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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 withmemantine
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