Skip to main content
PMC home page
Journal of the National Medical Association logoLink to Journal of the National Medical Association
. 2006 Oct;98(10):1590–1597.

Safety and efficacy of donepezil in African Americans with mild-to-moderate Alzheimer's disease.

Patrick Griffith 1, Peter Lichtenberg 1, Robert Goldman 1, Jennifer Payne-Parrish 1
PMCID: PMC2569765  PMID: 17052048

Abstract

BACKGROUND: African Americans have a higher incidence and prevalence of Alzheimer's disease (AD) than whites but have been underrepresented in clinical trials, including studies of cholinesterase inhibitors. PURPOSE: The purpose of this 12-week, open-label study was to evaluate the efficacy and safety of donepezil in African Americans with mild-to-moderate AD. METHODS: Efficacy was assessed via the Mini-Mental State Examination (MMSE), Clinician's Interview-Based Impression of Change-Plus interview with the patient and caregiver (CIBIC-Plus) and Fuld Object Memory Evaluation (FOME), a measure that has been validated for use with elderly African Americans. RESULTS: Significant improvements were observed in cognition (MMSE), global function (CIBIC-Plus) and memory (all four subscales of the FOME). Donepezil was well tolerated; 51% of patients experienced adverse events, most commonly diarrhea (5.6%), hypertension (5.6%) and urinary tract infection (4.8%). CONCLUSIONS: These results suggest that donepezil is effective and safe in treating African Americans with mild-to-moderate AD, and support the value of FOME in assessing efficacy in AD trials in diverse populations.

