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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.
Dement Geriatr Cogn Disord 2009; 27(3):232-9DG

Abstract

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.

Authors+Show Affiliations

Dementia Interventional Research Group, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan. ahomma@tmig.or.jpNo 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
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19246907

Citation

Homma, Akira, et al. "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." Dementia and Geriatric Cognitive Disorders, vol. 27, no. 3, 2009, pp. 232-9.
Homma A, Imai Y, Tago H, et al. 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. Dement Geriatr Cogn Disord. 2009;27(3):232-9.
Homma, A., Imai, Y., Tago, H., Asada, T., Shigeta, M., Iwamoto, T., ... Ohbayashi, T. (2009). 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. Dementia and Geriatric Cognitive Disorders, 27(3), pp. 232-9. doi:10.1159/000203887.
Homma A, et al. 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. Dement Geriatr Cogn Disord. 2009;27(3):232-9. PubMed PMID: 19246907.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Homma,Akira, AU - Imai,Yukimichi, AU - Tago,Hisao, AU - Asada,Takashi, AU - Shigeta,Masahiro, AU - Iwamoto,Toshihiko, AU - Takita,Masashi, AU - Arimoto,Itaru, AU - Koma,Hiroshi, AU - Takase,Takao, AU - Ohbayashi,Toshio, Y1 - 2009/02/25/ PY - 2008/10/22/accepted PY - 2009/2/28/entrez PY - 2009/2/28/pubmed PY - 2009/5/29/medline SP - 232 EP - 9 JF - Dementia and geriatric cognitive disorders JO - Dement Geriatr Cogn Disord VL - 27 IS - 3 N2 - 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. SN - 1421-9824 UR - https://www.unboundmedicine.com/medline/citation/19246907/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_ L2 - https://www.karger.com?DOI=10.1159/000203887 DB - PRIME DP - Unbound Medicine ER -