Journal
ARCHIVES OF NEUROLOGY
Volume 63, Issue 1, Pages 49-54Publisher
AMER MEDICAL ASSOC
DOI: 10.1001/archneur.63.1.49
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Funding
- NATIONAL INSTITUTE ON AGING [R01AG003051, U01AG010483, P30AG008051] Funding Source: NIH RePORTER
- NIA NIH HHS [AG-08051, AG-03051, 1-U02AG-10483] Funding Source: Medline
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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.
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