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From the Departments of Neurosciences (Drs. Thal, Grundman, and Thomas, J. Berg) and Family and Preventive Medicine (Dr. Thomas, K. Ernstrom), University of California San Diego School of Medicine, La Jolla, Veterans Affairs San Diego Healthcare System (Dr. Thal), San Diego, and Department of Psychiatry and Behavioral Sciences (Dr. Margolin), Keck School of Medicine, Los Angeles, CA; Suncoast Gerontology Center (Dr. Pfeiffer), University of South Florida, Tampa; University of Texas Southwestern Medical Center (Dr. Weiner), Dallas; and Veterans Affairs Augusta Healthcare System (Dr. Zamrini), GA.
Address correspondence and reprint requests to Dr. L.J. Thal, Department of Neurosciences, University of California San Diego School of Medicine, 9500 Gilman Dr., La Jolla, CA 92093-0624; e-mail: lthal{at}ucsd.edu
Objective: To determine the effect of idebenone on the rate of decline in Alzheimer’s disease (AD).
Methods: A 1-year, multicenter, double-blind, placebo-controlled, randomized trial was conducted. Subjects were over age 50 with a diagnosis of probable AD and had Mini-Mental State Examination (MMSE) scores between 12 and 25. Subjects were treated with idebenone 120, 240, or 360 mg tid, each of which was compared with placebo. Primary outcome measures were the Alzheimer’s Disease Assessment Scale–Cognitive Subcomponent (ADAS-Cog) and a Clinical Global Impression of Change (CGIC). Secondary outcome measures included measurements of activities of daily living, the Behavioral Pathology in Alzheimer’s Disease Rating Scale, and the MMSE.
Results: Five hundred thirty-six subjects were enrolled and randomized to the four groups. Except for a slight difference in age, there were no differences in patient characteristics at baseline. For the primary outcome measures, there were no significant overall differences between the treatment groups in the prespecified four-group design. In an exploratory two-group analysis comparing all three treated groups combined with placebo, drug-treated patients performed better on the ADAS-Cog in both the intent-to-treat (ITT) and completers analyses. There were no differences in the CGIC scores for the ITT or completers analyses in either the four-group or the two-group analyses. There were no overall differences on any of the secondary outcome measures in any of the analyses.
Conclusion: Idebenone failed to slow cognitive decline in AD that was of sufficient magnitude to be clinically significant.
Received May 28, 2002. Accepted in final form July 18, 2003.
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