Author Contributions: Dr Quinn 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: Quinn, Yurko-Mauro, Nelson, Weiner, Shinto, Aisen.
Acquisition of data: Quinn, van Dyck, Galvin, Weiner, Aisen.
Analysis and interpretation of data: Quinn, Raman, Thomas, Nelson, van Dyck, Emond, Jack, Weiner, Aisen.
Drafting of the manuscript: Quinn, Raman, Galvin, Emond.
Critical revision of the manuscript for important intellectual content: Quinn, Raman, Thomas, Yurko-Mauro, Nelson, van Dyck, Galvin, Jack, Weiner, Shinto, Aisen.
Statistical analysis: Raman, Thomas, Emond, Aisen.
Obtained funding: Quinn, Nelson, Weiner, Shinto, Aisen.
Administrative, technical, or material support: Raman, Yurko-Mauro, Nelson, van Dyck, Jack, Weiner, Aisen.
Study supervision: Quinn, van Dyck, Aisen.
Financial Disclosures: Drs Yurko-Mauro and Nelson reported being employees of Martek Biosciences, manufacturers of docosahexaenoic acid (DHA). Drs Quinn and Aisen reported being named as co-inventors on a patent for DHA for the treatment of Alzheimer disease in apolipoprotein E ε4–negative individuals, which was filed in July 2009 with Dr Yurko-Mauro as the inventor. Data lock for this trial was completed June 2009, the primary analysis was completed and results presented in July 2009, the patent was filed by Martek Biosciences in July 2009. Drs Quinn and Aisen were added as co-inventors in February 2010. Drs Quinn and Aisen have waived personal rights to royalties related to this patent. No other authors reported disclosures.
Funding/Support: This study was supported by grant UO1-AG10483 from the National Institute on Aging. The placebo and DHA study drugs were provided by Martek Biosciences. Martek also provided plasma and cerebrospinal fluid measurements of fatty acids, as well as partial financial support for the magnetic resonance imaging substudy.
Role of the Sponsor: The study design was approved by an oversight committee of the National Institute on Aging. Representatives from the National Institute on Aging participated in meetings of the steering committee of the Alzheimer's Disease Cooperative Study during the course of the trial. The National Institute on Aging was not otherwise involved in the design and conduct of the study, or in the analysis of data or preparation of the manuscript. Martek employees participated in design of the study and in revision of the manuscript, but were not involved in data management or data analysis.
Independent Statistical Analysis: The statistical analysis was conducted by the Alzheimer's Disease Cooperative Study Data Core. Martek employees did not participate in the statistical analysis and did not have access to the data prior to the completion of data analysis.
Alzheimer’s Disease Cooperative Study Group Investigators: Lon Schneider, MD (University of Southern California, Los Angeles), Michael Rafii, MD (University of California, San Diego), Nancy Barbas, MD (University of Michigan, Ann Arbor), David Knopman, MD (Mayo Clinic, Rochester, Minnesota), Rachelle Doody (Baylor College of Medicine, Houston, Texas), Karen Bell, MD (Columbia University, New York, New York), James Galvin, MD (New York University School of Medicine, New York), Daniel Marson, PhD (University of Alabama, Birmingham), Mary Sano, PhD (Mt Sinai School of Medicine, New York, New York), Raj Shah, MD (Rush University Medical Center, Chicago, Illinois), Ranjan Duara, MD (Wien Center for Clinical Research, Miami, Florida), Marilyn Albert, PhD (Johns Hopkins School of Medicine, Baltimore, Maryland), Amanda Smith, MD (University of South Florida, Tampa), Steven Ferris, PhD (New York University Medical Center, New York), Gregory Jicha, MD (University of Kentucky, Lexington), Oscar Lopez, MD (University of Pittsburgh, Pittsburgh, Pennsylvania), Anton Porsteinsson, MD (University of Rochester, Rochester, New York), Ruth Mulnard, PhD (University of California, Irvine), Myron Weiner, MD (University of Texas Southwestern Medical Center, Dallas), James Lah, MD (Emory University, Atlanta, Georgia), Jeffrey Burns, MD (University of Kansas, Lawrence), John Ringman, MD (University of California, Los Angeles), Neill Graff-Radford, MD (Mayo Clinic, Jacksonville, Florida), Martin Farlow, MD (Indiana University, Bloomington), Christopher van Dyck, MD (Yale University School of Medicine, New Haven, Connecticut), Paul Solomon, MD (Memory Clinic, Bennington, Vermont), Jacobo Mintzner, MD (University of South Carolina, Columbia), George Grossberg, MD (St Louis University, St Louis, Missouri), Scott McGinnis, MD (Brigham and Women's Hospital, Boston, Massachusetts), Marwan Sabbagh, MD (Banner Sun Health Research Institute, Sun City, Arizona), Anil Nair, MD (Boston University, Boston, Massachusetts), Thomas Obisesan, MD (Howard University, Washington, DC), Stephen Thein, PhD (Pacific Research Network, San Diego, California), Paula Ogrocki, MD (Case Western Reserve University, Cleveland, Ohio), Charles DeCarli, MD (University of California, Davis), Horacio Capote, MD (Dent Neurologic Institute, Amherst, New York), Sanjay Asthana, MD (University of Wisconsin, Madison), Pierre Tariot, MD (Banner Research Institute, Phoenix, Arizona), Douglas Scharre, MD (Ohio State University, Columbus), Earl Zimmerman, MD (Albany Medical College, Albany, New York), Kevin Foley, MD (St Mary's Health Care, Grand Rapids, Michigan), Jeff Williamson, MD (Wake Forest University School of Medicine, Winston-Salem, North Carolina), Elaine Peskind, MD (University of Washington, Seattle), Brian Ott, MD (Rhode Island Hospital, Providence), Wesson Ashford, MD (Stanford University, Palo Alto, California), Gary Duncan, MD (Meharry Medical Clinic, Nashville, Tennessee), Paul Aisen, MD (Georgetown University, Washington, DC), and Chuang-Kuo Wu, MD (Northwestern University, Chicago, Illinois).
Data and Safety Monitoring Board: Karl Kieburtz, MD (University of Rochester School of Medicine and Dentistry, Rochester, New York), Bruce Miller, MD (University of California, San Francisco), Richard Kryscio, PhD (University of Kentucky, Lexington), and George Alexopoulos, MD (Weill Cornell Medical College, New York, New York).
Clinical Monitors: Karen Croot, BA, Viviana Messick, BS, Alan Pamoleras, BA, and Rebecca Ryan-Jones, PhD (all with the University of California, San Diego), Gina Garcia-Camillo, MD, and Mario Schittini, MD, MPH (Mount Sinai School of Medicine, Bronx, New York), Kris Gravanda Brugger, BA, and Pamela Saunders, PhD (Georgetown University, Washington, DC); and Janet Kastelan, MA (New York University, New York).