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From the Departments of Neurology and Psychiatry and Biobehavioral Sciences (J.L.C.), David Geffen School of Medicine at UCLA, Los Angeles, CA, and Forest Laboratories, Inc. (E.S., S.M.G.), New York, and Department of Psychiatry (P.N.T.), University of Rochester School of Medicine, NY.
Address correspondence and reprint requests to Dr Cummings, Reed Neurological Research Center, UCLA, 710 Westwood Plaza, Suite 2-238, Box 951769, Los Angeles, CA 90095-1769; e-mail: jcummings{at}mednet.ucla.edu
Objective: To investigate the behavioral effects of memantine in moderate to severe Alzheimer disease (AD).
Methods: The authors conducted a hypothesis-generating, exploratory analysis of a 24-week, double-blind, placebo-controlled trial comparing memantine (20 mg/day) with placebo in subjects with moderate to severe AD on stable donepezil treatment. They employed the Neuropsychiatric Inventory (NPI; 12-item), administered at baseline, week 12, and week 24, to assess the effects of memantine on behavior. Global, cognitive, and functional measures were collected and relationships between these assessments and changes in behavior were determined. The intent-to-treat population was examined using last-observation-carried-forward and observed-cases approaches.
Results: Patients treated with memantine had significantly lower NPI total scores than patients treated with placebo. Analyses of the 12 NPI domains revealed significant effects in favor of memantine on agitation/aggression, eating/appetite, and irritability/lability. Of patients who exhibited agitation/aggression at baseline, those treated with memantine showed significant reduction of symptoms compared with placebo-treated patients. Memantine-treated patients without agitation/aggression at baseline evidenced significantly less emergence of this symptom compared with similar patients receiving placebo. Caregivers of patients receiving memantine registered significantly less agitation-related distress. There were significant relationships between the NPI and the global rating scale and performance of activities of daily living, but not between changes in the NPI and cognition.
Conclusion: Treatment with memantine reduced agitation/aggression, irritability, and appetite/eating disturbances. Memantine reduced agitation/aggression in patients who were agitated at baseline and delayed its emergence in those who were free of agitation at baseline.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the July 11 issue to find the title link for this article.
*See the Appendix for a list of Group members.
Supported by a grant from the National Institute on Aging for the UCLA Alzheimer's Disease Research Center (P50 16570), the Alzheimer's Research Center of California, the Sidell-Kagan Foundation, and the Deane F. Johnson Center for Neurotherapeutics.
Disclosure: Dr. Cummings has received personal compensation from Janssen, Forest Laboratories, Inc., Novartis, Pfizer, Eisai, Memory, Lilly, AstraZeneca, Aventis, Ono, Praecis, Bristol Myers-Squibb, Wyeth, Lundbeck, and Neurochem for consulting services. He has also received financial support (for scholarly activities, e.g., research, educations activity, journal club, etc.) for research from Janssen, Forest Laboratories, Inc., Novartis, and SynXPharma. Dr. Tariot has received personal compensation or honoraria from Eisai, Forest Laboratories, Inc., and Janssen, from Pfizer for research support, and from Eisai, Forest Laboratories, Inc., Janssen, Pfizer, and Novartis for consultancies. Drs. Graham and Schneider are employees of Forest Laboratories, Inc.
Received September 16, 2005.
Accepted in final form March 17, 2006.
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