{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T11:05:55Z","timestamp":1789470355760,"version":"build-2803163510"},"reference-count":32,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2013,8,7]],"date-time":"2013-08-07T00:00:00Z","timestamp":1375833600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["CNS Neurosci Ther"],"published-print":{"date-parts":[[2013,10]]},"abstract":"Summary<\/jats:title>\n \n Aims<\/jats:title>\n \n The 24\u2010week, prospective, randomized, double\u2010blind\n ACTION<\/jats:styled-content>\n study investigated the efficacy, safety, and tolerability of 13.3 versus 4.6\u00a0mg\/24\u00a0h rivastigmine patch in patients with severe Alzheimer's disease (\n AD<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Patients had probable\n AD<\/jats:styled-content>\n and Mini\u2013Mental State Examination scores \u22653\u2013\u226412. Primary outcome measures were as follows: Severe Impairment Battery (\n SIB<\/jats:styled-content>\n ) and\n AD<\/jats:styled-content>\n Cooperative Study\u2013Activities of Daily Living scale\u2013Severe Impairment Version (\n ADCS<\/jats:styled-content>\n \u2010\n ADL<\/jats:styled-content>\n \u2010\n SIV<\/jats:styled-content>\n ). Secondary outcomes were as follows:\n ADCS<\/jats:styled-content>\n \u2010Clinical Global Impression of Change (\n ADCS<\/jats:styled-content>\n \u2010\n CGIC<\/jats:styled-content>\n ), 12\u2010item Neuropsychiatric Inventory (\n NPI<\/jats:styled-content>\n \u201012), and safety\/tolerability.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 1014 patients screened, 716 were randomized to 13.3\u00a0mg\/24\u00a0h (N\u00a0=\u00a0356) or 4.6\u00a0mg\/24\u00a0h (N\u00a0=\u00a0360) patch. Baseline characteristics\/demographics were comparable. Completion rates were as follows: 64.3% (N\u00a0=\u00a0229) with 13.3\u00a0mg\/24\u00a0h and 65.0% (N\u00a0=\u00a0234) with 4.6\u00a0mg\/24\u00a0h patch. The 13.3\u00a0mg\/24\u00a0h patch was significantly superior to 4.6\u00a0mg\/24\u00a0h patch on cognition (\n SIB<\/jats:styled-content>\n ) and function (\n ADCS<\/jats:styled-content>\n \u2010\n ADL<\/jats:styled-content>\n \u2010\n SIV<\/jats:styled-content>\n ) at Week 16 (\n P\u00a0<\/jats:italic>\n <\n \u00a0<\/jats:italic>\n 0.0001 and\n P\u00a0<\/jats:italic>\n =\n \u00a0<\/jats:italic>\n 0.049, respectively) and 24 (primary endpoint;\n P<\/jats:italic>\n \u00a0<\u00a00.0001 and\n P<\/jats:italic>\n \u00a0=\u00a00.025). Significant between\u2010group differences (Week 24) were observed on the\n ADCS<\/jats:styled-content>\n \u2010\n CGIC<\/jats:styled-content>\n (\n P<\/jats:italic>\n \u00a0=\u00a00.0023), not\n NPI<\/jats:styled-content>\n \u201012 (\n P<\/jats:italic>\n \u00a0=\u00a00.1437). A similar proportion of the 13.3\u00a0mg\/24\u00a0h and 4.6\u00a0mg\/24\u00a0h patch groups reported adverse events (\n AE<\/jats:styled-content>\n s; 74.6% and 73.3%, respectively) and serious\n AE<\/jats:styled-content>\n s (14.9% and 13.6%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n The 13.3\u00a0mg\/24\u00a0h patch demonstrated superior efficacy to 4.6\u00a0mg\/24\u00a0h patch on\n SIB<\/jats:styled-content>\n and\n ADCS<\/jats:styled-content>\n \u2010\n ADL<\/jats:styled-content>\n \u2010\n SIV<\/jats:styled-content>\n , without marked increase in\n AE<\/jats:styled-content>\n s, suggesting higher\u2010dose patch has a favorable benefit\u2010to\u2010risk profile in severe\n AD<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/cns.12158","type":"journal-article","created":{"date-parts":[[2013,8,7]],"date-time":"2013-08-07T11:49:50Z","timestamp":1375876190000},"page":"745-752","source":"Crossref","is-referenced-by-count":66,"title":["A 24\u2010Week, Randomized, Controlled Trial of Rivastigmine Patch 13.3\u00a0mg\/24\u00a0h Versus 4.6\u00a0mg\/24\u00a0h in Severe Alzheimer's Dementia"],"prefix":"10.1111","volume":"19","author":[{"given":"Martin R.","family":"Farlow","sequence":"first","affiliation":[{"name":"Department of Neurology Indiana University School of Medicine Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George T.","family":"Grossberg","sequence":"additional","affiliation":[{"name":"Department of Neurology and Psychiatry St Louis University School of Medicine St Louis MO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carl H.","family":"Sadowsky","sequence":"additional","affiliation":[{"name":"Division of Neurology Nova Southeastern University Fort Lauderdale FL USA"},{"name":"Premiere Research Institute Palm Beach Neurology West Palm Beach FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangyi","family":"Meng","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation East Hanover NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monique","family":"Somogyi","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation East Hanover NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,8,7]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2990.1978.tb00545.x"},{"key":"e_1_2_7_3_1","unstructured":"Exelon\u00ae.US prescribing information.2006. 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