Full text

PDF
1590

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Burns A., Rossor M., Hecker J., Gauthier S., Petit H., Möller H. J., Rogers S. L., Friedhoff L. T. The effects of donepezil in Alzheimer's disease - results from a multinational trial. Dement Geriatr Cogn Disord. 1999 May-Jun;10(3):237–244. doi: 10.1159/000017126. [DOI] [PubMed] [Google Scholar]
  2. Crum R. M., Anthony J. C., Bassett S. S., Folstein M. F. Population-based norms for the Mini-Mental State Examination by age and educational level. JAMA. 1993 May 12;269(18):2386–2391. [PubMed] [Google Scholar]
  3. DeKosky Steven. Early intervention is key to successful management of Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Jul-Sep;17 (Suppl 4):S99–104. doi: 10.1097/00002093-200307004-00004. [DOI] [PubMed] [Google Scholar]
  4. Demirovic Jasenka, Prineas Ronald, Loewenstein David, Bean Judy, Duara Ranjan, Sevush Steven, Szapocznik Jose. Prevalence of dementia in three ethnic groups: the South Florida program on aging and health. Ann Epidemiol. 2003 Jul;13(6):472–478. doi: 10.1016/s1047-2797(02)00437-4. [DOI] [PubMed] [Google Scholar]
  5. Feldman H., Gauthier S., Hecker J., Vellas B., Subbiah P., Whalen E., Donepezil MSAD Study Investigators Group A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease. Neurology. 2001 Aug 28;57(4):613–620. doi: 10.1212/wnl.57.4.613. [DOI] [PubMed] [Google Scholar]
  6. Feldman Howard, Gauthier Serge, Hecker Jane, Vellas Bruno, Emir Birol, Mastey Vera, Subbiah Ponni, Donepezil MSAD Study Investigators Group Efficacy of donepezil on maintenance of activities of daily living in patients with moderate to severe Alzheimer's disease and the effect on caregiver burden. J Am Geriatr Soc. 2003 Jun;51(6):737–744. doi: 10.1046/j.1365-2389.2003.51260.x. [DOI] [PubMed] [Google Scholar]
  7. Fitzpatrick Annette L., Kuller Lewis H., Ives Diane G., Lopez Oscar L., Jagust William, Breitner John C. S., Jones Beverly, Lyketsos Constantine, Dulberg Corinne. Incidence and prevalence of dementia in the Cardiovascular Health Study. J Am Geriatr Soc. 2004 Feb;52(2):195–204. doi: 10.1111/j.1532-5415.2004.52058.x. [DOI] [PubMed] [Google Scholar]
  8. Flack John M., Ferdinand Kieth C., Nasser Samar A. Epidemiology of hypertension and cardiovascular disease in African Americans. J Clin Hypertens (Greenwich) 2003 Jan-Feb;5(1 Suppl 1):5–11. doi: 10.1111/j.1524-6175.2003.02152.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Folstein M. F., Folstein S. E., McHugh P. R. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189–198. doi: 10.1016/0022-3956(75)90026-6. [DOI] [PubMed] [Google Scholar]
  10. Gauthier S., Feldman H., Hecker J., Vellas B., Emir B., Subbiah P., Donepezil MSAD Study Investigators' Group Functional, cognitive and behavioral effects of donepezil in patients with moderate Alzheimer's disease. Curr Med Res Opin. 2002;18(6):347–354. doi: 10.1185/030079902125001029. [DOI] [PubMed] [Google Scholar]
  11. Gauthier Serge, Feldman Howard, Hecker Jane, Vellas Bruno, Ames David, Subbiah Ponni, Whalen Edward, Emir Birol, Donepezil MSAD Study Investigators Group Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer's disease. Int Psychogeriatr. 2002 Dec;14(4):389–404. doi: 10.1017/s104161020200858x. [DOI] [PubMed] [Google Scholar]
  12. Hargrave R., Stoeklin M., Haan M., Reed B. Clinical aspects of Alzheimer's disease in black and white patients. J Natl Med Assoc. 1998 Feb;90(2):78–84. [PMC free article] [PubMed] [Google Scholar]
  13. La Rue A., D'Elia L. F., Clark E. O., Spar J. E., Jarvik L. F. Clinical tests of memory in dementia, depression, and healthy aging. Psychol Aging. 1986 Mar;1(1):69–77. doi: 10.1037//0882-7974.1.1.69. [DOI] [PubMed] [Google Scholar]
  14. La Rue A. Patterns of performance on the Fuld Object Memory Evaluation in elderly inpatients with depression or dementia. J Clin Exp Neuropsychol. 1989 Aug;11(4):409–422. doi: 10.1080/01688638908400902. [DOI] [PubMed] [Google Scholar]
  15. Leifer Bennett P. Early diagnosis of Alzheimer's disease: clinical and economic benefits. J Am Geriatr Soc. 2003 May;51(5 Suppl DEMENTIA):S281–S288. doi: 10.1046/j.1532-5415.5153.x. [DOI] [PubMed] [Google Scholar]
  16. Manly J. J., Jacobs D. M., Sano M., Bell K., Merchant C. A., Small S. A., Stern Y. Effect of literacy on neuropsychological test performance in nondemented, education-matched elders. J Int Neuropsychol Soc. 1999 Mar;5(3):191–202. doi: 10.1017/s135561779953302x. [DOI] [PubMed] [Google Scholar]
