Efficacy of donepezil in mild cognitive impairment: A randomized placebo-controlled trial

Neurology

Volumn 63, Issue 4, 2004, Pages 651-657

  Salloway, S ^a,f   Ferris, S ^b   Kluger, A ^b,c   Goldman, R ^d   Griesing, T ^d   Kumar, D ^e   Richardson, S ^e  

^a BROWN UNIVERSITY   (United States)

^b NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CITY UNIVERSITY OF NEW YORK   (United States)

^d PFIZER INC   (United States)

^e EISAI INC   (United States)

^f BUTLER HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DONEPEZIL; PHYSOSTIGMINE; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; COGNITIVE DEFECT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DOSE CALCULATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HIGH RISK PATIENT; HUMAN; INSOMNIA; LEG CRAMP; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUROPSYCHOLOGICAL TEST; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RECALL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SIDE EFFECT; VOMITING;

EID: 4143052423     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/01.WNL.0000134664.80320.92     Document Type: Article

References (38)

1. Morris JC, Storandt M, Miller JP, et al. Mild cognitive impairment represents early-stage Alzheimer's disease. Arch Neurol 2001;58:397-405.
2. Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome [published erratum 1999;56:760]. Arch Neurol 1999;56:303-308.
3. Almkvist O, Basun H, Backman L, et al. Mild cognitive impairment-an early stage of Alzheimer's disease? J Neural Transm Suppl 1998;54:21-29.
4. Shah Y, Tangalos EG, Petersen RC. Mild cognitive impairment. When is it a precursor to Alzheimer's disease? Geriatrics 2000;55:62, 65-68.
5. Collie A, Maruff P. The neuropsychology of preclinical Alzheimer's disease and mild cognitive impairment. Neurosci Biobehav Rev 2000;24: 365-374.
6. Petersen RC, Doody R, Kurz A, et al. Current concepts in mild cognitive impairment. Arch Neurol 2001;58:1985-1992.
7. Wolf H, Grunwald M, Ecke G, et al. The prognosis of mild cognitive impairment in the elderly. J Neural Transm Suppl 1998;54:31-50.
8. Rubin E, Morris J, Grant E, Vendegna T. Very mild senile dementia of the Alzheimer type. I. Clinical assessment. Arch Neurol 1989;46: 379-382.
9. Kluger A, Ferris SH, Golomb J, Mittelman MS, Reisberg B. Neuropsychological prediction of decline to dementia in nondemented elderly. J Geriatr Psychiatry Neurol 1999;12:168-179.
10. de Leon MJ, Golomb J, George AE, et al. The radiologic prediction of Alzheimer disease: the atrophic hippocampal formation. AJNR Am J Neuroradiol 1993;14:897-906.
11. Gauthier S. Update on diagnostic methods, natural history and outcome variables in Alzheimer's disease. Dement Geriatr Cogn Disord 1998;9(suppl 3):2-7.
12. Knapp MJ, Knopman DS, Solomon PR, Pendlebury WW, Davis CS, Gracon SI, for the Tacrine Study Group. A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. JAMA 1994;271:985-991.
13. 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.
14. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT, for 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.
15. Corey-Bloom J, Anand R, Veach J. A randomized trial evaluating the efficacy and safety of ENA 713 (rivastigmine tartrate), a new acetylcholinesterase inhibitor, in patients with mild to moderately severe Alzheimer's disease. Int J Geriatr Psychopharmacol 1998;1:55-65.
16. Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C, for the Galantamine USA-10 Study Group. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology 2000;54:2269-2276.
17. Mohs RC, Doody RS, Morris JC, et al. A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients [published erratum 2001;57:1942]. Neurology 2001;57:481-488.
18. Winblad B, Engedal K, Soininen H, et al. A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD. Neurology 2001;57:489-495.
19. Geldmacher DS, Provenzano G, McRae T, Mastey V, Ieni JR. Donepezil is associated with delayed nursing home placement in patients with Alzheimer's disease. J Am Geriatr Soc 2003;51:937-944.
20. Lopez OL, Becker JT, Wisniewski S, Saxton J, Kaufer DI, DeKosky ST. Cholinesterase inhibitor treatment alters the natural history of Alzheimer's disease. J Neurol Neurosurg Psychiatry 2002;72: 310-314.
21. Seltzer B, Zolnouni P, Nunez M, et al. Donepezil treatment benefits in early-stage Alzheimer's disease. J Am Geriatr Soc 2003;51:S100-S101. Abstract P170.
22. Davis KL, Mohs RC, Tinklenberg JR, Pfefferbaum A, Hollister LE, Kopell BS. Physostigmine: improvement of long-term memory processes in normal humans. Science 1978;201:272-274.
23. Yesavage JA, Mumenthaler MS, Taylor JL, et al. Donepezil and flight simulator performance: effects on retention of complex skills. Neurology 2002;59:123-125.
24. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189-198.
25. Morris JC. The clinical dementia rating (CDR): current version and scoring rules. Neurology 1993;43:2412-2414.
26. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62.
27. Lezak M. Neuropsychological assessment. 3rd ed. New York, NY: Oxford University Press, 1995.
28. Rosen WG, Terry RD, Fuld PA, Katzman R, Peck A. Pathological verification of ischemic score in differentiation of dementias. Ann Neurol 1980;7:486-488.
29. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. Fourth edition, Text revision. Washington, DC: American Psychiatric Association, 2000.
30. Schneider LS, Olin JT, Doody RS, et al. Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11(suppl 2):S22-S32.
31. Mohs RC, Knopman D, Petersen RC, et al. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11(suppl 2):S13-S21.
32. Smith A. Symbol digit modalities test. Los Angeles, CA: Western Psychological Service, 1982.
33. Morris JC, Heyman A, Mohs RC, et al. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology 1989;39: 1159-1165.
34. Olin JT, Schneider LS, Doody RS, et al. Clinical evaluation of global change in Alzheimer's disease: identifying consensus. J Geriatr Psychiatry Neurol 1996;9:176-180.
35. Kluger A, Gianutsos J, Golomb J, et al. Patterns of motor impairment in normal aging, mild cognitive decline, and early Alzheimer's disease. J Gerontol B Psychol Sci Soc Sci 1997;52:P28-P39.
36. Flicker C, Ferris SH, Reisberg B. Mild cognitive impairment in the elderly: predictors of dementia. Neurology 1991;41:1006-1009.
37. Storandt M, Hill R. Very mild senile dementia of the Alzheimer type. II. Psychometric test performance. Arch Neurol 1989;46:383-386.
38. Storandt M, Botwinick J, Danziger W, Berg L, Hughes C. Psychometric differentiation of mild senile dementia of the Alzheimer type. Arch Neurol 1984;41:497-499.