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Long-Term Outcomes of Galantamine Treatment in Patients With Alzheimer Disease

Received February 17, 2003; revised May 29, November 10, 2003; accepted February 4, 2004. From the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (CGL), UMDNJ-New Jersey Medical School, Newark, NJ (WER), and Janssen Pharmaceutica Products, L.P., Titusville, NJ (PK,YZ). Send correspondence to Constantine G. Lyketsos, M.D., M.H.S., Professor of Psychiatry, Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Osler 320, 600 North Wolfe Street, Baltimore, MD 21287. e-mail: kostas{at}jhmi.edu
© 2004 American Association for Geriatric Psychiatry

Objective: The authors evaluated the long-term safety, efficacy, and tolerability of galantamine 24 mg/day in the treatment of Alzheimer disease by means of a 12-month, open-label extension of an earlier 5-month, double-blind, placebo-controlled trial with a 6-week withdrawal phase. Methods: Patients completing two double-blind, placebo-controlled trials (N=699) were escalated to a 24-mg dose (12 mg bid) of galantamine during a period of 2 weeks and treated for 12 months beyond the initial 6.5-month, double-blind period (total treatment duration: 18.5 months). The primary efficacy measure was the change from baseline in the Alzheimer's Disease Assessment Scale (ADAS-Cog/11) score at 18.5 months; secondary endpoints included total scores on the Alzheimer's Disease Cooperative Study of Activities of Daily Living and the Neuropsychiatric Inventory. Standard safety evaluations, including adverse-event monitoring, were performed. Results: Patients taking galantamine continuously throughout the double-blind and open-label studies (N=288) showed sustained cognitive benefits on ADAS-Cog/11 scores at 18.5 months. Patients were maintained close to baseline cognitive ability for 12 months, and safety was as expected and documented in other large studies of galantamine. Analysis of the subgroup of patients (N=113) who completed the entire 18.5 months of galantamine treatment showed that cognitive function was maintained up to 14 months. Conclusions: Results of this open-label extension support the findings from previous galantamine studies and demonstrate the safety and tolerability of galantamine for up to 18.5 months.

Key Words: Alzheimer Disease • Cognitive Impairment • Dementia • Galantamine • Acetylcholinesterase Inhibitors

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