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| |  GSA: Exelon Improves Activities Of Daily Living In Alzheimer’s Patients SAN FRANCISCO, CA -- November 22, 1999 -- Data presented Saturday at the 52nd annual meeting of the Gerontological Society of America suggest that rivastigmine tartrate (Exelon®), an investigational, new generation cholinesterase inhibitor, may be effective in enhancing activities of daily living (ADLs) in patients with mild to moderately severe Alzheimer’s disease. Data were presented by Dr. George T. Grossberg, Director, Division of Geriatric Psychiatry, Saint Louis University School of Medicine, St. Louis, MO, and lead author of the study. Results from a pooled analysis of three phase III double-blind, placebo-controlled studies in patients with mild to moderately severe Alzheimer’s disease found that patients treated with Exelon experienced less decline in ADLs than patients treated with placebo. Approximately 50 percent more patients on Exelon showed a clinically significant improvement (>10 percent) from baseline in ADLs compared to those on placebo. "When an Alzheimer’s patient is unable to perform activities of daily living, such as being able to tell the time and dress themselves, it takes a serious toll on quality of life not only for the patient, but also for the caregiver," said George T. Grossberg, MD. "The results of this study are extremely important as they suggest that treatment with Exelon may improve quality of life for both patients and caregivers. Moreover, contrary to the current assumption, these results demonstrate that patients with moderate and moderately severe AD are able to respond to cholinergic therapy." In this analysis, efficacy was measured by the change from baseline of the PDS (Progressive Deterioration Scale), a commonly used caregiver-rated measure of "quality of life" or ability to perform ADLs such as eating, dressing, completing household chores, etc. In total, the PDS is comprised of 26 individual items designed to give an overall assessment of a patient’s ability to function independently on a day-to-day basis. The study followed patients with mild to moderately severe Alzheimer’s disease who were treated with placebo, low-dose Exelon® (1-4 mg/day) or high-dose Exelon (6-12 mg/day) for 29 weeks. Patients receiving high-dose Exelon were considered clinically improved compared to placebo patients at 18 weeks. In fact, when individual items of the PDS were analyzed, the mean score change from baseline was significantly different for the high-dose Exelon group compared to placebo for every item on the scale. For example, significantly more patients treated with Exelon demonstrated increased abilities to dress appropriately, eat properly, use common household items, walk safely, tell time and show interest in hobbies. Exelon has also shown efficacy in cognition (memory) and global functioning including behavior in phase III clinical trials. The compound is being developed by Novartis Pharmaceuticals and is currently under review with the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease. 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 2 to 4 million adults in the United States, and 10 million worldwide. It has an annual US price tag of approximately $100 billion in direct (healthcare and related) and indirect (income) costs. It is estimated that delaying the onset of the disease by five years could save the nation’s healthcare system as much as $50 billion.
Related Link: Novartis Pharmaceuticals.
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