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Memantine Monotherapy Shows Impressive Results in Mild to Moderate Alzheimer's: Presented at CINP

By Jill Stein

PARIS, FRANCE -- June 22, 2004 -- Memantine is safe and effective for the treatment of mild to moderate Alzheimer's disease (AD), according to results presented here on June 22nd at the XXIV Collegium Internationale Neuro-psychopharmacologicum Congress.

Memantine is an uncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor with low-moderate affinity that is approved in the United States for the treatment of moderate to severe AD.

Elaine R. Peskind, MD, Professor of Psychiatry, University of Washington, Seattle, reported findings from a phase 3 trial in which 403 patients were randomized to memantine 10 mg BID or placebo.

Subjects were outpatients 50 years or older who had a diagnosis of probable AD according to criteria set out by the National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association, a magnetic resonance imaging or computed tomography scan consistent with a diagnosis of probable AD, and a score of 10 to 22 (inclusive) on the Mini-Mental State Exam.

Primary outcome measures were the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) subscale -- a measure of cognition -- and the Clinician's Interview-Based Impression of Change - Plus Caregiver Input (CIBIC-Plus), a measure of global status.

Overall, 82.1% of memantine-treated patients and 82.7% of placebo-treated patients completed the 24-week trial. Memantine-treated patients performed significantly better than placebo-treated patients on the ADAS-cog (P =.003) and the CIBIC-Plus (P =.004).

Patients treated with memantine achieved better behavior scores compared with placebo, as determined by a Statistically significant difference in the change from baseline on the Neuropsychiatric Inventory total score.

The memantine dose was safe and well tolerated, Dr. Peskind said, with similar incidence of treatment-emergent adverse events in the two groups.

"The findings indicate that memantine monotherapy may stabilize cognitive function or delay further decline in patients at early stages of AD," Dr. Peskind noted. "Combining these results with those of previously published data, memantine appears to provide significant benefits to patients at all stages of AD."

The study, which is the first prospective, randomized, placebo-controlled study in the U.S. to examine the benefits of memantine monotherapy in patients with mild to moderate AD, was supported by Forest Laboratories, Inc.


[Presentation title: "Memantine Treatment for Mild to Severe Alzheimer's Disease: Clinical Trials Summary." Abstract #P01-286]

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