Accepted for Publication: January 19, 2012.
Published Online: April 2, 2012. doi:10.1001/archneurol.2012.90
Author Contributions: All authors had access to the study data in the form of statistical tables and figures that were generated by the data analyst (J.W.). Study concept and design: Blennow, Black, Grundman, and Liu. Acquisition of data: Blennow, Zetterberg, Rinne, Salloway, and Liu. Analysis and interpretation of data: Blennow, Zetterberg, Salloway, Wei, Black, Grundman, and Liu. Drafting of the manuscript: Blennow, Grundman, and Liu. Critical revision of the manuscript for important intellectual content: Blennow, Zetterberg, Rinne, Salloway, Wei, Black, Grundman, and Liu. Statistical analysis: Wei and Grundman. Obtained funding: Liu. Administrative, technical, and material support: Blennow, Zetterberg, and Grundman. Study supervision: Blennow and Liu.
Group Members: Investigators in Study 201: R. Doody, S. Rosentree, S. Awosika-Olumo, J. Sims, M. Chowdhury, Baylor College of Medicine, Houston, Tex; M. Brody, D. Watson, C. Bouchard, G. Barbati, L. Brody, Brain Matters Research Inc, Delray Beach, Fla; R. Sperling, G. Marshall, D. Wolk, M. Vander Vliet, S. Salisbury, D. Rentz, Brigham & Women's Hospital, Boston, Mass; S. Salloway, P. Malloy, B. Blackham, S. Correia, D. Cimini, Butler Hospital, Providence, RI; M. Sabbagh, J. Ceimo, J. Lopez, K. Davis, D. Connor, Cleo Roberts Center for Clinical Research/Sun Health Research Institute, Sun City, Ariz; P. Solomon, L. Catapane-Friedman, P. Levin, C. Holland, M. Robinson, Clinical Neuroscience Research Associates Inc, Bennington, VT; K. Bell, L. Honig, E. Dominguez-Rivera, R. Tejeda, A. Canaan, Columbia University, New York City, NY; J. Beyer, R. Doraiswamy, K. Gersing, M. Aiello, H. Husn, Duke University Medical Center, Durham, NC; P. Aisen, C. Ward, K. Behan, B. Reynolds, Georgetown University Medical Center, Washington, DC; A. Hake, R. Evans, E. Van Hook, K. Cavanaugh, D. Rexroth, Indiana University Medical Center, Indianapolis, Ind; N. Graff-Radford, J. Boughey, R. Fletcher, F. Parfitt, L. Makarov, Mayo Clinic, Jacksonville, Fla; D. Knopman, B. Boeve, N. Haukom, K. Johnson, K. Bailey, K. Wytaske, Mayo Clinic, Rochester, Minn; J. Quinn, J. Kaye, T. Gilmore, K. Wild, F. Ferguson, Oregon Health & Science University, Portland, Ore; C. Wilcox, J. Morrissey, A. Hardy, W. Myrant, Pharmacology Research Institute, Los Alamitos, Calif; D. Grosz, A. Schneider, J. Morrissey, W. Myrant, C. Wilcox, Pharmacology Research Institute, Encino, Calif; L. Taber, L. Kirby, T. Williams, C. McCarthy, T. Footer, S. Fadden, J. Christensen, S. Borwege, Pivotal Research Centers, Peoria, Ariz; N. Aggarwal, R. Shah, N. Lopez-Barbera, S. Carroll, M. Vidaurri, Rush Presbyterian St. Luke's Medical Center, Chicago, Ill; J. Ross, Y. Shi, P. Ponugoti, W. Garcia, L. McGlue, K. Doyle, The Memory Enhancement Center, Eatontown, NJ; C. DeCarli, W. Seavery, C. Conover, K. Sweeny, M. Levallois, J. Campos, B. Faulstich, University of California Davis Medical Center, Sacramento, Calif; A. Boxer, B. Miller, M. Koestler, K. Arnold, N. Belfor, R. Gearhart, University of California at San Francisco; N. Barbas, J. Heidebrink, J. Lord, L. Guidotti, A. Freymuth Caveny, University of Michigan Health System, Ann Arbor; J. Corey-Bloom, G. Tong, K. Wetzel, A. Wilson, G. Tong, University of California–San Diego, La Jolla; R. Mulnard, G. Thai, C. McAdams-Ortiz, B. Yanez, University of California at Irvine; O. Lopez, S. Dekosky, W. Klunk, L. Macedonia, B. Sarles, T. Baumgartner, University of