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P4-232: A 24-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of the rivastigmine patch in Japanese patients with Alzheimer's disease

2011; Wiley; Volume: 7; Issue: 4S_Part_22 Linguagem: Inglês

10.1016/j.jalz.2011.05.2257

1552-5279

Yu Nakamura, Yukimichi Imai, Masahiro Shigeta, Ana Graf, Toru Shirahase, Hyosung Kim, Akifumi Fujii, Joji Mori, Akira Homma,

Dementia and Cognitive Impairment Research

As of 2010, rivastigmine patch was licensed for the treatment of Alzheimer's disease (AD) in 64 countries, including those in the EU and the USA. The current study was designed to evaluate the efficacy, safety and tolerability of the 5 cm2 and 10 cm2 rivastigmine patch in Japanese patients with AD. > This was a 24-week, multicenter, randomized, double-blind, placebo-controlled study of the 5 cm2 (4.6 mg/24 h delivery rate) and 10 cm2 (9.5 mg/24 h delivery rate) rivastigmine patch in Japanese patients with AD. Eligible participants were outpatients aged 50-85 years, with a diagnosis of dementia of the Alzheimer's type and a Mini-Mental State Examination score of 10-20. Participants were randomized to treatment and titrated to their target patch dose in 2.5 cm2 increments every 4 weeks, from a starting size of 2.5 cm2. Primary efficacy assessments were the Japanese versions of the AD Assessment Scale-cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC plus-J). Week 24 changes from baseline on the ADAS-J cog were assessed by ANCOVA, with baseline values as covariates. Treatment comparisons on the CIBIC plus-J used the Wilcoxon rank sum test. CIBIC plus-J subscale (Disability Assessment for Dementia, DAD; Behavioral Pathology in AD, BEHAVE-AD; and Mental Function Impairment Scale, MENFIS) scores were secondary efficacy assessments. Of 859 randomized participants, 284 were allocated to 5 cm2 rivastigmine patch, 287 to 10 cm2 rivastigmine patch, and 288 to placebo. In the primary analysis population (ITT-LOCF, n = 810) at Week 24, improvements were seen with the 10 cm2 patch versus placebo on the ADAS-J cog (p = 0.005) and CIBIC plus-J (p = 0.067). Statistical significance for the CIBIC plus-J was achieved following adjustment for dynamic allocation factors (p = 0.042) and on the DAD (p = 0.024) and MENFIS (p = 0.016) subscales. Relevant post-hoc analyses will also be presented. Serious adverse events were rare and were consistent with the known safety profile of rivastigmine patch. This study showed that rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with mild to moderately severe AD, and demonstrated its potential for the treatment of Japanese patients with AD.