{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:20:27Z","timestamp":1787016027382,"version":"build-2736575974"},"reference-count":37,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,3,4]],"date-time":"2024-03-04T00:00:00Z","timestamp":1709510400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Psychogeriatrics"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Donepezil has been approved in Japan for the treatment of dementia with Lewy bodies (DLB) based on clinical trials showing its beneficial effects on cognitive impairment. This phase IV study evaluated the efficacy of donepezil by focusing on global clinical status during a 12\u2010week double\u2010blind phase.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients with probable DLB were randomly assigned to the placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200979) or 10\u2009mg donepezil (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200981) groups. The primary endpoint was changes in global clinical status, assessed using the Clinician's Interview\u2010Based Impression of Change plus Caregiver Input (CIBIC\u2010plus). We also assessed four CIBIC\u2010plus domains (general condition, cognitive function, behaviour, and activities of daily living) and changes in cognitive impairment and behavioural and neuropsychiatric symptoms measured using the Mini\u2010Mental State Examination (MMSE) and the Neuropsychiatric Inventory (NPI), respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Although donepezil's superiority was not shown in the global clinical status, a significant favourable effect was detected in the cognitive domain (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.006). MMSE scores improved in the donepezil group after adjustments in\n                      <jats:italic>post hoc<\/jats:italic>\n                      analysis (MMSE mean difference, 1.4 (95% confidence interval (CI), 0.42\u20132.30),\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.004). Improvements in NPIs were similar between the groups (NPI\u20102: \u22120.2 (95% CI, \u22121.48 to 1.01),\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.710; NPI\u201010: 0.1 (95% CI, \u22123.28 to 3.55),\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.937).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The results support the observation that the efficacy of 10\u2009mg donepezil in improving cognitive function is clinically meaningful in DLB patients. The evaluation of global clinical status might be affected by mild to moderate DLB patients enrolled in this study. No new safety concerns were detected.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/psyg.13091","type":"journal-article","created":{"date-parts":[[2024,3,4]],"date-time":"2024-03-04T23:34:33Z","timestamp":1709595273000},"page":"542-554","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy and safety of donepezil in patients with dementia with Lewy bodies: results from a 12\u2010week multicentre, randomised, double\u2010blind, and placebo\u2010controlled phase IV study"],"prefix":"10.1111","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4247-9948","authenticated-orcid":false,"given":"Etsuro","family":"Mori","sequence":"first","affiliation":[{"name":"Department of Behavioral Neurology and Neuropsychiatry Osaka University United Graduate School of Child Development  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manabu","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Osaka University Graduate School of Medicine  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eizo","family":"Iseki","sequence":"additional","affiliation":[{"name":"Senior Mental Clinic Nihonbashi Ningyocho  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sadao","family":"Katayama","sequence":"additional","affiliation":[{"name":"Katayama Medical Clinic  Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Nagahama","sequence":"additional","affiliation":[{"name":"Kawasaki Memorial Hospital  Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megumi","family":"Ohdake","sequence":"additional","affiliation":[{"name":"Clinical Planning and Development Department Medical HQs, Eisai Co. 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