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 ®
- 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
- 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 ® 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 ®
- 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
- 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
- Aricept ® produces statistically significant improvements in
cognitive function versus placebo -- approximately 3 points as
measured by ADAS-cog (a clinically validated measure of cognitive
- Aricept ® has a simple dosing regimen -- it is the only once-a-day
prescription Alzheimer's therapy and can be taken with or without
- 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
- 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
Response Fact Sheet References
1. NDC Health Information Services, Patient Tracking Analysis, January
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.
3. Rogers SL, Doody RS, Mohs RC, Friedhoff LT, and the Donepezil Study
Group. Donepezil improves cognition and global function in
a 15-week double-blind, placebo-controlled study. Arch Intern Med.
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.
11. Winblad B, Engedal K, Soininen H, et al. Donepezil enhances global
function, cognition, and activities of daily living compared to
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.
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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