, open-label, multicenter, extension study in Japan


Homma, Akira, Imai, Yukimichi, Tago, Hisao, Asada, Takashi, Shigeta, Masahiro, Iwamoto, Toshihiko, Takita, Masashi, Arimoto, Itaru, Koma, Hiroshi, Takase, Takao, Ohbayashi, Toshio


Dementia And Geriatric Cognitive Disorders, Volume: 27, No.: 3, Pages.: 232-239

Year of Publication



Background/aims: A 6-month, randomized, double-blind, placebo-controlled study was extended to evaluate long-term safety and efficacy of donepezil in community-dwelling Japanese patients with severe Alzheimer’s disease (AD).; Methods: 189 patients were enrolled from the double-blind study into a 52-week, open-label extension study. After a 2- to 8-week washout, donepezil was escalated within 6 weeks to 10 mg/day. Main outcomes were Severe Impairment Battery (SIB), Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale for severe AD (ADCS-ADL-sev) and Behavioral Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD). Safety parameters were monitored throughout.; Results: Overall, mean change from extension study baseline in SIB scores improved until week 24; however, scores were influenced by prior treatment during the double-blind study and by length of washout. Patients treated with donepezil retained some treatment benefits after a washout of 2-4 weeks but lost all treatment benefits after a washout of 4-8 weeks. There was no change in ADCS-ADL-sev or BEHAVE-AD scores. Adverse events were consistent with the known donepezil safety profile.; Conclusion: Donepezil is effective and safe for symptomatic treatment of severe AD for at least 1 year. Patients who receive donepezil 10 mg daily with little or no interruption achieve the best long-term outcome.; Copyright 2009 S. Karger AG, Basel.

Bibtex Citation

@article{Homma_2009, doi = {10.1159/000203887}, url = {}, year = 2009, month = {feb}, publisher = {S. Karger {AG}}, volume = {27}, number = {3}, pages = {232--239}, author = {Akira Homma and Yukimichi Imai and Hisao Tago and Takashi Asada and Masahiro Shigeta and Toshihiko Iwamoto and Masashi Takita and Itaru Arimoto and Hiroshi Koma and Takao Takase and Toshio Ohbayashi}, title = {Long-Term Safety and Efficacy of Donepezil in Patients with Severe Alzheimer's Disease: Results from a 52-Week, Open-Label, Multicenter, Extension Study in Japan}, journal = {Dementia and Geriatric Cognitive Disorders} }


adverse effects, aged, aged, 80 and over, alzheimer disease, cholinesterase inhibitors, donepezil, double-blind method, drug therapy, female, humans, indans, male, nootropic agents, piperidines, psychology, safety, therapeutic use

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition, Other



Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime