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Title: Exelon (Rivastigmine) Improves Activities of Daily Living Over Course of Alzheimer's Disease: Presented at AAGP

"Exelon (Rivastigmine) Improves Activities of Daily Living Over Course of Alzheimer's Disease: Presented at AAGP"

ORLANDO, FL -- February 26, 2002 -- Data presented today at the 15th annual meeting of the American Association for Geriatric Psychiatry (AAGP) suggest that treatment with the cholinesterase inhibitor Exelon® (rivastigmine tartrate) may improve activities of daily living (ADLs) in patients with Alzheimer's disease across all stages assessed (mild, moderate, and moderately severe). Researchers looked at results from the three pivotal double-blind, placebo-controlled trials of 2,105 people with Alzheimer's disease. The data were pooled and at 26 weeks patients receiving 6-12 mg/day rivastigmine demonstrated statistically significant improvements when compared to placebo-treated patients in measurements of ADLs, such as the ability to use the telephone or dress themselves, across mild, moderate, and moderately severe disease stages. Exelon is indicated for the treatment of mild-to-moderate Alzheimer's disease. "It's important that we measure the impact of Alzheimer's disease treatment on Activities of Daily Living because that's a good gauge of how Alzheimer's disease adversely affects how people function in practical, real-world settings, and because it is of great concern to patients and their families," said Steven G. Potkin, MD, a psychiatrist from the University of California, Irvine and the study's lead author. "In the study, patients who were treated with rivastigmine consistently showed benefits on activities that were assessed compared to those receiving placebo." Participants were enrolled in one of three trials with rivastigmine and were classified by disease stage using the Global Deterioration Scale (GDS) as mild (GDS less than or equal to three), moderate (GDS equal to four), or moderately severe (GDS greater than or equal to five). The GDS is a tool used to assess the rate and severity of cognitive decline in the elderly -- from deterioration associated with normal aging to severe neurodegenerative dysfunction seen in advanced Alzheimer's disease. ADLs were evaluated using the Progressive Deterioration Scale (PDS), a 29-item, commonly-used caregiver evaluation of the patient's ability to perform common daily tasks. Results were reported for the 6-12 mg/day rivastigmine group in comparison with the placebo group. Researchers found that at week 26, patients treated with rivastigmine showed improvement on overall PDS ratings at all disease stages when compared to placebo-treated patients. Patients taking rivastigmine also showed significant improvements on individual PDS items. For example, among mild stage patients (GDS less than or equal 3), differences in dialing telephone numbers, telling time, and ability to travel alone were statistically significant between rivastigmine and placebo. At the moderate stage, differences were statistically significant when it came to dressing properly, driving safely, and participating in family finances. At the moderately severe stage, the differences were statistically significant when it came to ability to use the telephone, eating manners, and rearranging objects. Alzheimer's disease is a neurodegenerative disease involving deterioration of the brain. It is the fourth leading cause of death behind cardiovascular disease, cancer, and stroke and affects up to four million adults in the United States, and more than 10 million worldwide. It has an annual U.S. price tag of approximately $100 billion in direct (healthcare and related) and indirect (income) costs. Although there is currently no cure, medications, such as Exelon, are available for people with mild-to-moderate Alzheimer's disease that can help maintain levels of an important chemical in the brain, thereby enabling the brain to function better. SOURCE: Novartis Pharmaceuticals Corporation

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