Author Contributions: Dr Green had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Green, Schneider, Beelen, Wilcock, Swabb, Zavitz.
Acquisition of data: Green, Schneider, Amato, Swabb.
Analysis and interpretation of data: Green, Schneider, Amato, Beelen, Wilcock, Swabb, Zavitz.
Drafting of the manuscript: Green, Schneider, Amato, Beelen, Wilcock, Swabb, Zavitz.
Critical revision of the manuscript for important intellectual content: Green, Schneider, Amato, Beelen, Wilcock, Swabb, Zavitz.
Statistical analysis: Amato.
Obtained funding: Swabb.
Administrative, technical, or material support: Green, Wilcock, Swabb, Zavitz.
Study supervision: Green, Schneider, Swabb, Zavitz.
Financial Disclosures: Dr Green reports having received grant support (but no consulting fees) for this clinical trial from Myriad Pharmaceuticals Inc. He reports receiving grant support from Elan and Eli Lilly. Dr Schneider reports having been a paid consultant to and having received grant support for a clinical trial from Myriad Pharmaceuticals Inc, being an editor on the Cochrane Collaboration's Dementia and Cognitive Improvement Group, which oversees systematic reviews of drugs for cognitive impairment and dementia; receiving a grant from the Alzheimer's Association for developing a registry for dementia and cognitive impairment trials; receiving grant or research support from AstraZeneca, Baxter, Elan Pharmaceuticals, Forest Laboratories, Johnson & Johnson, Eli Lilly, Myriad, Novartis, Pfizer, Takeda, and Wyeth; and having served as a consultant for or receiving consulting fees from Abbott Laboratories, Allergan, Allon, Alzheimer Drug Discovery Foundation, AstraZeneca, Bristol-Myers Squibb, Elan, Eli Lilly, Forest, GlaxoSmithKline, Institute IPSEN, Johnson & Johnson, Lundbeck, Myriad, Medivation, Merck, Novartis, Roche, Sanofi-Aventis, Servier, Schering-Plough, Schwabe, Teva, Toyama, Transition Therapeutics, Voyager, and Wyeth. Dr Wilcock reports having been a paid consultant to and having received grant support from Myriad and having served as a consultant for or receiving consulting fees from Eisai, Evotec, Lundbeck, Marix Drug Development, Myriad Pharmaceuticals, Neuropharm, Novartis, Pfizer, Roche, and Shire Pharmaceuticals. Drs Amato, Beelen, Swabb, and Zavitz, as employees of Myriad Pharmaceuticals Inc, reported having an equity ownership and holding stock options in Myriad Pharmaceuticals Inc.
Funding/Support: This study was primarily supported by Myriad Pharmaceuticals. Dr Green reported that he is supported by National Institutes of Health grants RO1-HG02213, K24-AG027841, P30-AG13846, and M01-RR00533. Dr Wilcock was partly supported by the Oxford Comprehensive Biomedical Research Centre with funding from the UK Department of Health's National Institute for Health Research Biomedical Research Centres funding scheme. The statistical analysis was conducted under the direction of Dr Amato, with assistance from Dr Alfred Balch and Mr Brent Evans, MS, both employees of Myriad Pharmaceuticals.
Role of the Sponsor: Myriad Pharmaceuticals Inc provided all financial and material support for the research, consulted with the authors and the members of the Tarenflurbil Phase 3 Study Group on the study design, monitored the conduct of the study and collection of the data, and assisted the authors in the analysis and interpretation of the data and the preparation and review of the manuscript.
Independent Statistical Analysis: Independent statistical analysis was conducted by Adrienne Cupples, PhD, Department of Biostatistics, Boston University, Boston, Massachusetts. The analysis, for which she received no commercial compensation, is presented in this article.
Additional Contributions: We thank Mary Jackson, RN, for overseeing the clinical operations of this study and Gary Mather, DVM, PhD, DABT, for the pharmacokinetic analyses; both are employees of Myriad Pharmaceuticals. We thank the members of the data and safety monitoring committee: Chris Clark, MD, and Jason Karlawish, MD (University of Pennsylvania), Gerald Faich, MD, MPH (United BioSource), Peter Kowey, MD (Main Line Health Heart Center), and Weichung Shih, PhD (University of Medicine and Dentistry of New Jersey, School of Public Health).
A Complete List of Study Group Investigators is available here.