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| |  Exelon Shown To Be Effective In Alzheimer’s Patients EAST HANOVER, NJ -- July 27, 1998 -- According to new research published in the current issue of the International Journal of Geriatric Psychopharmacology, a robust effect on cognitive function was reported in Phase III trials with Alzheimer's disease patients taking Novartis Pharmaceuticals Corp.’s Exelon(R) (rivastigmine tartrate). Exelon is a new, potent, brain-selective acetylcholinesterase inhibitor (AChEI) currently under review at the United States Food and Drug Administration. The published results of this 26-week placebo-controlled study involving nearly 700 participants show that more than half (56 percent) of patients treated with 6 to 12 mg/day of Exelon showed either improvement or stabilisation in their cognitive function at the completion of the trial, according to the Alzheimer's Disease Assessment Scale-Cognitive sub-scale (ADAS-Cog), a common cognitive measurement scale. In contrast, the majority of patients receiving placebo experienced the progressive deterioration in cognitive abilities generally observed in mild to moderately severe Alzheimer's disease. "The results of this trial are highly encouraging and provide strong evidence that cholinesterase inhibitors like rivastigmine tartrate can be effective in improving symptoms in some and stabilising or slowing the rate of decline in other patients with Alzheimer's disease," said Jody Corey-Bloom, M.D., Ph.D., associate professor of neurosciences at the University of California, San Diego and lead investigator for the study. "It is particularly striking that evidence of treatment efficacy for Exelon was demonstrated in all three areas -- cognition, behaviour and activities of daily living -- used to assess the disease and was evaluated by three independent parties highly qualified to appraise a patient's progress -- the psychologist, clinician and caregiver. " The study findings also confirm that many patients treated with Exelon maintained and in some cases improved, their activities of daily living. These patients were better able to perform both simple and complex activities of daily living, such as dressing independently and travelling without getting lost, as measured by the PDS scale, a caregiver rated measure of activities of daily living. Alzheimer's disease is a neurodegenerative disease involving deterioration of the brain. Memory loss and the inability to perform daily activities are hallmarks of this fatal disease. Alzheimer's disease, the fourth leading cause of death behind cardiovascular disease, cancer and stroke, affects three to four million adults in the U.S. and 10 million world-wide. Exelon belongs to the class of drugs known as acetylcholinesterase inhibitors (AChEIs). Acetylcholine is a neurotransmitter that is thought to play an important role in memory and cognition and scientists have learned that levels of acetylcholine are dramatically lower in people with Alzheimer's disease. AChEIs inhibit cholinesterase, an enzyme that normally breaks down acetylcholine. Thus, more of the crucial neurotransmitter acetylcholine is available for normal memory-related and cognitive functioning. The most common side effects seen with Exelon are consistent with this class of drugs and include nausea, vomiting, dyspepsia, anorexia and asthenia, which were transient, occurred most frequently during the titration period and were generally mild to moderate in intensity. Novartis filed a new drug application for Exelon with the FDA on April 7, 1997. The FDA recently requested additional analyses of the Exelon data before an approval of the application is granted. Exelon has been cleared for marketing in over 30 countries to date, including all 15 member states of the European Union, New Zealand, Argentina and Mexico.
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