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Aricept ® (Donepezil Hydrochloride) For The Treatment Of Mild-To-Moderate Alzheimer's Disease



  • Aricept ® is the #1 prescribed Alzheimer's medication worldwide with more than 450 million days of patient use; more than 1.4 million people in the United States alone have begun Aricept ® therapy.(1)

  • Aricept ® has been proven to enhance cognition and maintain patient function with consistent statistically significant efficacy observed in clinical trials of patients with mild-to-moderate Alzheimer's disease.(2)

  • Aricept ® has demonstrated significant efficacy in global function versus placebo using a global measure that examines cognitive function, behavioral disturbances, activities of daily living, and general function. ~(2)(3)(4)(5)

  • In one study of moderate-stage patients (MMSE 10-17), Aricept ® demonstrated statistically significant improvement versus placebo for the total Neuropsychiatric Inventory (NPI) score,(*5)as well as for delusions, apathy, and aberrant motor behavior (eg, wandering). In addition, improvement in all behavioral symptom items favored Aricept ®.(6)

  • Aricept ® is the only Alzheimer's disease prescription drug in the cholinesterase inhibitor class with 2 one-year placebo-controlled trials that showed that Aricept ® maintained cognitive function and preserved patient function for up to one year.(7)

  • In a 1-year U.S. study, patients treated with Aricept ® maintained function significantly longer (median time about 5 months, or 72% longer) than those treated with placebo.(8)(9)

  • In a multinational 1-year study, cognition was maintained or improved in nearly half of patients treated with Aricept ® (donepezil hydrochloride).(11)

  • In studies in animals, cholinesterase inhibitors, including Aricept ®, were associated with an up-regulation (increase in the number) of nicotinic receptors. (12)(13)(14)The clinical significance of this additional activity is not currently known, but is being studied.

  • Aricept ® has 7 years of experience in Alzheimer's disease clinical trials with more than 6,200 patients participating worldwide.(6) Patients in some clinical trials have been followed for more than 4 years. [Study 202]

  • In one study of 286 Alzheimer's disease patients and their caregivers, caregivers of Aricept ®-treated patients reported spending less time on average per day (9.9 hours per day) providing care than caregivers of placebo-treated patients (11.0 hours per day).(15)

  • In results from a self-administered survey, caregivers of Alzheimer's disease patients treated with Aricept ® reported less difficulty with caregiving than caregivers of Alzheimer's disease patients not treated with Aricept ®.(16)

  • Aricept ® labeling does not require monitoring of liver or kidney function.(17)

  • Aricept ® produces statistically significant improvements in cognitive function versus placebo -- approximately 3 points as measured by ADAS-cog (a clinically validated measure of cognitive function).(17)

  • Aricept ® has a simple dosing regimen -- it is the only once-a-day prescription Alzheimer's therapy and can be taken with or without food.(17)

  • Aricept ® is the only Alzheimer's prescription therapy available that offers efficacy with the starting dosage strength. It does not require titration to reach an effective dose.(17)

  • Other available prescription Alzheimer's medications are on a twice-a-day dosing schedule and require additional weeks of titration to reach an effective dose.(18)(19)

  • The approved product labeling for Aricept ® (donepezil hydrochloride) does not include any bolded or boxed warnings or any precautions directed specifically to caregivers or patients.(17)

  • 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.(17)

  • In a progressively degenerative disease such as Alzheimer's, favorable responses include improvement, no further decline or a less than expected decline. Improvement, stabilization, and decline have been observed in patients treated with Aricept ® in clinical trials. Individual responses to treatment may vary.(2)

~ CIBIC plus is the Clinician's Interview-Based Impression of Change plus Caregiver Assessment. It is a semi-structured, subjective instrument that was intended to examine 4 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.(5)

* NPI is a 12-item scale which measures behavioral disturbances commonly occurring in dementia patients. The frequency and severity of symptoms in each domain are determined through scripted questions answered by the patient's caregiver. Higher scores indicate more severe behavioral problems.(10)

Response Fact Sheet References

  • 1. NDC Health Information Services, Patient Tracking Analysis, January 1997-September 2000.
  • 2. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT, and the Donepezil Study Group. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology. 1998;50:136-145.
  • 3. Rogers SL, Doody RS, Mohs RC, Friedhoff LT, and the Donepezil Study Group. Donepezil improves cognition and global function in Alzheimer's disease: a 15-week double-blind, placebo-controlled study. Arch Intern Med. 1998;158:1021-1031.
  • 4. Burns A, Rossor M, Hecker J, et al. The effects of donepezil in Alzheimer's disease -- results from a multinational trial. Dement Geriatr Cogn Disord. 1999;10:237-244.
  • 5. POA 1, 2001, page 2-5 (for approved language only).
  • 6. Feldman H, Gauthier S, Hecker J, Vellas B, Subbiah P, Whalen E. MSAD - Donepezil provides benefits in global function in moderate to severe Alzheimer's disease. Eur J Neurol 2000;7(suppl):133(P3112).
  • 7. Data on File, Eisai Inc., Teaneck, NJ.
  • 8. Mohs R, Doody R, Morris J, et al. Donepezil preserves functional status in Alzheimer's disease patients: results from a 1-year prospective, placebo-controlled study. Eur Neuropsychopharm. 1999;9(suppl 5):S328.
  • 9. POA 1, 2001, page 6 (for approved language only).
  • 10. Cummings JL, Mega M, Gray K, et al. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994;44:2308-2313.
  • 11. Winblad B, Engedal K, Soininen H, et al. Donepezil enhances global function, cognition, and activities of daily living compared to placebo in a one year, double-blind trial in patients with mild to moderate Alzheimer's disease. Int Psychogeriatr. 1999;11(suppl 1):138.
  • 12. Barnes C, Meltzer J, Houston C, et al. Chronic treatment of old rats with donepezil or galantamine: effects on memory, hippocampal plasticity and nicotinic receptors. Neuroscience. 2000;99:17-23.
  • 13. Hellstrom-Lindahl E, Moore H, Nordberg A. Increased levels of tau protein in SH-SY5Y cells after treatment with cholinesterase inhibitors and nicotinic agonists. J Neurochem. 2000;74:777-784.
  • 14. Svensson A-L, Nordberg A. Interaction of tacrine, galanthamine, NXX- 066 and E2020 with neuronal alpha4beta2 nicotinic receptors expressed in fibroblast cells, in Alzheimer's Disease: Biology, Diagnosis and Therapeutics (Iqbat K, Winblad B, Nishimura T, Taked M, and Wisniewski HM, eds) pp 753-758, John Wiley & Sons, New York.
  • 15. Mastey V, Wimo A, Winblad B, et al. Donepezil reduces the time caregivers spend providing care: results of a one-year, double-blind, randomized trial in patients with mild to moderate Alzheimer's disease. Accepted for presentation at 14th annual meeting of the American Association for Geriatric Psychiatry, February 24-26, 2000, San Francisco, CA.
  • 16. Fillit H, Gutterman E, Brooks R. Impact of donepezil on caregiving burden for patients with Alzheimer's disease. Int Psychogeriatr. 2000;12:389-401.
  • 17. ARICEPT(R) Product Labeling, Eisai Inc., Teaneck, NJ.
  • 18. Cognex(R) Product Labeling, Parke-Davis, Morris Plains, NJ.
  • 19. Exelon(R) Product Labeling, Novartis, East Hanover, NJ.

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