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From the Department of Psychiatry (Dr. Tariot), University of Rochester Medical Center, NY; Department of Psychology (Dr. Solomon), Williams College, MA, and the Memory Clinic, Southwestern Vermont Medical Center, Bennington, VT; Department of Neurology (Dr. Morris), Washington University School of Medicine, St. Louis, MO; the Janssen Research Foundation (Drs. Kershaw and Ding), Titusville, NJ; and the Janssen Research Foundation (Dr. Lilienfeld), Beerse, Belgium.
Address correspondence and reprint requests to Dr. Pierre N. Tariot, Department of Psychiatry, Monroe Community Hospital, 435 East Henrietta Road, Rochester, NY 14620.
OBJECTIVE: To investigate the efficacy and tolerability of galantamine, using a slow dose escalation schedule of up to 8 weeks, in 978 patients with mild to moderate AD.
METHODS: A 5-month multicenter, placebo-controlled, double-blind trial. Following a 4-week placebo run-in, patients were randomized to one of four treatment arms: placebo or galantamine escalated to final maintenance doses of 8, 16, or 24 mg/day. Outcome measures included the cognitive subscale of the AD Assessment Scale (ADAS-cog), the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus), the AD Cooperative Study Activities of Daily Living inventory, and the Neuropsychiatric Inventory. Standard safety evaluations and adverse event monitoring were carried out.
RESULTS: After 5 months, the galantamine–placebo differences on ADAS-cog were 3.3 points for the 16 mg/day group and 3.6 points for the 24 mg/day group (p < 0.001 versus placebo, both doses). Compared with placebo, the galantamine 16- and 24-mg/day groups also had a significantly better outcome on CIBIC-plus, activities of daily living, and behavioral symptoms. Treatment discontinuations due to adverse events were low in all galantamine groups (6 to 10%) and comparable with the discontinuation rate in the placebo group (7%). The incidence of adverse events in the galantamine groups, notably gastrointestinal symptoms, was low and most adverse events were mild.
CONCLUSIONS: Galantamine 16 and 24 mg/day significantly benefits the cognitive, functional, and behavioral symptoms of AD as compared with placebo. Slow dose escalation appears to enhance the tolerability of galantamine, minimizing the incidence and severity of adverse events.
Key words: AD—Galantamine—Allosteric modulation—Nicotinic receptors—Acetylcholinesterase inhibition—Randomized controlled trial—Efficacy—Dose escalation—Tolerability.
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J. L. Cummings, A. Nadel, D. Masterman, and P. A. Cyrus Efficacy of Metrifonate in Improving the Psychiatric and Behavioral Disturbances of Patients with Alzheimer's Disease J Geriatr Psychiatry Neurol, June 1, 2001; 14(2): 101 - 108. [Abstract] [PDF]
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R. S. Doody, J.C. Stevens, C. Beck, R.M. Dubinsky, J.A. Kaye, L. Gwyther, R.C. Mohs, L.J. Thal, P.J. Whitehouse, S.T. DeKosky, et al. Practice parameter: Management of dementia (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology Neurology, May 8, 2001; 56(9): 1154 - 1166. [Abstract] [Full Text] [PDF]
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 J. Pearce Review: donepezil, metrifonate, rivastigmine, and Ginkgo biloba are more effective than placebo in Alzheimer's disease Evid. Based Ment. Health, February 1, 2001; 4(1): 24 - 24. [Full Text]
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 J. Pearce Review: donepezil, metrifonate, rivastigmine, and Ginkgo biloba are more effective than placebo in Alzheimer's disease Evid. Based Med., January 1, 2001; 6(1): 14 - 14. [Full Text]
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G. K Wilcock, S. Lilienfeld, and E. Gaens Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial BMJ, December 9, 2000; 321(7274): 1445 - 1445. [Abstract] [Full Text]
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M. A. Raskind, E. R. Peskind, T. Wessel, and W. Yuan Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension Neurology, June 27, 2000; 54(12): 2261 - 2268. [Abstract] [Full Text] [PDF]
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