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

• Published in: Dementia and geriatric cognitive disorders extra Vol. 1; no. 1; pp. 163 - 179
• Main Authors: Nakamura, Yu, Imai, Yukimichi, Shigeta, Masahiro, Graf, Ana, Shirahase, Toru, Kim, Hyosung, Fujii, Akifumi, Mori, Joji, Homma, Akira
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland S. Karger AG 24.06.2011; Karger Publishers
• Subjects: Alzheimerߣs disease; Cholinesterase inhibitors; Japanese; Original; Original Research Article; Randomized clinical trial; Rivastigmine; Randomized clinical trial; Rivastigmine; Cholinesterase inhibitors; Japanese; Alzheimerߣs disease; Alzheimer's disease
• ISSN: 1664-5464; 1664-5464
• DOI: 10.1159/000328929

Background: As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer’s disease (AD) in 64 countries. Methods: This 24-week, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the 5-cm 2 (9-mg loading dose; 4.6 mg/24 h delivery rate) and 10-cm 2 (18-mg loading dose; 9.5 mg/24 h delivery rate) rivastigmine patch in Japanese patients with AD. Results: In the primary analysis population (intent-to-treat last observation carried forward) at week 24, delayed deterioration was seen with the 10-cm 2 patch versus placebo on the Japanese version of the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-J cog; p = 0.005) and the Japanese version of the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC plus-J; p = 0.067). Participants receiving the rivastigmine patch showed numerically less decline versus placebo at week 24 on the CIBIC plus-J, although this did not reach statistical significance. Statistical significance for the CIBIC plus-J was met following adjustment for body weight and baseline Mini-Mental State Examination score as dynamic allocation factors (p = 0.042) and on the Disability Assessment for Dementia (DAD; p = 0.024) and Mental Function Impairment (MENFIS; p = 0.016) subscales. Serious adverse events were rare and were consistent with the known safety profile of the rivastigmine patch. Conclusion: The rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with AD.