Pittsburgh, Penn; A. Porsteinsson, P. Tariot, B. Goldstein, J. LaFountain, L. Terwilliger, University of Rochester/Monroe Community Hospital, Rochester, NY; R. Rosenberg, K. Womack, D. Svetlik, K. Moser, B. Davis, University of Texas Southwestern Medical Center, Dallas; M. Raskind, E. Peskind, S. Eliza, N. Brown, E. Petrie, VA Medical Center, Seattle, Wash; J. Morris, J. Galvin, C. Tomlinson, W. Overkamp, S. Schneider, Washington University School of Medicine, St Louis, MO; and C. van Dyck, R. Tampi, K. Estok, M. MacAvoy, N. Barcelos, A. Benincasa, M. Sazon, Yale University School of Medicine, New Haven, Conn. Investigators in Study 202: T. Lehtinen, M. Kailajarvi, J. Hilli, P. Ruokomäki, K. Virtanen, T. Kaila, M. Koutu, T. Toikka, M. Scheinin, University of Turku, Turku, Finland; and M. Rossor, W. Knight, J. Douglas, J. Warren, B. Ridha, University College London, Institute of Neurology, London; R. Bullock, A. Narayan, K. Ventkatesh, C. Hall, H. Cartwright, Kingshill Research Centre, Swindon, England.
Financial Disclosure: Dr Blennow has served on scientific advisory boards for Innogenetics and Pfizer as well as on a speaker bureau for Janssen Alzheimer Immunotherapy. Dr Rinne has received research support from Elan/Wyeth. Dr Salloway has served as a consultant for AstraZeneca, Athena, Avid-Lilly, Baxter, Bristol-Myers Squibb, Eisai, Elan, Janssen Alzheimer Immunotherapy, Pfizer, and Sanofi. He has also received honorarium from Athena Diagnostics, Bristol-Myers Squibb, Eisai, Elan, and Pfizer, as well as provided data monitoring for Medivation and Merck-Serono. He has also provided research support to Bayer, Bristol-Myers Squibb, Elan, Eisai, GE, Genentech, Janssen Alzheimer Immunotherapy, Medivation, and Pfizer, as well as to the National Institute on Aging's Alzheimer Disease Neuroimaging Initiative and Dominantly Inherited Alzheimer Network, the Alzheimer Association, the Norman and Rosalie Fain Family Foundation, the John and Happy White Foundation, and the Champlin Foundation. Dr Wei is an employee of Janssen Alzheimer Immunotherapy. Dr Black is an employee of Pfizer. Dr Grundman has been a consultant for Adamas, American Life Science Pharmaceuticals, Avid, Biogen-Idec, Elan, Eli Lilly, Helicon, Intellect Neurosciences, Janssen Alzheimer Immunotherapy, Johnson & Johnson, and Teva Pharmaceuticals. He also owns stock in Elan and has been named on patents associated with Alzheimer immunotherapy. Dr Liu is an employee of Janssen Alzheimer Immunotherapy.
Funding/Support: This study was funded by Elan (acquired by Janssen Alzheimer Immunotherapy in 2009) and Wyeth Pharmaceuticals (acquired by Pfizer in 2009).
Role of the Sponsors: Employees of both sponsor companies (Janssen Alzheimer Immunotherapy and Pfizer) were involved in the study design, collection, analysis, and interpretation of data, as well as in the development and submission of this article.
Additional Contributions: We thank the patients and all of the investigators who took part in this study. We acknowledge the following individuals for their assistance: Cherry Lucas, BA, Erika Jones, BA, and Robert Schilling, MS (study management); Kristen Morris, MS (pharmacovigilence); Rezi Zawadski, PhD, and Keith Gregg, PhD (statistical analyses); John Baer, PhD, and Kay Jing, PhD (clinical study summary); Daniel Kidd, PhD, and Bert Blank, MS (bioanalysis); and Monica Christiansson, BS, and Åsa Kjällén, BS (cerebrospinal fluid analyses). We also thank members of the safety monitoring committee: Sid Gilman, MD, FRCP (chair); Chris Clark, MD; Douglas Galasko, MD; and Diane Griffin, MD, PhD.