Petersen - n engl j med 352;23 www.nejm.org june 9, 2005...

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Unformatted text preview: n engl j med 352;23 www.nejm.org june 9, 2005 2379 The new england journal of medicine established in 1812 june 9 , 2005 vol. 352 no. 23 Vitamin E and Donepezil for the Treatment of Mild Cognitive Impairment Ronald C. Petersen, Ph.D., M.D., Ronald G. Thomas, Ph.D., Michael Grundman, M.D., M.P.H., David Bennett, M.D., Rachelle Doody, M.D., Ph.D., Steven Ferris, Ph.D., Douglas Galasko, M.D., Shelia Jin, M.D., M.P.H., Jeffrey Kaye, M.D., Allan Levey, M.D., Ph.D., Eric Pfeiffer, M.D., Mary Sano, Ph.D., Christopher H. van Dyck, M.D., and Leon J. Thal, M.D., for the Alzheimers Disease Cooperative Study Group* abstract From the Mayo Clinic College of Medicine, Rochester, Minn. (R.C.P.); University of Cal- ifornia, San Diego, San Diego (R.G.T., D.G., S.J., L.J.T.); Elan Pharmaceuticals, San Diego (M.G.); Rush University Medical School, Chicago (D.B.); Baylor College of Medi- cine, Houston (R.D.); New York Univer- sity, New York (S.F.); Oregon Health and Science University, Portland (J.K.); Emory University, Atlanta (A.L.); University of South Florida, Tampa (E.P.); Mt. Sinai School of Medicine, New York (M.S.); and Yale Univer- sity, New Haven, Conn. (C.H.D.). Address reprint requests to Dr. Petersen at the Alz- heimers Disease Research Center, Mayo Clinic College of Medicine, 200 First St. SW, Rochester, MN 55905, or at peter8@mayo. edu. *Members of the Alzheimers Disease Co- operative Study (ADCS) Group are listed in the Appendix. This article was published at www.nejm. org on April 13, 2005. N Engl J Med 2005;352:2379-88. Copyright 2005 Massachusetts Medical Society. background Mild cognitive impairment is a transitional state between the cognitive changes of nor- mal aging and early Alzheimers disease. methods In a double-blind study, we evaluated subjects with the amnestic subtype of mild cognitive impairment. Subjects were randomly assigned to receive 2000 IU of vitamin E daily, 10 mg of donepezil daily, or placebo for three years. The primary outcome was clinically possi- ble or probable Alzheimers disease; secondary outcomes were cognition and function. results A total of 769 subjects were enrolled, and possible or probable Alzheimers disease de- veloped in 212. The overall rate of progression from mild cognitive impairment to Alz- heimers disease was 16 percent per year. As compared with the placebo group, there were no significant differences in the probability of progression to Alzheimers disease in the vitamin E group (hazard ratio, 1.02; 95 percent confidence interval, 0.74 to 1.41; P=0.91) or the donepezil group (hazard ratio, 0.80; 95 percent confidence interval, 0.57 to 1.13; P=0.42) during the three years of treatment. Prespecified analyses of the treat- ment effects at 6-month intervals showed that as compared with the placebo group, the donepezil group had a reduced likelihood of progression to Alzheimers disease dur- ing the first 12 months of the study (P=0.04), a finding supported by the secondary out- come measures. Among carriers of one or more apolipoprotein E come measures....
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Petersen - n engl j med 352;23 www.nejm.org june 9, 2005...

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