Memantine May Be Effective for Mild to Moderate Alzheimer's Disease

Peggy Peck

July 21, 2004

July 21, 2004 (Philadelphia) — Results of a phase III trial of memantine hydrochloride monotherapy in patients with mild to moderate Alzheimer's disease suggest that the drug is effective at all stages of the disease.

Lead investigator Nunzio Pomara, MD, a research professor at the Nathan S. Kline Institute at New York University School of Medicine, said, "This is now our drug of choice in patients who begin to show any mental deterioration." Dr. Pomara presented the findings at the 9th International Conference on Alzheimer's Disease and Related Disorders.

The 24-week, placebo-controlled, randomized study of outpatients with mild to moderate disease found that memantine monotherapy was associated with significant improvement in cognition and observed function. Moreover, the drop-out rate was low, and there were no significant differences in adverse events between the memantine and placebo groups.

Memantine is currently approved for the treatment of moderate to severe Alzheimer's disease.

The study randomized 403 patients to 10 mg of memantine twice daily (n = 201) or placebo (n = 202) for 24 weeks. All patients were aged 50 years or older and met diagnostic criteria for probable Alzheimer's disease with a Mini-Mental Status Examination (MMSE) score of 10 to 22 at baseline.

End points were Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) and clinician assessment of change based on interview plus assessment from the patient's caregiver. The end points were assessed using a last observation carried forward approach.

Dr. Pomara said patients in the memantine group performed significantly better than patients in the placebo group on both primary outcome measures. Those differences were significant for both the ADAS-cog score (P = .003) and the clinician and caregiver assessments (P = .004). He added that the memantine-treated patients were less likely to exhibit agitation or other behavioral disturbances.

During the discussion part of the session, Dr. Pomara said that memantine's effect is usually apparent after four weeks of treatment.

The study was funded by Forest Laboratories, Inc., which manufactures memantine and markets it as Namenda.

9th ICADRD: Abstract 01-05-04. Presented July 18, 2004.

Reviewed by Gary D. Vogin, MD

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