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From Eisai Inc. (Drs. Rogers and Friedhoff), Teaneck, NJ; the Indiana University School of Medicine (Dr. Farlow), Indianapolis, IN; Baylor College of Medicine (Dr. Doody), Houston, TX; and the Mount Sinai Medical Center (Dr. Mohs), New York, NY.
Address correspondence and reprint requests to Dr. L. T. Friedhoff, Eisai Inc., Glenpointe Centre West, 500 Frank W. Burr Blvd., Teaneck, NJ 07666-6741.
The efficacy and safety of donepezil as a treatment for patients with mild to moderate Alzheimer's disease (AD) was investigated in a multicenter, double-blind study. Patients were randomly assigned to treatment with placebo(n = 162), 5 mg/d donepezil (n = 154), or 10 mg/d donepezil (n = 157) for 24 weeks followed by a 6-week, single-blind placebo washout. The primary efficacy measures were the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Clinician's Interview Based Assessment of Change-Plus (CIBIC plus), with the Mini-Mental State Examination (MMSE), Clinical Dementia Rating Scale-Sum of the Boxes (CDR-SB), and patient rated Quality of Life (QoL) used as secondary measures. Cognitive function, as measured by the ADAS-cog, was significantly improved in the 5- and 10-mg/d donepezil groups as compared with the placebo group at weeks 12, 18, and 24. Clinician's global ratings on the CIBIC plus also improved in both the 5- and 10-mg/d donepezil groups relative to placebo. At the end of the 6-week placebo washout phase, ADAS-cog scores and CIBIC plus ratings were not significantly different for the three groups. Significant treatment benefits were also observed consistently in both the 5- and 10-mg/d groups on the MMSE and the CDR-SB, but there was no consistent effect on the patient-rated QoL. Cholinergic side effects (primarily diarrhea, nausea, and vomiting) were reported more often in the 10-mg/d group than either the 5-mg/d or placebo groups. Side effects were transient and generally mild in severity. These data indicate that donepezil is a well-tolerated drug that improves cognition and global function in patients with mild to moderate AD.
*See the Appendix on page 144 for a listing of the members of the Donepezil Group.
Supported by Eisai Inc., Teaneck NJ, U.S.A. and Eisai Co. Ltd., Tokyo, Japan.
Received March 12, 1997. Accepted in final form August 20, 1997.
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G. E. Alexander, K. Chen, P. Pietrini, S. I. Rapoport, and E. M. Reiman Longitudinal PET Evaluation of Cerebral Metabolic Decline in Dementia: A Potential Outcome Measure in Alzheimer's Disease Treatment Studies Am J Psychiatry, May 1, 2002; 159(5): 738 - 745. [Abstract] [Full Text] [PDF]
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A. K. Howard, A. E. Thornton, S. Altman, and W. G. Honer Donepezil for memory dysfunction in schizophrenia J Psychopharmacol, May 1, 2002; 16(3): 267 - 270. [Abstract] [PDF]
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K. Palmer, H.-X. Wang, L. Backman, B. Winblad, and L. Fratiglioni Differential Evolution of Cognitive Impairment in Nondemented Older Persons: Results From the Kungsholmen Project Am J Psychiatry, March 1, 2002; 159(3): 436 - 442. [Abstract] [Full Text] [PDF]
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O L Lopez, J T Becker, S Wisniewski, J Saxton, D I Kaufer, and S T DeKosky Cholinesterase inhibitor treatment alters the natural history of Alzheimer's disease J. Neurol. Neurosurg. Psychiatry, March 1, 2002; 72(3): 310 - 314. [Abstract] [Full Text] [PDF]
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S. Gauthier Advances in the pharmacotherapy of Alzheimer's disease Can. Med. Assoc. J., March 1, 2002; 166(5): 616 - 623. [Full Text] [PDF]
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M. Holden and C. Kelly Use of cholinesterase inhibitors in dementia Adv. Psychiatr. Treat., March 1, 2002; 8(2): 89 - 96. [Full Text] [PDF]
