When the investigators measured patients' responses on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), "individual ADAS-cog items of commands, orientation, comprehension, and recall of test instructions showed improvement associated with memantine treatment," said Nunzio Pomara, MD, professor of psychiatry, Nathan S. Kline Institute, and director of geriatric psychiatry, New York University School of Medicine, Orangeburg, New York.

He and his co-investigators conducted a 24week, double-blind, phase 3 study to see if the previously documented cognitive effects of memantine continued in long-term treatment, Dr. Pomara noted in his presentation on October 8^th.

They randomized the 403 patients to receive either 20 mg daily of memantine or placebo. They included patients who had either mild or moderate dementia that was probable Alzheimer's disease as defined by a Mini Mental Status Examination (MMSE) score of 10 to 22 and a magnetic resonance imaging (MRI) or computer tomography (CT) scan consistent with a diagnosis of Alzheimer's disease.

The study's primary endpoint was change in cognition as measured by the ADAS-cog, which has 11 items and a score range of 0 to 70, with higher scores indicating greater impairment. The investigators analyzed changes from baseline to the study's end regarding total scores, items, and subscales.

Patients treated with memantine and placebo had similar rates of usage of anti-dementia medications, 62% in the memantine group and 69% in the placebo group. Their baseline scores were an average of 17.4 and 17.2, respectively. Mean baseline ADAS-cog scores were 27.2 and 27.3, respectively.

After 24 weeks of treatment, the ADAS-cog score increased an average of, the score decreased an average of 0.8 points in the memantine group and 11.0 points in the placebo patients who completed treatment (P = .003).

"Memantine-treated patients demonstrated significant improvement over placebo-treated patients at study endpoint on 4 of the 11 items of the ADAS-cog," reported Dr. Pomara. Those items pertained to commands, orientation, comprehension, and recall of test instructions (P < .05). The analysis of the ADAS-cog subscales also showed a significant memantine-associated benefit on memory and language (P = -.01).

The findings show that memantine is associated with cognitive benefits in patients with mild to moderate Alzheimer's disease, the investigators said.

Namenda is manufactured by Forest Laboratories, Inc., which sponsored the study.


[Presentation title: Efficacy of Memantine on Cognition in Mild to Moderate Alzheimers Disease. Abstract S-16]

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