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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


Nakamura, Yu, Kitamura, Shin, Homma, Akira, Shiosakai, Kazuhito, Matsui, Daiju


Expert Opinion On Pharmacotherapy, Volume: 15, No.: 7, Pages.: 913-925

Year of Publication



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.; Objectives: 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.; Conclusion: 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.;

Bibtex Citation

@article{Nakamura_2014, doi = {10.1517/14656566.2014.902446}, url = {}, year = 2014, month = {mar}, publisher = {Informa Healthcare}, volume = {15}, number = {7}, pages = {913--925}, author = {Yu Nakamura and Shin Kitamura and Akira Homma and Kazuhito Shiosakai and Daiju Matsui}, title = {Efficacy and safety of memantine in patients with moderate-to-severe Alzheimer{textquotesingle}s disease: results of a pooled analysis of two randomized, double-blind, placebo-controlled trials in Japan}, journal = {Expert Opinion on Pharmacotherapy} }


adverse, adverse effects, aged, aged, 80 and over, alzheimer disease, antagonists inhibitors, cognition, double-blind method, drug effects, drug therapy, epidemiology, europe, events, excitatory amino acid antagonists, female, humans, japan, male, memantine, multiple, placebo effect, psychology, receptors nmethyldaspartate, speech, therapeutic use, trials

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Behaviour, Cognition, Other