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Arch Neurol. 2006 Jan;63(1):49-54.

A 24-week open-label extension study of memantine in moderate to severe Alzheimer disease.

Author information

1
Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA. barry.reisberg@med.nyu.edu

Abstract

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.

PMID:
16401736
DOI:
10.1001/archneur.63.1.49
[Indexed for MEDLINE]

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