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A 24-Week Open-Label Extension Study of Memantine in Moderate to Severe Alzheimer Disease
Barry Reisberg, MD;
Rachelle Doody, MD, PhD;
Albrecht Stöffler, MD;
Frederick Schmitt, PhD;
Steven Ferris, PhD;
Hans Jörg Möbius, MD, PhD
Arch Neurol. 2006;63:49-54.
Background This study is an extension of a 28-week, randomized, double-blind, placebo-controlled study of memantine in 252 patients with moderate to severe Alzheimer disease.
Objective To evaluate long-term memantine treatment in moderate to severe Alzheimer disease.
Design, Setting, and Patients Open-label, 24-week extension trial. Raters remained blind to the patients' initial study treatment. Patients (n = 175) were enrolled from the previous double-blind study in an outpatient setting.
Intervention Twenty mg of memantine was given daily.
Main Outcome Measures Efficacy assessments from the double-blind study were continued and safety parameters were monitored.
Results Patients who switched to memantine treatment from their previous placebo therapy experienced a significant benefit in all main efficacy assessments (functional, global, and cognitive) relative to their mean rate of decline with placebo treatment during the double-blind period (P<.05). The completion rate for the extension phase of the study was high (78%) and the favorable adverse event profile for memantine therapy was similar to that seen in the double-blind study.
Conclusion These results extend previous findings that demonstrated the efficacy and safety of memantine in the treatment of patients with moderate to severe Alzheimer disease.
Author Affiliations: Department of Psychiatry, New York University School of Medicine, New York (Drs Reisberg and Ferris); Department of Neurology, Baylor College of Medicine, Houston, Tex (Dr Doody); Merz Pharmaceuticals GmbH, Frankfurt, Germany (Drs Stöffler and Möbius); Departments of Neurology and Psychiatry, Sanders-Brown Center on Aging, University of Kentucky, Lexington (Dr Schmitt).
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