OBJECTIVE: To determine if results from randomized clinical trials of donepezil in Alzheimer disease (AD) patients can be applied to AD patients in clinical practice by comparing the findings from a Nordic one-year randomized AD donepezil trial with data from a one-year prospective, observational study of AD patients. METHODS: AD patients from a consortium of California sites were systematically followed for at least one year. Their treatment regimens, including prescription of donepezil, were determined by their individual physician according to his or her usual criteria. RESULTS: The 148 California patients treated with donepezil had a one-year decline of 1.3 (3.5 SD) points on the Mini-Mental State Exam compared to a decline of 3.3 (4.4 SD) in the 158 AD patients who received no anti-Alzheimer drugs. The Mini-Mental State Exam decline in Nordic sample was approximately 0.25 points for the 91 patients receiving donepezil and approximately 2.2 for the 98 placebo patients. The overall effect sizes were estimated at about 0.49 in both studies. The California data were further analyzed using propensity methods; after taking into account differences that could bias prescribing decisions, benefits associated with taking donepezil remained. CONCLUSION: A comparison of a randomized clinical trial of donepezil in AD patients and this observational study indicates that if appropriate methodological and statistical precautions are undertaken, then results from randomized clinical trials can be predictive with AD patients in clinical practice. This California study supports the modest effectiveness of donepezil in AD patients having clinical characteristics similar to those of the Nordic study.
OBJECTIVE: To determine if results from randomized clinical trials of donepezil in Alzheimer disease (AD) patients can be applied to ADpatients in clinical practice by comparing the findings from a Nordic one-year randomized ADdonepezil trial with data from a one-year prospective, observational study of ADpatients. METHODS:ADpatients from a consortium of California sites were systematically followed for at least one year. Their treatment regimens, including prescription of donepezil, were determined by their individual physician according to his or her usual criteria. RESULTS: The 148 California patients treated with donepezil had a one-year decline of 1.3 (3.5 SD) points on the Mini-Mental State Exam compared to a decline of 3.3 (4.4 SD) in the 158 ADpatients who received no anti-Alzheimer drugs. The Mini-Mental State Exam decline in Nordic sample was approximately 0.25 points for the 91 patients receiving donepezil and approximately 2.2 for the 98 placebo patients. The overall effect sizes were estimated at about 0.49 in both studies. The California data were further analyzed using propensity methods; after taking into account differences that could bias prescribing decisions, benefits associated with taking donepezil remained. CONCLUSION: A comparison of a randomized clinical trial of donepezil in ADpatients and this observational study indicates that if appropriate methodological and statistical precautions are undertaken, then results from randomized clinical trials can be predictive with ADpatients in clinical practice. This California study supports the modest effectiveness of donepezil in ADpatients having clinical characteristics similar to those of the Nordic study.
Authors: Jared R Tinklenberg; Helena C Kraemer; Kristine Yaffe; Ruth O'Hara; John M Ringman; John W Ashford; Jerome A Yesavage; Joy L Taylor Journal: Am J Geriatr Psychiatry Date: 2014-09-28 Impact factor: 4.105
Authors: Lori A Newkirk; Virginia L Dao; Joshua T Jordan; Loren I Alving; Helen D Davies; Linda Hewett; Sherry A Beaudreau; Logan D Schneider; Christine E Gould; Christina F Chick; Rayna B Hirst; Sophia Miryam Schüssler-Fiorenza Rose; Lauren A Anker; Jared R Tinklenberg; Ruth O'Hara Journal: J Alzheimers Dis Date: 2020 Impact factor: 4.472
Authors: J Wesson Ashford; Ahmad Salehi; Ansgar Furst; Peter Bayley; Giovanni B Frisoni; Clifford R Jack; Osama Sabri; Maheen M Adamson; Kerry L Coburn; John Olichney; Norbert Schuff; Daniel Spielman; Steven D Edland; Sandra Black; Allyson Rosen; David Kennedy; Michael Weiner; George Perry Journal: J Alzheimers Dis Date: 2011 Impact factor: 4.472
Authors: J Wesson Ashford; Soo Borson; Ruth O'Hara; Paul Dash; Lori Frank; Philippe Robert; William R Shankle; Mary C Tierney; Henry Brodaty; Frederick A Schmitt; Helena C Kraemer; Herman Buschke; Howard Fillit Journal: Alzheimers Dement Date: 2007-04 Impact factor: 21.566
Authors: F Nourhashémi; M G Olde Rikkert; A Burns; B Winblad; G B Frisoni; J Fitten; B Vellas Journal: J Nutr Health Aging Date: 2010-02 Impact factor: 4.075
Authors: Soo Borson; Lori Frank; Peter J Bayley; Malaz Boustani; Marge Dean; Pei-Jung Lin; J Riley McCarten; John C Morris; David P Salmon; Frederick A Schmitt; Richard G Stefanacci; Marta S Mendiondo; Susan Peschin; Eric J Hall; Howard Fillit; J Wesson Ashford Journal: Alzheimers Dement Date: 2013-01-30 Impact factor: 21.566
Authors: Katherine A Gifford; Dandan Liu; Zengqi Lu; Yorghos Tripodis; Nicole G Cantwell; Joseph Palmisano; Neil Kowall; Angela L Jefferson Journal: Alzheimers Dement Date: 2013-07-16 Impact factor: 21.566
Authors: J Winchester; M B Dick; D Gillen; B Reed; B Miller; J Tinklenberg; D Mungas; H Chui; D Galasko; L Hewett; C W Cotman Journal: Arch Gerontol Geriatr Date: 2012-09-05 Impact factor: 3.250