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New Therapy, Support Services For Alzheimer's Disease NEW YORK, Feb. 26, 1997 -- Recent therapeutic developments, combined with an enhanced understanding of the family's critical role in caregiving, add up to a meaningful difference in the lives of those affected by Alzheimer's disease. A new drug that, in controlled clinical trials, has been shown to be safe and effective in enhancing cognition and improving patient function* in people with mild to moderate Alzheimer's disease, is now available by prescription at pharmacies nationwide. Aricept(TM) (donepezil hydrochloride) tablets, or E2020, was discovered by Eisai Co., Ltd. of Tokyo, developed by Eisai America, Inc. and co-promoted by Eisai, Inc. and Pfizer Inc (NYSE: PSE), Aricept(TM) was cleared for marketing by the U.S. Food and Drug Administration on November 25, 1996. Another product, TriAD(TM) is a new disease management program and is the first and only comprehensive program addressing the needs of the clinician, the patient and the caregiver. The program is available at no cost to anyone with Alzheimer's disease, regardless of their treatment regimen. The TriAD(TM) program was developed by Eisai, Inc. and Pfizer Inc with the collaboration of the Alzheimer's Association and the National Council on the Aging. TriAD(TM) was developed in association with an independent advisory board comprised of clinicians who are Alzheimer's disease experts with varied research and practice perspectives. The TriAD(TM) program encompasses educational materials, diagnostic and assessment tools for the physician and treatment guidelines and systems for monitoring patient progress. Support materials for the caregiver and patient include an educational video and booklet and a series of periodic newsletters called Adaptations for Living(TM). "I believe that TriAD(TM) is a truly unique and beneficial program from both a medical standpoint and from a quality of life perspective. It creates a meaningful opportunity for partnership among the patient, caregiver and physician and gives families a practical way to help manage their loved ones' condition," said Jeffrey L. Cummings, M.D., a member of the TriAD(TM) advisory board and a neurologist at the University of California, Los Angeles. An integral component of the program is the TriAD(TM) Helpline (1-888-874-2343), a toll-free number which uses a triage system to direct callers to a variety of Alzheimer's disease resources including community services, legal and financial information. Some of the information distributed by the TriAD(TM) Helpline will be provided by the NCOA (an association of more than 7,500 organizations and individuals who work with, for and on behalf of older persons) and the Alzheimer's Association (the only national voluntary health organization dedicated to Alzheimer's disease research and to providing assistance and support to affected families). About Aricept(TM) (donepezil hydrochloride) Tablets Controlled clinical trials in over 900 patients demonstrated that more than 80 percent of patients taking Aricept(TM) experienced improvement in cognition or exhibited no further decline in tests of cognition over the course of the studies, lasting up to six months. In an assessment of patient function*, which includes general function, cognition, behavior and activities of daily living, clinicians rated approximately two times as many patients on Aricept(TM) as clinically improved in comparison to patients on placebo after 24 weeks of treatment in a 30 week study. David S. Geldmacher, M.D., clinical director of the Alzheimer Center at the University Hospitals of Cleveland and Case Western Reserve University and an Aricept(TM) clinical investigator said, "Although we cannot yet cure the disease, Aricept(TM) provides the Alzheimer community with a safe and effective means to combat the symptoms in mild to moderate Alzheimer patients. Because of the progressive nature of this disease, we can be encouraged by Aricept(TM) patients who do not decline in cognition or daily function while on drug therapy." Aricept(TM) is a reversible inhibitor of the enzyme acetylcholinesterase, which breaks down the neurotransmitter acetylcholine. Acetylcholine, thought to be associated with memory and learning, is in shortsupply in patients with Alzheimer's disease. Aricept(TM) therapy may result in a higher concentration of acetylcholine in the brain, thereby improving cognitive function. Approximately 83 percent of patients enrolled in Aricept(TM) (donepezil hydrochloride) tablets controlled clinical trials completed their scheduled participation. Aricept(TM) was well-tolerated** in these trials. The most common side effects include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue and anorexia. In clinical studies with Aricept(TM), these effects were often mild, and generally went away with continued treatment. Furthermore, liver function monitoring is not required. Aricept(TM) is given once-daily and is available by prescription in 5 mg and 10 mg tablets and is priced approximately 16 percent lower than the only other product available for the treatment of Alzheimer's disease. The once-daily 5 mg dose has been shown to be clinically effective. Some patients might receive additional benefit from the 10 mg once-daily dose after four to six weeks of 5 mg once-daily therapy. * The Clinician's Interview-Based Impression of Change plus Caregiver Assessment (CIBIC plus) is a semi-structured, subjective instrument intended to examine four major areas of patient function: general, cognitive, behavioral and activities of daily living. It represents the assessment of an independent clinician based on an interview with the patient and caregiver. This instrument has not been systematically compared to other global methods or to assessments that do not use information from caregivers. ** Although no increase in peptic ulcer disease or gastrointestinal bleeding was observed in clinical studies of Aricept(TM), patients should be carefully observed for signs of gastrointestinal bleeding, especially those at increased risk for developing ulcers. In clinical studies, two percent of patients treated with Aricept(TM) experienced fainting. E-mail this page to a friend or colleague! To print, use this version