Extended-Release Memantine Safe and Effective for Moderate to Severe Alzheimer's Disease: Presented at ANA

To print: Select File and then Print from your browser's menu
---------------------------------------------------------------------------------------
Title: Extended-Release Memantine Safe and Effective for Moderate to Severe Alzheimer's Disease: Presented at ANA
URL: http://www.pslgroup.com/dg/22D752.htm
Doctor's Guide
September 24, 2008

By Andrew N. Wilner, MD

SALT LAKE CITY, Utah -- September 24, 2008 – Extended-release memantine has been shown to improve global clinical status and cognitive performance compared to placebo in patients with moderate to severe Alzheimer's disease (AD), according to study results presented here at the American Neurological Association (ANA) 133rd Annual Meeting.

Lead author of the study, George Grossberg, MD, Saint Louis University, St. Louis, Missouri, noted that immediate-release memantine is the only N-methyl-D-aspartate (NMDA) receptor antagonist that is currently approved by the US Food and Drug Administration for the treatment of moderate to severe Alzheimer's disease, and it is often used in conjunction with an acetylcholinesterase inhibitor.

The maximum recommended dose of immediate-release memantine is 10 mg twice daily, however, while extended-release memantine is designed for once-daily administration as a 28-mg tablet.

In this multicentre, double-blind, parallel-group trial, presented here on September 22 at a poster session, 342 patients were randomised to receive extended-release memantine 28 mg/day and 335 were randomised to placebo for 24 weeks.

Subjects were at least 50 years old with a diagnosis of probable Alzheimer's disease and a Mini-Mental State Examination (MMSE) ranging from 3 to 14 (on a scale of 0-30), and had to have been on stable anticholinesterase therapy for at least 3 months. The enrolled subjects in each arm of the study were well matched for age and gender in each arm, with the average age in the mid-70s and over 70% being female.

In the treatment group, over the course of 4 weeks, extended-release memantine was titrated by 7 mg each week to a final dose of 28 mg/day.

At study endpoint, the extended-release memantine group scored significantly higher than the placebo group on the Severe Impairment Battery test of cognitive function, with a mean difference of 2.6 change from baseline (P = .001). In addition, the extended-release memantine group also scored significantly higher than the placebo group on the Clinician's Interview-Based Impression of Change Plus Caregiver Input scale, which assesses global clinical status (P = .008).

Secondary outcomes were also superior for those receiving extended-release memantine, based on the Neuropsychiatric Inventory (P = .005) and verbal fluency (P = .004).

There was no statistical difference between the extended-release memantine group and the placebo group on the 19-item AD Cooperative Study-Activities of Daily Living scale.

Thirty-four (10%) of the extended-release memantine subjects discontinued the trial due to adverse effects compared to 21 (6.3%) of the placebo subjects. Headache (5.6%), diarrhoea (5%), and dizziness (4.7%) were the most common adverse events in the extended-release memantine group.

Dr. Grossberg concluded, "Extended-release memantine is at least as efficacious and well tolerated as immediate-release memantine, with overall side effects similar to placebo."

Funding for this study was provided by Forest Laboratories Inc.

[Presentation title: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial of Memantine Extended-Release Capsule in Patients With Moderate to Severe Alzheimer's Disease. Abstract T-28]

http://www.docguide.com

Return to News Story Page

webmaster@pslgroup.com