  17. Mast B. T., Fitzgerald J., Steinberg J., MacNeill S. E., Lichtenberg P. A. Effective screening for Alzheimer's disease among older African Americans. Clin Neuropsychol. 2001 May;15(2):196–202. doi: 10.1076/clin.15.2.196.1892. [DOI] [PubMed] [Google Scholar]
  18. Meyer J. S., Rauch G. M., Rauch R. A., Haque A., Crawford K. Cardiovascular and other risk factors for Alzheimer's disease and vascular dementia. Ann N Y Acad Sci. 2000 Apr;903:411–423. doi: 10.1111/j.1749-6632.2000.tb06393.x. [DOI] [PubMed] [Google Scholar]
  19. Mohs R. C., Doody R. S., Morris J. C., Ieni J. R., Rogers S. L., Perdomo C. A., Pratt R. D., "312" Study Group A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients. Neurology. 2001 Aug 14;57(3):481–488. doi: 10.1212/wnl.57.3.481. [DOI] [PubMed] [Google Scholar]
  20. Olin J. T., Schneider L. S., Doody R. S., Clark C. M., Ferris S. H., Morris J. C., Reisberg B., Schmitt F. A. Clinical evaluation of global change in Alzheimer's disease: identifying consensus. J Geriatr Psychiatry Neurol. 1996 Oct;9(4):176–180. doi: 10.1177/089198879600900404. [DOI] [PubMed] [Google Scholar]
  21. Plehn Kirsten, Marcopulos Bernice A., McLain Carol A. The relationship between neuropsychological test performance, social functioning, and instrumental activities of daily living in a sample of rural older adults. Clin Neuropsychol. 2004 Feb;18(1):101–113. doi: 10.1080/13854040490507190. [DOI] [PubMed] [Google Scholar]
  22. Quesada J. J., Ferrucci L., Calvani D., Valente C., Salani B., Bavazzano A. Formal education as an effect modifier of the relationship between Mini-Mental State Examination score and IADLs disability in the older population. Aging (Milano) 1997 Jun;9(3):175–179. doi: 10.1007/BF03340146. [DOI] [PubMed] [Google Scholar]
  23. Rogers S. L., Doody R. S., Mohs R. C., Friedhoff L. T. Donepezil improves cognition and global function in Alzheimer disease: a 15-week, double-blind, placebo-controlled study. Donepezil Study Group. Arch Intern Med. 1998 May 11;158(9):1021–1031. doi: 10.1001/archinte.158.9.1021. [DOI] [PubMed] [Google Scholar]
  24. Rogers S. L., Farlow M. R., Doody R. S., Mohs R., Friedhoff L. T. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology. 1998 Jan;50(1):136–145. doi: 10.1212/wnl.50.1.136. [DOI] [PubMed] [Google Scholar]
  25. Rogers S. L., Friedhoff L. T. The efficacy and safety of donepezil in patients with Alzheimer's disease: results of a US Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. The Donepezil Study Group. Dementia. 1996 Nov-Dec;7(6):293–303. doi: 10.1159/000106895. [DOI] [PubMed] [Google Scholar]
  26. Shadlen M. F., Larson E. B., Gibbons L., McCormick W. C., Teri L. Alzheimer's disease symptom severity in blacks and whites. J Am Geriatr Soc. 1999 Apr;47(4):482–486. doi: 10.1111/j.1532-5415.1999.tb07244.x. [DOI] [PubMed] [Google Scholar]
  27. Tang M. X., Cross P., Andrews H., Jacobs D. M., Small S., Bell K., Merchant C., Lantigua R., Costa R., Stern Y. Incidence of AD in African-Americans, Caribbean Hispanics, and Caucasians in northern Manhattan. Neurology. 2001 Jan 9;56(1):49–56. doi: 10.1212/wnl.56.1.49. [DOI] [PubMed] [Google Scholar]
  28. Tariot P. N., Cummings J. L., Katz I. R., Mintzer J., Perdomo C. A., Schwam E. M., Whalen E. A randomized, double-blind, placebo-controlled study of the efficacy and safety of donepezil in patients with Alzheimer's disease in the nursing home setting. J Am Geriatr Soc. 2001 Dec;49(12):1590–1599. [PubMed] [Google Scholar]
  29. Weiss B. D., Reed R., Kligman E. W., Abyad A. Literacy and performance on the Mini-Mental State Examination. J Am Geriatr Soc. 1995 Jul;43(7):807–810. doi: 10.1111/j.1532-5415.1995.tb07057.x. [DOI] [PubMed] [Google Scholar]
  30. Whitehead Anne, Perdomo Carlos, Pratt Raymond D., Birks Jacqueline, Wilcock Gordon K., Evans John Grimley. Donepezil for the symptomatic treatment of patients with mild to moderate Alzheimer's disease: a meta-analysis of individual patient data from randomised controlled trials. Int J Geriatr Psychiatry. 2004 Jul;19(7):624–633. doi: 10.1002/gps.1133. [DOI] [PubMed] [Google Scholar]
  31. Winblad B., Engedal K., Soininen H., Verhey F., Waldemar G., Wimo A., Wetterholm A. L., Zhang R., Haglund A., Subbiah P. A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD. Neurology. 2001 Aug 14;57(3):489–495. doi: 10.1212/wnl.57.3.489. [DOI] [PubMed] [Google Scholar]

Articles from Journal of the National Medical Association are provided here courtesy of National Medical Association

RESOURCES