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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n\u003Cp id=\u0022p-1\u0022\u003EThis article presents data from the Investigation of Transdermal Exelon in Alzheimer\u0027s disease [IDEAL] trial. Rivastigmine is an acetylcholinesterase inhibitor approved for the treatment of mild to moderate dementia in both Alzheimer\u0027s disease and Parkinson\u0027s disease. Rivastigmine is currently available in capsule formulation, and its pharmacological characteristics are compatible with transdermal delivery. The IDEAL study was conducted to determine whether the efficacy and safety of a transdermal formulation of rivastigmine would be equivalent to the oral formulation, and to collect long-term safety data.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EExtrapyramidal \u0026amp; Movement Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECognitive Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDementias Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EGeorge Grossberg, MD, St. Louis University, presented data from the Investigation of Transdermal Exelon in Alzheimer\u0027s disease (IDEAL) trial. Rivastigmine (Exelon) is an acetylcholinesterase inhibitor approved for the treatment of mild to moderate dementia in both Alzheimer\u0027s disease (AD) and Parkinson\u0027s disease. Rivastigmine is currently available in capsule formulation, and its pharmacological characteristics are compatible with transdermal delivery. Advantages associated with transdermal therapy include better compliance, greater consistency in plasma levels of drug, and a decrease in time to maximal therapeutic concentrations (Cevc G \u003Cem\u003EExpert Opin Investig Drugs\u003C\/em\u003E 1997;6:1887\u20131937). The IDEAL study was conducted to determine whether the efficacy and safety of a transdermal formulation of rivastigmine would be equivalent to the oral formulation, and to collect long-term safety data.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EPatients aged 50\u201385 with a diagnosis of AD were included in the trial, which consisted of a 24-week randomized, double-blind, placebo-controlled phase, followed by a 28-week open-label extension phase (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The primary efficacy measures were the Alzheimer\u0027s disease Assessment Scale-cognitive subscale (ADAS-cog) and the Alzheimer\u0027s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). Skin irritation and patch adhesions were systematically assessed.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/2\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022IDEAL Study Design.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1542702082\u0022 data-figure-caption=\u0022IDEAL Study Design.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/2\/14\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/2\/14\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/2\/14\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11072\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-4\u0022 class=\u0022first-child\u0022\u003EIDEAL Study Design.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-5\u0022\u003EA total of 1,195 patients were randomized to treatment in the double-blind phase, with 970 (81%) completing all 24 weeks; 870 (73%) patients continued into the open-label phase. During the double-blind phase of the study, 83.8% of patients in the 10 cm\u003Csup\u003E2\u003C\/sup\u003E patch group met the target dose of study drug for \u22658 weeks, compared to 49.5% of the capsule group and 53.1% of the 20mg\u003Csup\u003E2\u003C\/sup\u003E groups. At the end of the 24-week double-blind phase, the rivastigmine 10 cm\u003Csup\u003E2\u003C\/sup\u003E patch, 20 cm\u003Csup\u003E2\u003C\/sup\u003E patch, and capsule treatment groups were significantly better than placebo in ADAS-cog, ADCS-Activities of Daily Living scale, Mini-Mental Status Exam, Trail Making Test A, and ADCS-CGIC (all p\u0026lt;0.05), with the exception of the 20 cm\u003Csup\u003E2\u003C\/sup\u003E patch in the ADCS-CGIC (p=0.054). During the open-label phase, 72.6% of participants achieved the target 20 cm\u003Csup\u003E2\u003C\/sup\u003E patch. At the end of the open-label phase, patients who received rivastigmine in any form during the double-blind treatment period had small declines in the ADAS-cog when compared to baseline (\u22120.3); those taking placebo in the double-blind phase had a \u22120.9 change in ADA-cog scores compared to baseline. The most common adverse events associated with rivastigmine were nausea, vomiting, and diarrhea; The 10 cm\u003Csup\u003E2\u003C\/sup\u003E rivastigmine patch had 3 times fewer nausea and vomiting adverse events compared to rivastigmine capsule (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). The open-label phase adverse events were similar to those reported in the double-blind phase. Patients taking placebo in the double-blind phase had a higher incidence of adverse events when switched directly to the 10 mg\u003Csup\u003E2\u003C\/sup\u003E patch, suggesting that na\u00efve patients should be titrated using a 5 cm\u003Csup\u003E2\u003C\/sup\u003E patch. Local skin irritation led to study discontinuation in 2.4% of the 10 cm\u003Csup\u003E2\u003C\/sup\u003E group and 3.7% in the 20 cm\u003Csup\u003E2\u003C\/sup\u003E group. The majority of patients (\u0026gt;90%) experienced \u201cnone, slight, or mild\u201d skin irritation as their most severe skin reaction during the study. Ninety-six percent (96%) of caregivers in the 10 mg\u003Csup\u003E2\u003C\/sup\u003E group reported good adhesion over 24 hours, with the patch staying completely on or just starting to lift up at the corners. The conclusion of the study was that transdermal rivastigmine treatment over one year was a convenient, effective, and well-tolerated medication delivery method in patients with AD.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11076\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11076\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11076\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EMost Frequently Reported Adverse Events (n, %) During the Double-Blind Phase and During the First Four Weeks of the Open-Label Extension Phase Presented by the Patient\u0027s Double-Blind Phase Treatment Group.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2007 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/7\/2\/14.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzmap2\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmap2\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzmap2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}