A Potential New Treatment For Alzheimer's Disease
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Eisai Medical Research Inc. (Headquarters: New Jersey, President: Mindell Seidlin, MD), a U.S. clinical research subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito), announced today that it will initiate a Phase I clinical trial for E2012, a gamma secretase modulator that is being evaluated as a potential new treatment for Alzheimer's disease. This will be the first clinical trial of E2012 in people. Gamma secretase plays a role in the production of beta-amyloid, a major component of plaque in the brain, which is thought to be a cause of Alzheimer's disease. E2012 is a new chemical entity discovered by Eisai and, in preclinical (laboratory) research, has shown some potential to reduce the production of beta-amyloid by modulating the function of gamma secretase. E2012 and its effect on beta-amyloid will now be evaluated in people. E2012 is part of Eisai's continuing commitment to advancing research regarding Alzheimer's disease and increasing benefits to patients and their families who are facing or will face this disease. As a leader in Alzheimer's disease therapy, in part through its marketed drug, ARICEPT (donepezil hydrochloride tablets), Eisai is pursuing a multi-faceted approach to Alzheimer's disease research that includes investigating genes responsible for the onset of the disease, immunotherapy and vaccine therapy. Information About ARICEPT Treatment in Alzheimer's disease While there is no cure for Alzheimer's disease, medical treatments are available to manage symptoms of the disease. Once-a-day prescription ARICEPT is indicated for mild to moderate Alzheimer's disease. ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and Alzheimer's disease. In a progressively degenerative disease such as Alzheimer's, improvement, stabilization, or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond. ARICEPT is the number one prescribed Alzheimer's disease therapy worldwide, with more than 2.5 billion patient days of ARICEPT therapy. Nearly 2.3 million people in the United States alone have taken ARICEPT. ARICEPT is well tolerated but may not be for everyone. Some people may have nausea, diarrhea, not sleep well or vomit. Some people may have muscle cramps, feel very tired, or may not want to eat. In studies, these side effects were usually mild and went away over time. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting. ARICEPT is co-promoted in the United States by Eisai Inc. and Pfizer Inc, which are dedicated to advances in Alzheimer's therapy. For more information about managing Alzheimer's disease and about ARICEPT, and for prescribing information on ARICEPT, please visit the website http://www.aricept.com/.