Author Contributions: Dr Schneider 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: Clark, Bedell, Beach, Mintun, Pontecorvo, Hefti, Carpenter, Flitter, Kung, Sadowsky, Reiman, Skovronsky.
Acquisition of data: Clark, Schneider, Bedell, Beach, Pontecorvo, Flitter, Coleman, Doraiswamy, Fleisher, Sabbagh, Sadowsky, Reiman, Zehntner, Skovronsky.
Analysis and interpretation of data: Clark, Bedell, Bilker, Mintun, Pontecorvo, Hefti, Flitter, Krautkramer, Fleisher, Sadowsky, Skovronsky.
Drafting of the manuscript: Clark, Bedell, Beach, Pontecorvo, Hefti, Flitter, Kung, Fleisher, Sadowsky, Zehntner, Skovronsky.
Critical revision of the manuscript for important intellectual content: Clark, Schneider, Bedell, Beach, Bilker, Mintun, Pontecorvo, Hefti, Carpenter, Krautkramer, Coleman, Doraiswamy, Fleisher, Sabbagh, Sadowsky, Reiman, Skovronsky.
Statistical analysis: Clark, Bedell, Bilker, Skovronsky.
Obtained funding: Kung, Coleman, Skovronsky.
Administrative, technical, or material support: Schneider, Bedell, Beach, Hefti, Carpenter, Flitter, Krautkramer, Doraiswamy, Sadowsky, Skovronsky.
Study supervision: Clark, Beach, Pontecorvo, Flitter, Krautkramer, Kung, Sadowsky, Reiman, Skovronsky.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Clark, Mintun, Pontecorvo, Hefti, Carpenter, and Skovronsky and Messrs Flitter and Krautkramer reported owning Avid stock and/or stock options and being employed by Avid Radiopharmaceuticals Inc. Dr Schneider reported being a consultant for Avid Radiopharmaceuticals and receiving compensation for services. Drs Bedell and Zehntner reported receiving compensation and shares from Biospective Inc. Dr Beach reported receiving funding related to the topic of this article from the National Institute on Aging (grant P30 AG19610), the Arizona Department of Health Services (contract 211002 awarded to the Arizona Alzheimer's Research Center), the Arizona Biomedical Research Commission (contracts 4001, 0011, 05-901 and 1001), Avid Radiopharmaceuticals, Bayer Healthcare Inc, and GE Healthcare. Dr Bilker reported working as consultant for Avid Radiopharmaceuticals on issues related to this study. Dr Kung reported receiving financial support from National Institutes of Health grant AG-0222559; serving on the Avid Scientific Advisory board; participating in the formation of Avid; and being an Avid stockholder. Dr Coleman reported being on the medical advisory board for General Electric Healthcare from 2003-2008; being a consultant for General Electric Healthcare from 2003-2008; receiving a research grant from General Electric Healthcare in 2010; receiving funding for a clinical trial from Molecular Insights Pharmaceuticals in 2010; serving on a medical advisory board for Molecular Insights Pharmaceuticals from 2004-2009; and receiving a grant from Avid to support his participation in this study. Dr Doraiswamy reported receiving research grants (awarded to Duke University); currently or previously serving as an advisor to Forest, Bristol-Myers Squibb, Avid Radiopharmaceuticals, Lundbeck, Medivation, Pfizer, Elan, Eli Lilly, Bayer, Neuroptix, Neuronetrix, Sonexa, Accera, TauRx, Myriad, National Institute on Aging, AstraZeneca, Labopharm, Clarimedix, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Alzheimer's Association, Alzheimer's Foundation, Rutgers University, and the University of California; owning stock in Sonexa; and receiving a grant from Avid (awarded to Duke University) for his participation in this study. Dr Fleisher reported receiving research contracts from Avid Radiopharmaceuticals to the Banner Alzheimer's Institute, from which he receives no personal compensation; being a consultant on a scientific advisory board for Eli Lilly; serving on an advisory board for Elan Pharmaceuticals; and having a pending investigator-initiated grant from Avid Radiopharmaceuticals. Dr Sabbagh reported working as a consultant for Eisai, Pfizer, Amerisciences, Takeda, and GlaxoSmithKline; receiving royalties from Wiley, FT Pearson Press, and Amerisciences; and having grants and contracts with Eli Lilly, Baxter, Bayer, General Electric Healthcare, Bristol-Myers Squibb, Eisai, Janssen, Wyeth/Elan, Avid, and Medivation. Dr Sadowsky reported being on the speaker's bureau and receiving honoraria from Novartis, Forrest, Accera, and Pamlab; and serving on the advisory board for Novartis. Dr Reiman reported serving as a scientific advisor to Amnestix/Sygnis, AstraZeneca, Elan, Eli Lilly, GlaxoSmithKline, Intellect, Siemens, Bayer, Takeda, and Eisai; having research contracts with the National Institute on Aging, Arizona Department of Health Services, AstraZeneca, Avid Radiopharmaceuticals, and Kronos Life Sciences; receiving research grants from the National Institute on Aging, National Institute for Mental Health, the Anonymous Foundation, Nomis Foundation, Banner Alzheimer's Foundation, and the State of Arizona; holding patents for imaging strategy for the screening of AD treatments in laboratory animals (active), biomarker strategy for the evaluation of presymptomatic AD treatments (pending, through Banner Health), statistical strategy for the analysis of complementary complex data sets (pending, through Banner Health), and GAB2 testing in clinical assessment of AD (pending, through Translational Genomics Research Institute); and serving as the executive director for the Banner Alzheimer's Institute and the director of the Arizona Alzheimer's Consortium.
Funding/Support: This study was funded by Avid Radiopharmaceuticals Inc and by grants R01AG031581, P30AG19610, and AG-0222559 from the National Institute on Aging, contract 211002 from the Arizona Department of Health Services, contracts 4001, 0011, 1001, and 05-901 from the Arizona Biomedical Research Commission, and funding from the Michael J. Fox Foundation for Parkinson's Research.
Role of the Sponsor: Avid Radiopharmaceuticals had a role in the design and conduct of the study, Documents Solutions Group (Malvern, Pennsylvania) and Pharmaceutical Product Development Inc (Wilmington, North Carolina) had a role in collection and management of the data, but none had a role in the analysis and interpretation of the data, or in the preparation of the manuscript.
Independent Statistical Analysis: The statistical analysis of the data was conducted independently from the sponsor by coauthor Warren B. Bilker, PhD (Department of Biostatistics and Epidemiology, School of Medicine, University of Pennsylvania, Philadelphia). Dr Bilker received the entire raw data set and ran the analysis and was compensated for this work.
Previous Presentation: Presented in part at the 10th International Conference on Alzheimer's Disease; July 11-16, 2010; Honolulu, Hawaii.
Additional Contributions: We acknowledge the altruism of the participants and their families as well as the contributions of the AV45-A07 research and support staffs at each of the participating sites, all of whom contributed to this study.
This article was corrected for errors on February 15, 2011.