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| |  ECNP: Aricept Effective Therapy For Alzheimer’s LONDON, UK -- September 22, 1999 -- Aricept® (donepezil HCl) significantly extends the functional ability of patients with mild to moderate Alzheimer’s disease, according to new one-year data presented today at the 12th European College of Neuropsychopharmacology (ECNP) Congress, in London, UK. Aricept is a clinically proven, once-a-day prescription medication that is indicated for symptomatic treatment of mild to moderately severe Alzheimer’s dementia. Results of this study confirm that treatment with the medication for up to one year allows patients to maintain their ability to perform activities of daily living such as dressing, eating meals, doing chores and enjoying hobbies, and therefore helps them maintain their independence. "This is the first U.S. study of acetylcholinesterase inhibitors to evaluate the effects of one years' therapy in patients with Alzheimer’s disease," said Richard Mohs, Ph.D., professor, department of psychiatry, Mount Sinai School of Medicine and the study’s lead investigator. "These findings suggest that prolonged treatment with Aricept (donepezil HCl) is an important weapon to improve or maintain patients’ independence while living with the disease." During the double-blind, placebo-controlled study, researchers evaluated the time to reach clinically significant decline in function in patients with Alzheimer’s disease taking Aricept compared to placebo. Patients who met predetermined criteria for clinically significant decline in function were discontinued from the study. These criteria included a decline in the patient’s ability to perform one or more basic activities of daily living; a reduction of 20 percent in ability to perform one or more instrumental activities of daily living, such as preparing meals and using household appliances; or a one-point increase in the global Clinical Dementia Rating, a clinically validated measure of disease severity. Of the 431 patients, 214 took 10-mg of Aricept® once daily, and the other 217 participants took placebo. Assessments of patient function were conducted at baseline and at six-week intervals for 54 weeks. At 48 weeks, patients taking Aricept® had a 51 percent probability of maintaining function compared to a 35 percent probability for those on placebo. In addition, patients on Aricept® maintained their functional ability for about five months longer (median time) than those on placebo. This means that Aricept®-treated patients showed a 62 percent chance of maintaining their functional ability over that of patients on placebo in this one-year study. "The study shows that time to functional loss is delayed in patients who are treated with Aricept®," Dr. Mohs added. "Our results complement an earlier one-year European trial and provide powerful evidence that Aricept® is effective in treating symptoms in patients with Alzheimer’s disease." The new findings reinforce data from the one-year Nordic Study presented at the Ninth Congress of the International Psychogeriatric Association in August. Results of that randomized, double-blind, placebo-controlled trial demonstrated that Aricept (donepezil HCl) had beneficial effects on global and cognitive functioning and activities of daily living of study patients treated for one year. These are the first one-year placebo-controlled trials in Alzheimer’s disease with a cholinesterase inhibitor. Alzheimer’s disease is a progressive, degenerative brain disorder that results in impaired memory and thinking, behavior changes, and loss of language and motor skills. Currently, approximately 15 million people suffer from the disorder worldwide. Aricept is indicated for symptomatic treatment of mild to moderately severe Alzheimer’s dementia. It is well-tolerated, with a low incidence of side effects, offers convenient once-daily dosing and can be taken with or without food. In controlled trials that supported the drug’s U.S. Food and Drug Administration marketing approval, it was found that the most common side effects include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue and anorexia. These effects were often mild, transient and resolved with continued treatment. People at risk for ulcers should inform their doctor when taking Aricept. In pivotal clinical trials, syncopal episodes have been reported in patients taking Aricept (2 percent vs. 1 percent for placebo). Aricept is clinically effective at the starting dose of 5-mg/day and the dose can be escalated to 10-mg/day after four to six weeks if clinically indicated.
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