Donepezil treatment and alzheimer disease: Can the results of randomized clinical trials be applied to alzheimer disease patients in clinical practice?

American Journal of Geriatric Psychiatry

Volumn 15, Issue 11, 2007, Pages 953-960

  Tinklenberg, Jared R ^a,b,d   Kraemer, Helena C ^a,b   Yaffe, Kristine ^c   Ross, Leslie ^c   Sheikh, Javaid ^a,b   Ashford, John W ^a   Yesavage, Jerome A ^a,b   Taylor, Joy L ^a,b  

^a VA PALO ALTO HEALTH CARE SYSTEM   (United States)

^b STANFORD UNIVERSITY   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Alzheimer disease; Clinical practice; Donepezil effectiveness; Observational studies; Propensity analyses

Indexed keywords

CHOLINESTERASE INHIBITOR; DONEPEZIL; MEMANTINE; PLACEBO; TACRINE; INDAN DERIVATIVE; PIPERIDINE DERIVATIVE;

ADD ON THERAPY; ADULT; AGED; ALZHEIMER DISEASE; ARTICLE; CLINICAL ASSESSMENT; CLINICAL PRACTICE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DETERIORATION; DISEASE COURSE; DRUG EFFICACY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MINI MENTAL STATE EXAMINATION; MULTICENTER STUDY; OBSERVATIONAL STUDY; PATIENT COMPLIANCE; PHYSICIAN; PRESCRIPTION; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT INDICATION; TREATMENT OUTCOME; TREATMENT REFUSAL; UNITED STATES; UNSPECIFIED SIDE EFFECT; CLINICAL PROTOCOL; COMPARATIVE STUDY; DRUG UTILIZATION; FOLLOW UP; LONGITUDINAL STUDY; METHODOLOGY; MIDDLE AGED; PSYCHOLOGICAL ASPECT; PSYCHOLOGICAL RATING SCALE; STATISTICS;

ADULT; AGED; AGED, 80 AND OVER; ALZHEIMER DISEASE; CALIFORNIA; CHOLINESTERASE INHIBITORS; CLINICAL PROTOCOLS; DRUG UTILIZATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; INDANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; PHYSICIAN'S PRACTICE PATTERNS; PIPERIDINES; PRESCRIPTIONS, DRUG; PROSPECTIVE STUDIES; PSYCHIATRIC STATUS RATING SCALES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 38449099627     PISSN: 10647481     EISSN: 15457214     Source Type: Journal    
DOI: 10.1097/JGP.0b013e3180986138     Document Type: Article

References (27)

1. Rogers SL, Doody RS, Mohs RC, et al: 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
2. Rogers SL, Farlow MR, Doody RS, et al: A 24-week, double blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology 1998; 50:136-145
3. Winblad B, Engedal K, Soininen H, et al, and the Donepezil Nordic Study Group: a 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD. Neurology 2001; 57:489-495
4. Schneider LS, Olin JT, Lyness SA, et al: Eligibility of Alzheimer's disease clinic patients for clinical trials. J Am Geriatr Soc 1997; 45:923-928
5. Mehta KM, Yin M, Resendez C, et al: Ethnic differences in acetylcholinesterase Inhibitor use for Alzheimer disease. Neurology 2005; 65:159-162
6. McKhann G, Drachman D, Folstein M, et al: Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of the Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology 1984; 34:939-944
7. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. Washington, DC, American Psychiatric Association, 1994
8. Folstein MF, Folstein SE, McHugh PR: "Mini-Mental State": a practical method for grading the cognitive state of subjects for the clinician. J Psychiatr Res 1975; 12:189-198
9. Edwards ER, Lindquist K, Yaffe K: Clinical profile and course of cognitively normal patients evaluated in memory disorders clinics. Neurology 2004; 62:1639-1642
10. Chui HC, Victoroff JI, Margolin D, et al: Criteria for the diagnosis of ischemic vascular dementia proposed by the State of California Alzheimer Disease Diagnostic and Treatment Centers. Neurology 1992; 42:473-480
11. Chul HC, Mack W, Jackson JE, et al: Clinical Criteria for the Diagnosis of Vascular Dementia: A multlcenter study of comparability and interrater reliability. Arch Neurology 2000; 57:191196
12. Salmon DP, Thai IJ, Butters N, et al: Longitudinal evaluation of dementia of the Alzheimer's type: a comparison of three standardized mental status examinations. Neurology 1990; 40:12251230
13. Mungas D, Reed BR: Application of item response theory for development of a global functioning measure of dementia with linear measurement properties. Stat Med 2000; 19:1631-1644
14. Rubin DB: Estimating causal effects from large data sets using propensity scores. Ann Intern Med 1997; 127:757-763
15. D'Agostlno RBJr: Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998; 17:2265-2281
16. Mendiondo MS, Ashford JW, Kryscio RJ, et al: Modeling Mini Mental State Examination changes in Alzheimer's disease. Stat Med 2000; 19:1607-1616
17. Kiernan M, Kraemer HC, Winkleby MA, et al: Do logistic regression and signal detection identify different subgroups at risk? Implications for the design of tailored interventions. Psychol Meth 2001; 6:35-48
18. Kraemer HC, Lowe KK, Kupfer DJ: To Your Health: How To Understand What Research Tells Us About Risk. New York, Oxford University Press, 2005
19. Cohen J. Statistical Power Analysis for the Behavioral Sciences. New York, Academic Press, 1969
20. Huey ED, Taylor JL, Luu PA, et al: Factors associated with use of medications with potential to impair cognition or Cholinesterase Inhibitors among Alzheimer's disease patients. Alzheimer Dement 2006; 2:314-321
21. Galasko D, Abramson I, Corey-Bloom J, et al: Repeated exposure to the Mini-Mental State Examination and the Information-MemoryConcentration Test results in a practice effect in Alzheimer's disease. Neurology 1993; 43:1559-1563
22. Mohs RC, Doody RS, Morris JC, et al: A 1-year placebo controlled preservation of function survival study of donepezil in AD patients. Neurology 2001; 57:481-488
23. Winkleby MA, Flora JA, Kraemer HC: A community-based heart disease intervention: predictors of change. Am J Public Health 1994; 84:767-772
24. Kraemer HC: Reporting the size of effects in research studies to facilitate assessment of practical or clinical significance. Psychoneuroendocrlnology 1992; 17:527-536
25. Ioannidis JP. Contradicted and initially stronger effects in highly cited clinical research. JAMA 2005;294:218-228
26. Humphreys K, Welsner C: Use of exclusion criteria in selecting research subjects and its effect on the generalizibility of alcohol treatment outcome studies. Am J Psychiatry 2000; 157:588-594
27. Rush AJ, Trivedl MH, Wlsniewski SR, et al: Bupropion-SR, sertraline or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med 2006; 354:1231-1242