{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T14:57:44Z","timestamp":1785164264336,"version":"3.55.0"},"reference-count":12,"publisher":"SAGE Publications","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAD"],"published-print":{"date-parts":[[2023,10,10]]},"abstract":"<jats:p>Background: Oral formulations are not suitable for demented patients with dysphagia, those refuse to take tablets, or those with drug compliance problem. However, only oral formulations of donepezil hydrochloride are approved for the treatment of severe Alzheimer\u2019s disease in Japan. Objective: To evaluate the safety, tolerability, and efficacy of long-term application of a 55.0\u200amg transdermal donepezil patch switched from a 10\u200amg oral donepezil hydrochloride tablet, for the treatment of patients with severe Alzheimer\u2019s disease. Methods: A 52-week, multicenter, open-label, uncontrolled (phase III) study (jRCT2080224612) was conducted in Japan between April 2019 and August 2021. A 10\u200amg donepezil hydrochloride tablet was administered once a day for four weeks; a 55.0\u200amg donepezil patch was then applied once a day for 52 weeks in patients with severe Alzheimer\u2019s disease. Results: Of 64 patients received the patch, 45 completed the 52-week period. The overall discontinuation rate was 29.7% (19\/64). Among the 19 patients discontinued, six patients 9.4% (6\/64) discontinued due to adverse events. The incidence of adverse events at application sites was 67.2% (43\/64), including application site erythema 29.7% (19\/64), application site pruritus 25.0% (16\/64), and contact dermatitis 20.3% (13\/64). Adverse events were mild and did not increase with time, demonstrating a favorable safety profile. Cognitive function, measured using the Mini-Mental State Examination, was maintained for up to 24 weeks. Conclusions: Adverse events were considered manageable in a clinical setting. The long-term application of a 55.0\u200amg donepezil patch once a day was feasible treatment in patients with severe Alzheimer\u2019s disease.<\/jats:p>","DOI":"10.3233\/jad-230386","type":"journal-article","created":{"date-parts":[[2023,9,12]],"date-time":"2023-09-12T13:40:28Z","timestamp":1694526028000},"page":"1535-1543","source":"Crossref","is-referenced-by-count":2,"title":["Long-Term Safety, Tolerability, and Efficacy of a Transdermal Donepezil Patch in Patients with Severe Alzheimer\u2019s Disease"],"prefix":"10.1177","volume":"95","author":[{"given":"Yu","family":"Nakamura","sequence":"first","affiliation":[{"name":"Department of Neuropsychiatry, Faculty of Medicine, Kagawa University, Kagawa, Japan"},{"name":"Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Hyogo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohei","family":"Narita","sequence":"additional","affiliation":[{"name":"Teikoku Seiyaku Co., Ltd., Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rei","family":"Kim","sequence":"additional","affiliation":[{"name":"Teikoku Seiyaku Co., Ltd., Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Nishiyama","sequence":"additional","affiliation":[{"name":"Teikoku Seiyaku Co., Ltd., Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Kikuchi","sequence":"additional","affiliation":[{"name":"Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Hyogo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ichiro","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Department of Neuropsychiatry, Faculty of Medicine, Kagawa University, Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Aoki","sequence":"additional","affiliation":[{"name":"Teikoku Seiyaku Co., Ltd., Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","reference":[{"key":"10.3233\/JAD-230386_ref1","doi-asserted-by":"crossref","first-page":"1917","DOI":"10.1093\/brain\/awy132","article-title":"The cholinergic system in the pathophysiology and treatment of Alzheimer\u2019s disease","volume":"141","author":"Hampel","year":"2018","journal-title":"Brain"},{"key":"10.3233\/JAD-230386_ref2","doi-asserted-by":"crossref","first-page":"101","DOI":"10.2174\/1570159X13666150716165726","article-title":"Alzheimer\u2019s disease: Targeting the cholinergic system.","volume":"14","author":"Ferreira-Vieira","year":"2016","journal-title":"Curr Neuropharmacol"},{"key":"10.3233\/JAD-230386_ref3","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1212\/WNL.50.1.136","article-title":"A 24-week, 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