Memantine in severe dementia: results of the 9M-Best Study (Benefit and efficacy in severely demented patients during treatment with memantine).

摘要: Objectives. To assess clinical efficacy and safety of memantine - an uncompetitive N-methyl-D-aspartate (NMDA) antagonist in moderately severe to primary dementia. Materials methods. Dementia was defined by DSM-III-R criteria severity assessed the Global Deterioration Scale (stages 5-7) Mini-Mental State Examination (< 10 points). Primary endpoints were Clinical Impression Change (CGI-C) rated physician, Behavioural Rating for Geriatric Patients (BGP), subscore 'care dependence', nursing staff. Secondary included modified D-Scale (Arnold/Ferm) Results. The ITT sample comprised 166 patients 151 treated per protocol. At 12-week endpoint analysis, 82 received mg day, 84 placebo. 49% Alzheimer type 51% vascular (CT. Hachinski score). A positive response CGI-C seen 73% versus 45% favour (stratifiec Wilcoxon p < 0.001) independent etiology results BGP dependence 3.1 points improvement under 1.1 placebo (p 0.016). coincident two target variables observed 61.3% (memantine) 31.6% (placebo). analysis assessing basic ADL functions support results. Regarding profile, no significant differences between treatment groups observed. Conclusions. this trial hypothesis that leads functional reduces care severely demented patients.