A six‐month double‐blind, randomized, placebo‐controlled study of a transdermal patch in Alzheimer's disease–– rivastigmine patch versus capsule

Abstract Objectives To compare the efficacy, safety and tolerability of a novel rivastigmine transdermal patch with conventional rivastigmine capsules and placebo in patients with Alzheimer's disease (AD). Methods In this 24‐week, multicenter, double‐blind, double‐dummy, placebo‐ and active‐controlled trial, patients with probable AD were randomized to one of four treatment groups: 12 mg/day rivastigmine capsules; 10 cm 2 (9.5 mg/24 h) rivastigmine patch; 20 cm 2 (17.4 mg/24 h) rivastigmine patch; or placebo. Primary efficacy measures were the Alzheimer's Disease Assessment Scale—Cognitive subscale (ADAS‐Cog) and Alzheimer's Disease Cooperative Study––Clinical Global Impression of Change (ADCS‐CGIC). Results One thousand one hundred and ninety five AD patients from 21 countries participated in the study. Treatment differences ( vs placebo) on the ADAS‐Cog at Week 24 in 10 cm 2 patch, 20 cm 2 patch and capsule groups were 1.6 ( p = 0.005), 2.6 ( p < 0.001) and 1.6 ( p = 0.003). Treatment differences on the ADCS‐CGIC were 0.3 ( p = 0.01), 0.2 ( p = 0.054) and 0.3 ( p = 0.009). Comparison between the 10 cm 2 patch and the capsule revealed non‐inferiority. Rates of nausea in the 10 cm 2 patch and capsule groups were 7.2% and 23.1%, respectively; rates of vomiting were 6.2% and 17.0%, respectively. Moderate or severe skin irritation occurred in ≤10% patients across the four patch sizes (5, 10, 15 and 20 cm 2 ). Conclusions The target dose of 10 cm 2 rivastigmine patch provides efficacy similar to the highest doses of capsules with a superior tolerability profile. The transdermal patch with rivastigmine may offer convenience important to many caregivers and patients. Copyright © 2007 John Wiley & Sons, Ltd.