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ABSTRACT: 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.
SUBMITTER: Nakamura Y
PROVIDER: S-EPMC3199883 | biostudies-literature | 2011 Jan
REPOSITORIES: biostudies-literature
Nakamura Yu Y Imai Yukimichi Y Shigeta Masahiro M Graf Ana A Shirahase Toru T Kim Hyosung H Fujii Akifumi A Mori Joji J Homma Akira A
Dementia and geriatric cognitive disorders extra 20110101 1
<h4>Background</h4>As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer's disease (AD) in 64 countries.<h4>Methods</h4>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.<h4>Results</h4>In the primary analysis population (intent ...[more]