Accepted for Publication: January 19, 2012.
Published Online: March 19, 2012. doi:10.1001/archneurol.2012.85
Author Contributions: The authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Galasko, Cotman, Thomas, and Aisen. Acquisition of data: Galasko, Peskind, Clark, Quinn, Ringman, Jicha, Cotman, Cottrell, Montine, and Aisen. Analysis and interpretation of data: Galasko, Quinn, Ringman, Jicha, Cottrell, Thomas, and Aisen. Drafting of the manuscript: Galasko, Cottrell, and Thomas. Critical revision of the manuscript for important intellectual content: Galasko, Peskind, Clark, Quinn, Ringman, Jicha, Cotman, Montine, Thomas, and Aisen. Statistical analysis: Thomas. Obtained funding: Galasko, Montine, and Aisen. Administrative, technical, and material support: Galasko, Peskind, Ringman, Jicha, Cottrell, Thomas, and Aisen. Study supervision: Galasko, Montine, Thomas, and Aisen.
ADCS Investigators: The ADCS investigators and sites in this clinical trial were David Weisman, MD (site principal investigator [PI]), Mary Margaret Pay (study coordinator), University of California, San Diego; Alan Lerner, MD (site PI), Elaine Ziol (study coordinator), Case Western Reserve University, Cleveland, Ohio; Joseph Quinn, MD (site PI), Samantha Raphael (study coordinator), Oregon Health and Sciences University, Portland; Ruth Mulnard, RN, DNSc, FAAN (site PI), Catherine McAdams-Ortiz (study coordinator), University of California, Irvine; John Ringman, MD (site PI), Jenny Bardens (study coordinator), University of California, Los Angeles; Gregory Jicha, MD, PhD (site PI), Sarah Carr (study coordinator), University of Kentucky, Lexington; Christopher M. Clark, MD (site PI), Cassie Pham (study coordinator), University of Pennsylvania, Philadelphia; Elaine Peskind, MD (site PI), Linda Mandelco (study coordinator), University of Washington, Seattle; Aljoeson Walker, MD (site PI), Stephanie Kirbach (study coordinator), Medical University of South Carolina, Charleston; Steven DeKosky, MD (site PI), Carolyn Mishler-Rickard (study coordinator), University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Smita Kittur, MD (site PI), Seema Mirje (study coordinator), Neurological Care of Central New York, Buffalo.
Financial Disclosure: None of the authors have any disclosures regarding the study; the specific antioxidants that were examined; Vitaline Inc (the company that supplied the study drugs and placebo); or the CSF assays that were measured. Dr Galasko serves as editor of Alzheimer's Disease Research and Treatment ; serves on data safety monitoring boards for Elan and Janssen; is an investigator in clinical trials sponsored by Eli Lilly and Avid; and receives research support from National Institutes of Health (NIH) grants P50 AGO5131 (PI) and U01 AG10483 (coinvestigator). Dr Peskind is an investigator in clinical trials sponsored by Eli Lilly, Bristol-Myers Squibb, Novartis, and Medivation and receives research support from NIH grant R01 AGO33133, the Department of Veterans Affairs (VA Cooperative Study 563 [co-PI] and Rehabilitation Research and Development Merit Review), and an anonymous foundation. Dr Clark is the medical director of Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company. Prior to January 2010, he was the director of the Center of Excellence for Research on Neurodegenerative Diseases at the University of Pennsylvania and served on data safety monitoring committees for Elan Pharmaceuticals and Myriad and the diagnostic adjudication committee for a Bristol-Myers Squibb treatment trial. Dr Quinn is on the speakers bureau for Pfizer, Forest, and Novartis. He is an investigator in clinical trials sponsored by Elan, Bristol-Meyers Squibb, Pfizer, and Danone. He is a coinventor on a patent for the use of docosahexaenoic acid for the treatment of AD (Martek Biosciences). He also receives research support from the Department of Veterans Affairs (merit review funding) and NIH grants P50 AGO0817 (PI) and U01 AG10483 (project director). Dr Ringman currently receives research support from National Institute on Aging (NIA) grants P50 AG16570 (PI) and U01 AG032438 (site PI). He has served on an advisory board for Takeda Pharmaceuticals. Dr Jicha is an investigator on clinical trials sponsored by Janssen, Baxter, Pfizer, Medivation, and Danone. He has consulted for Medivation, Martek, and Avanir in clinical trial development. He receives research support from NIH grants P30 AG028383 (coinvestigator), R01 AG019241 (coinvestigator), U01 AG010483 (coinvestigator), R01 HD064993-0110 (coinvestigator), and L30 AG032934 (PI) and from Alzheimer's Association grant NIRG-07-59967 (PI). Dr Cotman receives research support from NIH grants AR47752, AG000096, AG00538, and AG016573. Dr Montine serves as senior editor for Brain Pathology and on the editorial board of the American Journal of Pathology and receives research support from NIH grants P50 NS62684 (PI), R01 ES16754 (PI), T32 ES07032 (PI), R01 AG31892 (PI), U01 AG32984 (coinvestigator), and P50 AGO5136 (coinvestigator). Dr Thomas has served as a consultant for Medivation and Bristol-Myers Squibb. He has also served on the data safety monitoring board for a trial sponsored by Myriad. Dr Aisen serves on a scientific advisory board for NeuroPhage; serves as a consultant to Elan Corporation, Wyeth, Eisai Inc, Schering-Plough Corp, Bristol-Myers Squibb, Eli Lilly and Company, NeuroPhage, Merck & Co, Roche, Amgen, Genentech Inc, Abbott, Pfizer Inc, Novartis, Bayer, Astellas, Dainippon, Biomarin, Solvay, Otsuka, Daiichi, AstraZeneca, Janssen, Medivation, Theravance, Cardeus, and Anavex; receives research support from Pfizer Inc, Baxter International Inc, and NIH NIA grants U01 AG10483 (PI), U01 AG024904 (Coordinating Center director), and R01 AG030048 (PI) and NIH grant R01 AG16381 (coinvestigator); and has received stock options from Medivation and NeuroPhage.
Funding/Support: The study was supported by NIA grant UO1 AG10483.
Role of the Sponsors: The funding agency had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Additional Contributions: The ADCS Data Coordinating Center provided oversight for the conduct and monitoring of the clinical trial.