Investigational Alzheimer's Drug Improves Memory Up to One Year

Author: Pierre Tariot, Tom Wessel
Date: August 15, 2000

(6th International Springfield Symposium) According to the results of two studies, patients receiving galantamine (an investigational drug under review by the U.S. Food and Drug Administration for the treatment of Alzheimer's disease) improved in memory, behavior and ability to perform activities of daily living (ADL), and were able to sustain these cognitive and functional benefits for up to 12 months. The first study was a five-month, double-blind, placebo-controlled trial involving 978 patients with mild to moderate Alzheimer's disease. Patients were randomized to one of four treatment groups, including a placebo group and three groups who received daily dosages of galantamine (8, 16 and 24 mg, respectively). The researchers used a variety of measures to assess the efficacy of the treatment, including the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog); the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus); the version of the Alzheimer's Disease Cooperative Study Inventory that includes ADL; and the Neuropsychiatric Inventory. Overall, the patients who received 16 mg of galantamine scored higher on each efficacy measure than patients who received placebo. The scores that measure cognition and the frequency and severity of behavioral symptoms were improved in patients in the galantamine groups at the completion of the study, compared with the patients' scores at the beginning of the trial. In contrast, the scores of patients in the placebo group had worsened. In patients receiving 16- and 24-mg dosages of galantamine, there was virtually no change in the ability to perform ADL from the start of the trial, whereas ADL deteriorated among the patients who received placebo. Adverse effects were mainly gastrointestinal, transient and mild to moderate in intensity. The second study demonstrated that patients receiving galantamine were able to maintain or increase their levels of cognitive performance and ability to participate in ADL after one year of treatment. A total of 636 patients were randomized into three groups, receiving placebo or a maximum daily dosage of galantamine of 24 or 32 mg. Eighty-one percent of the patients who completed the first six months of the study continued treatment with an open-label, daily dosage of 24 mg of galantamine for an additional six months. Primary assessment tools included the ADAS-cog and CIBIC-plus scales. Side effects were similar to side effects in the five-month trial.--PIERRE TARIOT, M.D., ET AL., University of Rochester Medical Center, New York City; TOM WESSEL, M.D., ET AL., Janssen Research Foundation.

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