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Two New Studies Show Benefit of Donepezil in Mild Cognitive Impairment, Parkinson's-related Dementia

HONOLULU, April 4 /PRNewswire/ -- New data provide the first evidence that ARICEPT(R) (donepezil HCl tablets) may have potential in treating two dementia-related illnesses beyond Alzheimer's disease (AD). Findings from two separate studies showed that treatment improved cognition in patients with mild cognitive impairment (MCI) and behavioral symptoms in patients with Parkinson's-related dementia. The data were presented for the first time at the American Academy of Neurology 55th Annual Meeting (AAN). ARICEPT(R) is approved for the treatment of symptoms of mild to moderate Alzheimer's disease.

"As the first placebo-controlled trial with an acetylcholinesterase inhibitor to improve cognitive symptoms in MCI, this study provides encouraging news for the millions of Americans with MCI," said Stephen Salloway, M.D., director of Neurology and The Memory Disorders Program, associate professor of Clinical Neurosciences at Brown Medical School, Providence, Rhode Island. "The findings underscore the importance of early intervention to promote healthy aging and preserve independence in the elderly."

Experts estimate that dementia affects between four and five million Americans. MCI primarily affects memory, although other areas can be affected, such as language and attention, and is not associated with normal aging. MCI is often a warning sign of the start of AD and other dementias. In fact, over the course of a year, about 10-15 percent of those with MCI will develop AD.

ARICEPT(R) in MCI
In the first study presented at AAN, researchers found that ARICEPT(R) treatment improved cognition and was well tolerated in MCI patients. These findings provide preliminary support that the initiation of ARICEPT(R) may provide benefit in this patient population. The study evaluated the efficacy and tolerability of ARICEPT(R) in patients with MCI, who had a global Clinical Dementia Rating of 0.5 (memory box score of 0.5 or 1.0) and Mini-Mental State Examination score of no less than 24.

The primary outcome measures for this study were the Clinician's Global Impression of Change-MCI (CGIC-MCI) and New York University (NYU) Paragraph test. Secondary endpoint measures were modified Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Digit Span Backwards test, Symbol Digit Modalities test and Patient Global Assessment (PGA).

ARICEPT(R) in Parkinson's-Related Dementia
A second study presented at AAN found that ARICEPT(R) reduced behavioral symptoms in patients with dementia related to Parkinson's-disease. The study evaluated the cognitive and neuropsychiatric symptom responses to ARICEPT(R) treatment in Parkinson's-related dementia. Primary outcome measures were assessed by the paired t-test (12-week vs. baseline) and included the Mini-Mental State Exam (MMSE) (MMSE, mean baseline 22.2) and Neuropsychiatric Inventory-Questionnaire (NPI-Q, mean baseline 5.9). The authors compared baseline acetylcholinesterase (AChE) activity using PET imaging. Results showed that patients with lower baseline AChE activity in the prefrontal and frontal-limbic regions of the brain were associated with greater cognitive responses to treatment.

Information About ARICEPT(R) (donepezil HCI 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 experience nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, or loss of appetite. In studies, these side effects were usually mild and temporary. Some people taking ARICEPT(R) may experience fainting. People at risk for ulcers should tell their doctors because their condition may get worse.

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 dementia therapy.

For more information about managing Alzheimer's disease and about ARICEPT(R), and for prescribing information on ARICEPT(R), please call (888) 999-9616, or visit www.aricept.com. Full prescribing information is available at that Web site.

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