Aricept(reg) - Benefits for African Americans with Alzheimer's Disease

Main Category: Alzheimer's / Dementia
Article Date: 18 Apr 2005 - 0:00 PDT

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First Study of Aricept(reg) Exclusively in African American Patients With Mild to Moderate Alzheimer's Disease Suggests Benefits of Treatment in This Population.

Alzheimer's Incidence Up to Three Times Higher in African Americans; Patients Tend to Go Longer Without Diagnosis.

African American patients with mild to moderate Alzheimer's disease (AD) treated with ARICEPT(reg) (donepezil HCl tablets) experienced significant improvements in cognition and global function from baseline, according to a study presented at the 57th annual meeting of the American Academy of Neurology. Global function is defined as the overall assessment of behavior, activities of daily living and cognition. This open-label study evaluated 126 African American patients taking ARICEPT for 12 weeks.

The incidence of Alzheimer's disease has been reported to be two to three times higher in African Americans than in Caucasians. Yet, African Americans tend to be diagnosed during a later stage of AD, when cognitive function has already substantially declined. While African American patients have participated in previous ARICEPT clinical trials, the Treatment of Alzheimer's in African American Patients (TAAAP) study was the first clinical trial to assess the benefit of ARICEPT treatment exclusively in this population.

"These findings are important because they suggest the benefits of treatment with ARICEPT in African American patients with mild to moderate Alzheimer's disease," said Patrick Griffith, M.D., the study's lead investigator and professor of clinical medicine (Neurology) at Morehouse School of Medicine in Atlanta. "This should serve as a call to action for African American patients, caregivers and their physicians to watch for early signs of Alzheimer's disease symptoms, such as memory loss, and intervene with treatment."

The Mini-Mental State Examination (MMSE) score, which measures cognitive function, significantly improved from baseline (p<0.0001). The Clinician's Interview-Based Impression of Change (CIBIC-plus) also improved when compared at each visit (p<0.0001). About 72 percent of patients taking ARICEPT improved on this measure and 16 percent were stable at endpoint. The CIBIC-plus measures overall global function, including cognition, activities of daily living and behavior, based on interviews with the patient and caregiver. The Fuld Object Memory Evaluation (FOME), which assesses learning and memory among patients with various educational levels and cultural backgrounds through common object recognition, also showed significant improvement with ARICEPT (p<0.0001). The most common adverse events greater than or equal to five percent were diarrhea (6 percent), hypertension (6 percent) and urinary tract infection (5 percent). Approximately five percent of patients discontinued their participation in the study due to adverse events.

The number of African Americans aged 65 and older will more than double by 2030, and is estimated to reach 6.9 million. Increasing age is a risk factor for Alzheimer's disease.

Additional Study Details

This clinical trial enrolled African-American patients at 26 centers across the United States. Patients were at least 50 years of age and had a diagnosis of AD as classified by the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV) and a MMSE score of 10-26. After up to four weeks of screening period and a 1-week baseline period, patients were given open-label ARICEPT(reg) (donepezil HCl tablets), 5 mg/day, then increased to 10 mg/day after 4 weeks at the discretion of the investigator. Measurements were taken at baseline and at 4-week intervals until week 12.

Information About ARICEPT(reg) (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 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 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 the number one prescribed Alzheimer's disease therapy worldwide, with more than 1 billion patient days of ARICEPT therapy. 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 Alzheimer's therapy.

For full ARICEPT prescribing information, please call (888) 999-9616 or visit www.aricept.com/pi/aricept_pi.htm.

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.

http://www.eisai.com

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