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Galantamine Treatment of Problematic Behavior in Alzheimer Disease

Post-Hoc Analysis of Pooled Data From Three Large Trials

Received March 4, 2004; revised May 5, May 28, 2004; accepted June 2, 2004. From Sunnybrook and Women’s College Health Sciences Centre and University of Toronto, Toronto, Ontario, Canada (NH), Regional Mental Health Care and University of Western Ontario, London, Ontario, Canada (KR), Covar, Inc., Mississauga, Ontario, Canada JW), and Janssen-Ortho, Inc., Toronto, Ontario, Canada (CB). Send correspondence and reprint requests to Nathan Herrmann, M.D., Dept. of Psychiatry, Sunnybrook and Women’s College Health Sciences Centre, Toronto, Ontario, CANADA, M4N 3M5. e-mail: Nathan.Herrmann{at}sw.ca
© 2005 American Association for Geriatric Psychiatry

Objective: The authors explored the effect of galantamine on behavioral symptoms in Alzheimer disease (AD). Methods: Data were pooled from 2,033 subjects with mild-to-moderate AD who had participated in one of three randomized, double-blind, placebo-controlled trials of 3-, 5-, and 6-month durations. Subjects included in this post hoc analysis had received treatment with either placebo (N=686) or galantamine (N=1347) in total daily doses of 16 mg, 24 mg, or 32 mg. Behavioral symptoms were measured on the 10-item Neuropsychiatric Inventory (NPI). Four symptom clusters were defined a priori: 1) delusions, hallucinations; 2) agitation, depression, anxiety, apathy, irritability; 3) disinhibition, elation, aberrant motor behavior; 4) hallucinations, anxiety, apathy, aberrant motor behavior. Results: At endpoint, mean changes from baseline in NPI scores were significantly different between galantamine-treated subjects and placebo-treated subjects, favoring galantamine for several measures: total NPI, individual domains of agitation/aggression, anxiety, disinhibition, and aberrant motor behavior, and Clusters 1, 3, and 4. The magnitude of the effect sizes was small. Conclusions: In this pooled sample of more than 2,000 subjects with mild-to-moderate AD, those who received galantamine therapy experienced modestly better, but statistically significant, outcomes in their behavioral symptoms than placebo-treated subjects. The cluster of hallucinations, anxiety, apathy and aberrant motor behaviors may represent a specific group of cholinergic-responsive behavioral symptoms.

Key Words: Alzheimer Disease • Behavioral Problems • Cholinesterase Inhibitors • Galantamine

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