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Memantine Monotherapy Useful for Alzheimer' Disease: Presented at AAN

By Jill Stein

SAN FRANCISCO, CA -- April 27, 2004 -- Memantine appears to be effective and safe for the treatment of patients with mild to moderate Alzheimer's disease (AD), according to the results of a phase 3 study presented here on April 27^th at the American Academy of Neurology 56^th Annual Meeting.

Steven G. Potkin, MD, Professor of Psychiatry, Department of Psychiatry and Human Behavior, College of Medicine, University of California at Irvine, presented the findings in 332 patients who had been randomised to 24 weeks' of treatment with memantine 20 mg/day or placebo.

The study included outpatients who were 50 years or older and had a diagnosis of probable AD, a magnetic resonance imaging (MRI) or computed tomography (CT) scan consistent with probable AD, and a Mini-Mental Status Exam (MMSE) score of 10 to 22 at baseline and at screening.

Primary efficacy measures included the following: cognition as assessed by the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) and global status as assessed by the Clinician's Interview-Based Impression of Change – Plus Caregiver Input (CIBIC-Plus).

The researchers found a statistically significant difference in cognitive performance favouring memantine over placebo as measured by the ADAS-cog. Patients treated with memantine improved compared to baseline over the 24-week course of the study, whereas patients who received placebo exhibited progressive cognitive decline over the same time period.

Patients treated with memantine had significantly less decline on global measures of the CIBIC-Plus compared with patients treated with placebo.

Statistically significant superiority in behaviour, measured by the change from baseline in the Neuropsychiatric Inventory (NPI) total score, was observed in patients treated with memantine compared with placebo.

Incidence of treatment-emergent adverse events was similar in patients treated with memantine and placebo. Somnolence was reported by at least 5% of the memantine group and at an incidence greater than twice that of patients treated with placebo. By the same criteria, upper respiratory tract infection and depression were reported by at least 5% of the placebo group and at an incidence greater than twice that of patients treated with memantine.

Dr. Potkin said that the trial is the first prospective, randomised, placebo-controlled study in the United States to examine the benefits of memantine monotherapy in patients with mild to moderate AD. The findings, he added, raise the hope that memantine monotherapy may stabilise cognitive function or delay further decline in patients who are in the early stages of AD.

Memantine is approved in the US for treatment of moderate to severe AD and is currently under investigation for treatment of mild to moderate AD.

The trial was sponsored by Forest Laboratories, Inc.


[Memantine is Effective and Safe for the Treatment of Mild to Moderate Alzheimer's Disease: A Randomized Controlled Trial. Abstract #LBS.003]

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