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April 14, 2004

Memantine for Patients With Alzheimer Disease

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291(14):1695. doi:10.1001/jama.291.14.1695-b

In Reply: Dr Finucane is concerned about our outcome measures. This trial was one of several conducted in order to seek approval of memantine from the US Food and Drug Administration for treatment of moderate to severe AD. In such trials, outcomes of primary significance must be declared in advance; in our trial, these consisted of a direct measure of cognition and an assessment of daily functioning based on caregiver interview. A clinical global impression of change, based on both direct assessment of the patient and interview of the caregiver, was included, as was a caregiver-based measure of neuropsychiatric symptoms. Effectiveness of therapy was established by greater treatment adherence and superior outcomes on all assessments that were performed in those receiving memantine compared with those receiving placebo and by favorable safety and tolerability of memantine. Thus, the clinical relevance from this trial comes from observable cognitive performance and treatment effects that were perceptible to both families and clinicians. These effects were generally consistent with those of an earlier trial of memantine monotherapy in patients with moderate to severe AD.1

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