Honolulu, Hawaii (April 4, 2003) - New data provide the first evidence that ARICEPT® (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® 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.
A collaboration dedicated to advances in Alzheimer's therapy.
ARICEPT® in MCI
In the first study presented at AAN, researchers found that ARICEPT® treatment improved cognition and was well tolerated in MCI patients. These findings provide preliminary support that the initiation of ARICEPT® may provide benefit in this patient population. The study evaluated the efficacy and tolerability of ARICEPT® 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® in Parkinson's-Related Dementia
A second study presented at AAN found that ARICEPT® reduced behavioral symptoms in patients with dementia related to Parkinson's-disease. The study evaluated the cognitive and neuropsychiatric symptom responses to ARICEPT® 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® (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® 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® in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond.
ARICEPT® 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® may experience fainting. People at risk for ulcers should tell their doctors because their condition may get worse.
ARICEPT® is the number one prescribed Alzheimer's disease therapy worldwide, with more than 1 billion patient days of ARICEPT® therapy sold. More than 1.7 million people in the United States alone have begun ARICEPT® therapy.
ARICEPT® 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®, and for prescribing information on ARICEPT®, please call (888) 999-9616, or visit www.aricept.com. Full prescribing information is available at that Web site.
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 billion in fiscal year 2001 (year ending March 31, 2002). Eisai Inc. employs a total of more than 650 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 2002, Eisai Inc. moved up rapidly in the rankings of U.S. pharmaceutical companies (based on revenues) from No. 44 to 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 products.
Note To Editors:
MCI Study Details
In this 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients were randomized to receive placebo (n=137) or donepezil (n=132, 5 mg/d for first 42 days and 10 mg/d thereafter). Patients were evaluated either as an intent-to-treat (ITT) population or a fully-evaluable (FE) population consisting of patients who had a study medication compliance rate of at least 80 percent at the end of the study.
Both treatment groups had improved Clinician's Global Impression of Change-MCI (CGIC-MCI) scores at endpoint, with no significant difference between ARICEPT® and placebo. Significant differences favoring ARICEPT® were measured by the modified ADAS-cog total score (p<.05). In addition, the FE population benefited significantly from ARICEPT® treatment, according to the following test scores:
- The ARICEPT® group performed significantly better on the ADAS-cog Immediate Word Recall test (p=.034), and there was a tendency toward significance on the Delayed Recall test (p=.053) compared to placebo.
- The NYU Paragraph Intermediate and Delayed Recall test and the Digit Span Backwards test were significantly in favor of the ARICEPT® treatment group compared to placebo (p<.05).
- Significant differences in favor of ARICEPT® were observed in the PGA scores (p=.007) compared to placebo.
Adverse events were reported by 88 percent of the ARICEPT® group and 73 percent of the placebo group, most of which were mild or moderate in severity. Diarrhea, nausea, vomiting, abnormal dreams, insomnia and leg cramps occurred in greater than five percent and twice the rate of placebo.
Parkinson's-Related Dementia Study Details
This was a 12-week open-label study of ARICEPT® involving 10 subjects with Parkinsonian dementia classified as either dementia with Lewy bodies or Parkinson's disease with dementia. The preliminary findings demonstrated:
- Mean improvement in MMSE scores was 1.4 points.
- NPI-Q severity scores decreased on average by 50 percent from baseline (p=0.003), and NPI-Q symptom-related caregiver distress was also significantly decreased (p=0.01).
- In PET-imaged subjects, MMSE change scores were inversely associated with prefrontal AchE activity (p=0.006), and to a lesser extent, activity in orbitofrontal anterior cingulate regions (p=0.03).
Although the results of the two studies provide preliminary support, additional research is ongoing.