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R. BULLOCK New drugs for Alzheimer's disease and other dementias The British Journal of Psychiatry, February 1, 2002; 180(2): 135 - 139. [Abstract] [Full Text] [PDF]
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J. W. Hill, R. Futterman, S. Duttagupta, V. Mastey, J. R. Lloyd, and H. Fillit Alzheimer's disease and related dementias increase costs of comorbidities in managed Medicare Neurology, January 8, 2002; 58(1): 62 - 70. [Abstract] [Full Text] [PDF]
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G. B. Frisoni, C. Geroldi, A. Beltramello, A. Bianchetti, G. Binetti, G. Bordiga, C. DeCarli, M. P. Laakso, H. Soininen, C. Testa, et al. Radial Width of the Temporal Horn: A Sensitive Measure in Alzheimer Disease AJNR Am. J. Neuroradiol., January 1, 2002; 23(1): 35 - 47. [Abstract] [Full Text] [PDF]
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K Rockwood, J Mintzer, L Truyen, T Wessel, and D Wilkinson Effects of a flexible galantamine dose in Alzheimer's disease: a randomised, controlled trial J. Neurol. Neurosurg. Psychiatry, November 1, 2001; 71(5): 589 - 595. [Abstract] [Full Text] [PDF]
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 J.-I. Iga, M. Araki, Y. Ishimoto, and T. Ohmori A CASE OF KORSAKOFF'S SYNDROME IMPROVED BY HIGH DOSES OF DONEPEZIL Alcohol Alcohol., November 1, 2001; 36(6): 553 - 555. [Abstract] [Full Text] [PDF]
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T. W. Chow and C. H. MacLean Quality Indicators for Dementia in Vulnerable Community-Dwelling and Hospitalized Elders Ann Intern Med, October 16, 2001; 135(8_Part_2): 668 - 676. [Full Text] [PDF]
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S. Nakano, T. Asada, H. Matsuda, M. Uno, and M. Takasaki Donepezil Hydrochloride Preserves Regional Cerebral Blood Flow in Patients with Alzheimer's Disease J. Nucl. Med., October 1, 2001; 42(10): 1441 - 1445. [Abstract] [Full Text] [PDF]
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H. Feldman, S. Gauthier, J. Hecker, B. Vellas, P. Subbiah, and E. Whalen A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease Neurology, August 28, 2001; 57(4): 613 - 620. [Abstract] [Full Text] [PDF]
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I. Litvan, M. Phipps, V. L. Pharr, M. Hallett, J. Grafman, and A. Salazar Randomized placebo-controlled trial of donepezil in patients with progressive supranuclear palsy Neurology, August 14, 2001; 57(3): 467 - 473. [Abstract] [Full Text] [PDF]
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R. C. Mohs, R. S. Doody, J.C. Morris, J. R. Ieni, S. L. Rogers, C. A. Perdomo, and R. D. Pratt A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients Neurology, August 14, 2001; 57(3): 481 - 488. [Abstract] [Full Text] [PDF]
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B. Winblad, K. Engedal, H. Soininen, F. Verhey, G. Waldemar, A. Wimo, A.-L. Wetterholm, R. Zhang, A. Haglund, and P. Subbiah A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD Neurology, August 14, 2001; 57(3): 489 - 495. [Abstract] [Full Text] [PDF]
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J. T O'Brien and C. G Ballard Drugs for Alzheimer's disease BMJ, July 21, 2001; 323(7305): 123 - 124. [Full Text] [PDF]
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R. S. Doody, J.C. Stevens, C. Beck, R.M. Dubinsky, J.A. Kaye, L. Gwyther, R.C. Mohs, L.J. Thal, P.J. Whitehouse, S.T. DeKosky, et al. Practice parameter: Management of dementia (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology Neurology, May 8, 2001; 56(9): 1154 - 1166. [Abstract] [Full Text] [PDF]
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R. S. Doody, D. S. Geldmacher, B. Gordon, C. A. Perdomo, R. D. Pratt, and for the Donepezil Study Group Open-Label, Multicenter, Phase 3 Extension Study of the Safety and Efficacy of Donepezil in Patients With Alzheimer Disease Arch Neurol, March 1, 2001; 58(3): 427 - 433. [Abstract] [Full Text] [PDF]
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