title: Efficacy and safety of memantine in patients with moderate-to-severe Alzheimer's disease: results of a pooled analysis of two randomized, double-blind, placebo-controlled trials in Japan.
abstract: BACKGROUND
  With the increase in the aging population, there is a pressing need to provide effective treatment options for individuals with Alzheimer's disease (AD). Memantine is an N-methyl-D-aspartate receptor antagonist used to treat AD in > 80 countries worldwide, and studies in the USA and Europe have shown it to be effective in improving language deficits; however, there are currently no data on language improvements in Japanese patients treated with memantine.
  
  
  OBJECTIVE
  To clarify the efficacy and safety of memantine in Japanese outpatients with moderate to severe AD, using a pooled analysis of two multicenter randomized placebo-controlled trials, a phase 2 dose-finding study and a phase 3 study.
  
  
  RESULTS
  The final analysis comprised 633 patients (318 receiving memantine and 315 placebo). Memantine produced better outcomes in terms of Severe Impairment Battery-Japanese version, Clinician's Interview-Based Impression of Change plus-Japanese version, Behavioral Pathology in AD Rating Scale, and language scores, versus placebo. The overall incidence of adverse events and adverse reactions was similar between groups.
  
  
  CONCLUSIONS
  In this pooled analysis of Japanese patients, memantine achieved better outcomes than placebo in terms of cognition, including attention, praxis, visuospatial ability and language, and behavioral and psychological symptoms, including activity disturbances and aggressiveness.
authors.affiliation: Kagawa University, Faculty of Medicine, Department of Neuropsychiatry , 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa , Japan +81 87 898 5111 ; +81 87 891 2016 ; yunaka@med.kagawa-u.ac.jp.
authors.forename: Yu
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Shin
authors.initials: S
authors.lastname: Kitamura
authors.forename: Akira
authors.initials: A
authors.lastname: Homma
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Shiosakai
authors.forename: Daiju
authors.initials: D
authors.lastname: Matsui
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D003071:Cognition / Q000187:drug effects; D004311:Double-Blind Method; D005060:Europe; D018691:Excitatory Amino Acid Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008559:Memantine / Q000009:adverse effects / Q000627:therapeutic use*; D015990:Placebo Effect; D016194:Receptors, N-Methyl-D-Aspartate / Q000037:antagonists & inhibitors*; D013060:Speech / Q000187:drug effects
chemical_list: D018691:Excitatory Amino Acid Antagonists; D016194:Receptors, N-Methyl-D-Aspartate; D008559:Memantine