title: 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.
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.
  
  
  CONCLUSIONS
  The rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with AD.
authors.affiliation: Department of Neuropsychiatry, Faculty of Medicine, Kagawa University, Kagawa, Tokyo.
authors.forename: Yu
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Yukimichi
authors.initials: Y
authors.lastname: Imai
authors.forename: Masahiro
authors.initials: M
authors.lastname: Shigeta
authors.forename: Ana
authors.initials: A
authors.lastname: Graf
authors.forename: Toru
authors.initials: T
authors.lastname: Shirahase
authors.forename: Hyosung
authors.initials: H
authors.lastname: Kim
authors.forename: Akifumi
authors.initials: A
authors.lastname: Fujii
authors.forename: Joji
authors.initials: J
authors.lastname: Mori
authors.forename: Akira
authors.initials: A
authors.lastname: Homma