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| |  DG DISPATCH - ECNP: Donepezil Helps Alzheimer Patients To Function Normally By Olwen Glynn Owen Special to DG News LONDON, UK -- September 27, 1999 -- Results of a one-year study show the anti-dementia therapy, donepezil (Aricept) preserves the ability of patients with Alzheimer’s disease to perform daily living activities for about five months longer than untreated patients.
The prospective, randomised, double-blind, placebo-controlled study was led by Dr Richard Mohs, of Mount Sinai School of Medicine, New York, N.Y. It is the first one-year trial of its type to study effects of an acetylcholinesterase inhibitor on functional status. The results were presented at the 12th congress of the European College of Neuropsychopharmacology, held in London, UK, September 21-25. A total of 431 patients diagnosed with probable Alzheimer’s and capable of performing eight out of 10 daily living activities at baseline were randomised to once-daily treatment with either donepezil 10 milligrams or placebo. Evaluations were performed at six-weekly intervals up to 54 weeks with patients rated on a clinical dementia scale and daily living activity scale. The primary outcome measure was time to reach a pre-specified level of deterioration. At 48 weeks patients receiving donepezil had a 51 percent probability of maintaining their level of function compared to a 35 percent probability for those taking placebo. Life-table and Kaplan-Meier analyses showed that donepezil extended the median time to clinically significant loss of function to four months more than placebo (p<0.01). Commenting on the study, Dr Mohs said the results reinforce data from the one-year Nordic study showing benefits for donepezil on global and cognitive functioning as well as daily living activities. "Our results provide powerful evidence that donepezil is effective in treating symptoms in patients with Alzheimer’s disease." A three-year, open label, safety and tolerability study of donepezil, also presented at the congress by researchers John Leni and colleagues of Eisai Inc., Teaneck, N.J., showed 92 percent of patients experienced adverse events, of which 27 percent were judged to be severe. The most common physical adverse events were urinary tract infections, diarrhoea, headache and nausea. The most common central nervous system effects were agitation, insomnia and depression. However only 17 percent of patients withdrew from treatment because of adverse events. Of 763 patients who started therapy, 76 percent were still taking treatment after one year and 49 percent after two years. Ninety-five percent of patients received 10mg daily.
Related Link: Aricept.
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