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Three randomized, parallel group, double-blind, placebo-controlled trials
  • All trials positive on several domains
    • Two studied memantine monotherapy
    • Phase 3, multicenter, randomized, double-blind, placebo-controlled trial performed in the United States with 252 outpatients with moderate to severe AD (Reisberg, etal)
    • Phase 3, double-blind, placebo-controlled trial of memantine 10 mg vs placebo in 166 moderately severe to severely demented, care-dependent nursing home patients (Winblad, etal)
  • One studied patients receiving a stable dose of donepezil (Tariot, etal)
    • The study was a prospective, randomized, double-blind, parallel-group, multicenter, 24-week study comparing placebo to memantine treatment in patients with moderate to severe AD already stabilized on donepezil.
    • This study represents the first controlled trial to examine the safety and efficacy of treatment with an NMDA-receptor antagonist and a cholinesterase inhibitor in patients with AD.
    • The overall objective of this study was to determine if memantine was more beneficial than donepezil in patients with moderate to severe AD.
  • Variety of patient settings (outpatients, inpatients)
  • MMSE scores indicative of moderate to severe AD
  • Trial duration ranged from 12-28 weeks
  • Double-blind portion of trials represented a total of 410 patients treated with memantine