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Eisai Inc. Release: First Published Prospective Study Of ARICEPT To Demonstrate Significant Treatment Benefits In Patients Exclusively With Early-Stage Alzheimer's Disease


10/19/2005 5:12:27 PM

NEW YORK, Dec. 13 /PRNewswire/ -- . Patients with early (very mild or mild) Alzheimer's disease (AD) who were treated with ARICEPT(R) (donepezil HCl tablets) experienced significant improvements in cognition compared with those taking a placebo. The findings, published today in Archives of Neurology, represent the first prospective study to assess the benefits of ARICEPT treatment exclusively in patients with early-stage AD. Once-a-day prescription ARICEPT is indicated for mild to moderate Alzheimer's disease.

Significant improvements favoring ARICEPT compared to placebo were observed in cognitive function over the 24-week study, measured by the modified Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)/13 items, the primary endpoint of the study. The modified ADAS-cog includes measures such as memory, attention, reasoning, language, orientation and praxis (execution of tasks). A responder analysis showed that cognitive function was stable or improved in approximately 70 percent of study participants who were treated with ARICEPT compared with 47 percent receiving placebo.

Patients in this study had probable AD and were in the early stage of AD as exhibited by mild dementia and mild impairment in activities of daily living.

"This study demonstrates that initiating therapy early in the progression of the disease can help benefit cognitive ability when it is at its highest level. Improving memory and thinking may help patients with activities in their daily lives," said Benjamin Seltzer, M.D., lead author and director of the Alzheimer's Disease & Memory Disorders Center, Tulane University Health Sciences Center, New Orleans.

Dr. Seltzer continued, "Many patients and their families delay seeing a physician about memory problems for several years after symptoms are first noticed. Based on my clinical experience, I encourage seeking a diagnosis of Alzheimer's disease at the earliest sign of disease so that the appropriate treatment can be initiated as soon as possible."

Study Details

This double-blind, randomized, placebo-controlled clinical trial enrolled 153 patients across the United States. Patients, aged 50 to 92 years, were diagnosed with probable AD within the 12 months prior to study initiation with Mini Mental State Examination (MMSE) scores between 21 and 26 (inclusive). ARICEPT group mean MMSE scores were 24.1 (SD = +/- 1.7); placebo group mean MMSE scores were 24.3 (SD = +/- 1.3). Patients were excluded if the decline in memory was possibly due to psychiatric/neurologic disorders. Subjects were randomized in a 2:1 ratio to ARICEPT to 10 mg/d or to placebo. Patients were assessed at screening, baseline and 6-week intervals thereafter through week 24.

ARICEPT-treated patients improved significantly compared to the placebo group on the modified ADAS-cog scale, the primary outcome measure, as early as week 12 (p = 0.025), with significant differences at week 24 (p = 0.008) and at endpoint (p = 0.001). The modified ADAS-cog is an 85-point scale with 13 subtests. Modifications from the original test include the use of the 10-word Delayed Recall and the addition of a Concentration/Distractibility item.

Secondary outcome measures included the MMSE, the Computerized Memory Battery Test (CMBT), the Clinical Dementia Rating Scale-Sum of the Boxes (CDR-SB), the Patient Global Assessment scale (PGA) and the Apathy Scale. Scores from the MMSE, which measures cognitive function and is used to detect impairment and monitor response to treatment, showed significant improvement favoring ARICEPT as early as week 6 (p = 0.017), and were sustained through weeks 24 (p = 0.030) and end point (p = 0.002). Improvement compared with placebo-treated patients was observed on certain CMBT subscales, including Facial Recognition, First and Last Name Total Acquisition, and Name-Face Association Delayed Recall. These tests assess verbal and visual memory. There were no significant differences between the ARICEPT and placebo groups on the CDR-SB scores, Apathy Scale, or PGA scores.

ARICEPT(R) (donepezil HCl tablets) was generally well tolerated in this study. Nearly 16 percent of ARICEPT patients withdrew because of adverse events (AEs) compared with 9 percent in the placebo group. Most adverse events were mild to moderate in severity and transient. The most common medication-related AEs reported in greater than or equal to 5 percent of patients on ARICEPT and at greater than twice the incidence in patients on placebo in the study were diarrhea, abnormal dreams, asthenia and nausea.

Information About ARICEPT(R) (donepezil HCl tablets) 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(R) is indicated for mild to moderate 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(R) in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond.

ARICEPT(R) 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(R) may experience fainting.

ARICEPT(R) is the number one prescribed Alzheimer's disease therapy worldwide, with more than 1 billion patient days of ARICEPT(R) therapy sold. More than 1.7 million people in the United States alone have begun ARICEPT(R) therapy.

ARICEPT(R) 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(R), and for prescribing information on ARICEPT(R), please see accompanying full prescribing information or visit http://www.aricept.com/.

About Eisai Inc.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care company that discovers, develops and markets products in more than 30 countries.

Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1.7 billion in fiscal year ended March 31, 2004.

Eisai Inc. employs a total of more than 1,100 people at its headquarters in Teaneck, N.J., at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, N.C. and in the field. Between 1998 and 2003, Eisai Inc. moved up rapidly in the rankings of U.S. pharmaceutical companies (based on revenues) from No. 44 to No. 20.

About Pfizer Inc

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands.

Eisai Inc.; Pfizer Inc

CONTACT: Judee Shuler of Eisai Inc., +1-201-287-2241; or Alison Lehanskiof Pfizer Inc, +1-212-733-8087; or Becky Lauer of Manning Selvage & Lee,+1-212-468-4125, for Eisai Inc. and Pfizer Inc


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