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Long-term safety and efficacy of donepezil in patients with dementia with Lewy bodies: results from a 52-week, open-label, multicenter extension study


Ikeda, Manabu, Mori, Etsuro, Kosaka, Kenji, Iseki, Eizo, Hashimoto, Mamoru, Matsukawa, Noriyuki, Matsuo, Kazutaka, Nakagawa, Masaki


Dementia And Geriatric Cognitive Disorders, Volume: 36, No.: 3-4, Pages.: 229-241

Year of Publication



Background/aims: To investigate the safety and efficacy of long-term administration (52 weeks) of donepezil in patients with dementia with Lewy bodies (DLB).; Methods: This was a 52-week, multicenter, open-label extension study. Up to 8 weeks after the completion of the preceding randomized, placebo-controlled trial (RCT), patients started treatment with 3 mg of donepezil daily for 2 weeks, followed by 5 mg daily for the remaining 50 weeks. Cognitive function, behavioral and psychiatric symptoms, cognitive fluctuations, and caregiver burden were assessed using the Mini-Mental State Examination, Neuropsychiatric Inventory, Cognitive Fluctuation Inventory, and the Zarit Caregiver Burden Interview, respectively. Safety parameters were monitored throughout.; Results: In total, 108 patients were enrolled in the study. Cognitive function and dementia-related behavioral symptoms, including cognitive fluctuations, were improved after the start of donepezil treatment, and improvement was maintained for 52 weeks. Reduction in caregiver burden observed in the preceding RCT returned to the baseline level at 52 weeks. There was no significant imbalance in the incidence of adverse events (AEs) by onset time, and delayed AE onset induced by the long-term administration of donepezil was unlikely to appear.; Conclusion: The long-term administration of donepezil at 5 mg/day was well tolerated in patients with DLB and is expected to exhibit lasting effects, improving impaired cognitive function and psychiatric symptoms up to 52 weeks.; © 2013 S. Karger AG, Basel.

Bibtex Citation

@article{Ikeda_2013, doi = {10.1159/000351672}, url = {}, year = 2013, publisher = {S. Karger {AG}}, volume = {36}, number = {3-4}, pages = {229--241}, author = {Manabu Ikeda and Etsuro Mori and Kenji Kosaka and Eizo Iseki and Mamoru Hashimoto and Noriyuki Matsukawa and Kazutaka Matsuo and Masaki Nakagawa}, title = {Long-Term Safety and Efficacy of Donepezil in Patients with Dementia with Lewy Bodies: Results from a 52-Week, Open-Label, Multicenter Extension Study}, journal = {Dementia and Geriatric Cognitive Disorders} }


adverse effects, aged, aged, 80 and over, complications, data interpretation statistical, disease progression, donepezil, double-blind method, drug therapy, female, humans, indans, lewy body disease, male, nootropic agents, parkinson disease, piperidines, psychology, therapeutic use, treatment outcome

Countries of Study


Types of Dementia


Types of Study

Before and After Study

Type of Outcomes

Behaviour, Carer Burden (instruments measuring burden), Cognition, Prevention and/or management of co-morbidities

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

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