Salloway, Stephen http://orcid.org/0000-0002-2631-0942
Farlow, Martin
McDade, Eric http://orcid.org/0000-0002-6764-3866
Clifford, David B.
Wang, Guoqiao
Llibre-Guerra, Jorge J. http://orcid.org/0000-0002-2137-7750
Hitchcock, Janice M.
Mills, Susan L.
Santacruz, Anna M. http://orcid.org/0000-0002-4110-6472
Aschenbrenner, Andrew J.
Hassenstab, Jason
Benzinger, Tammie L. S. http://orcid.org/0000-0002-8114-0552
Gordon, Brian A. http://orcid.org/0000-0003-2109-2955
Fagan, Anne M.
Coalier, Kelley A.
Cruchaga, Carlos
Goate, Alison A. http://orcid.org/0000-0002-0576-2472
Perrin, Richard J. http://orcid.org/0000-0002-3443-7716
Xiong, Chengjie
Li, Yan
Morris, John C.
Snider, B. Joy
Mummery, Catherine http://orcid.org/0000-0002-6739-0803
Surti, G. Mustafa
Hannequin, Didier
Wallon, David
Berman, Sarah B.
Lah, James J.
Jimenez-Velazquez, Ivonne Z.
Roberson, Erik D. http://orcid.org/0000-0002-1810-9763
van Dyck, Christopher H.
Honig, Lawrence S. http://orcid.org/0000-0002-9703-2265
Sánchez-Valle, Raquel http://orcid.org/0000-0001-7750-896X
Brooks, William S. http://orcid.org/0000-0001-8603-4233
Gauthier, Serge
Galasko, Douglas R.
Masters, Colin L.
Brosch, Jared R.
Hsiung, Ging-Yuek Robin
Jayadev, Suman
Formaglio, Maité
Masellis, Mario
Clarnette, Roger
Pariente, Jérémie
Dubois, Bruno
Pasquier, Florence http://orcid.org/0000-0001-9880-9788
Jack, Clifford R. Jr http://orcid.org/0000-0001-7916-622X
Koeppe, Robert
Snyder, Peter J. http://orcid.org/0000-0003-0555-4654
Aisen, Paul S.
Thomas, Ronald G. http://orcid.org/0000-0003-1686-4965
Berry, Scott M.
Wendelberger, Barbara A. http://orcid.org/0000-0003-4426-9602
Andersen, Scott W.
Holdridge, Karen C.
Mintun, Mark A.
Yaari, Roy
Sims, John R.
Baudler, Monika
Delmar, Paul
Doody, Rachelle S.
Fontoura, Paulo
Giacobino, Caroline
Kerchner, Geoffrey A.
Bateman, Randall J. http://orcid.org/0000-0002-7729-1702
Formaglio, Maité
Mills, Susan L.
Pariente, Jérémie
van Dyck, Christopher H.
,
Funding for this research was provided by:
U.S. Department of Health & Human Services | NIH | National Institute on Aging (U01AG042791, U01AG042791-S1, R01AG046179, R01AG053267-S1, U19AG032438)
U.S. Department of Health & Human Services | NIH | National Institute on Aging
U.S. Department of Health & Human Services | NIH | National Institute on Aging
Alzheimer’s Association
U.S. Department of Health & Human Services | NIH | National Institute on Aging
Article History
Received: 1 December 2020
Accepted: 23 April 2021
First Online: 21 June 2021
Competing interests
: S.S. was the Project Arm Leader for the gantenerumab arm. He also receives research support and is a consultant to Eisai, Novartis, Genentech, F. Hoffmann-La Roche Ltd, GemVax, Avid Radiopharmaceuticals and Eli Lilly and Company. M. Farlow was the Project Arm Leader for the solanezumab arm. He receives research support and is consultant to Eli Lilly and Company, Eisai, Novartis, Green Valley, AbbVie, Biogen, Eisai, F. Hoffmann-La Roche Ltd, Suvan, vTv Therapeutics, Vaccinex, QR Pharma, Avanir Pharmaceuticals, AZTherapies, Cerecin, Cognition Therapeutics, Cortexyme, Longeveron, Otsuka Pharmaceutical, Samumed and Takeda. A.M.F. is the Biomarker Core Leader of DIAN–TU. She is a member of the scientific advisory boards (SABs) for Roche Diagnostics, Genentech and AbbVie and also consults for Araclon/Grifols, DiademRes, DiamiR and Otsuka Pharmaceuticals. T.L.S.B. has investigator-initiated research funding from the NIH, the Alzheimer’s Association, the Barnes-Jewish Hospital Foundation and Avid Radiopharmaceuticals. She participates as a site investigator in clinical trials sponsored by Avid Radiopharmaceuticals, Eli Lilly and Company, Biogen, Eisai, Janssen and F. Hoffmann-La Roche Ltd. She serves as an unpaid consultant to Eisai and Siemens. She is on the Speaker’s Bureau for Biogen. J.C.M. is the Friedman Distinguished Professor of Neurology, Director of the Charles F. and Joanne Knight Alzheimer’s Disease Research Center, Associate Director of DIAN and Founding Principal Investigator of DIAN. He is funded by NIH grant nos. P30 AG066444, P01AG003991, P01AG026276, U19 AG032438 and U19 AG024904. Neither J.C.M. nor his family owns stock or has equity interest (outside of mutual funds or other externally directed accounts) in any pharmaceutical or biotechnology company. J.H. is an employee of Hitchcock Regulatory Consulting and has consulted for Acumen Pharmaceuticals, Axon Advisors, Critical Path Institute, Gerson Lehrman Group, H. Lundbeck, High Lantern Group, Regenera Pharma Ltd, UCB Biopharma SPRL, United Neuroscience, Vaccinex and Washington University. She is retired from Eli Lilly and Company and is an Eli Lilly and Company shareholder. E.M. is the Associate Director of the DIAN–TU. He reports serving on a Data Safety Committee for Eli Lilly and Company and Alector. He is scientific consultant for Eisai and Eli Lilly and Company and has received institutional grant support from Eli Lilly and Company, F. Hoffmann-La Roche Ltd. and Janssen. D.B.C. is Medical Director of DIAN–TU and serves as scientific consultant to Biogen, Takeda, Millennium, Genzyme, Amgen, F. Hoffmann-La Roche Ltd/Genentech, GlaxoSmithKline, Serono, Inhibikase Therapeutics, Dr Reddy’s Laboratories, Bristol Myers Squibb, Atara, Mitsubishi Tanabe Pharma, Excision BioTherapeutics, UpToDate and Wolters Kluwer. He serves on the Data and Safety Monitoring Board (DSMB)/Data Monitoring Committees for F. Hoffmann-La Roche Ltd/Genentech, Wave, EMD Serono, Shire, Pfizer and Sanofi. He has carried out legal consulting for Cook County, State Farm, Wilke & Wilke PC, Shevlin Smith and Sal Indomenico & Associates PC. He receives research support from the NIH National Institute of Neurological Disorders and Stroke, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, National Center for Advancing Translational Sciences and NIA. A.J.A. has served as a consultant for Biogen and H. Lundbeck. J.H. is a paid consultant for F. Hoffmann-La Roche Ltd, Takeda and H. Lundbeck and is on the Data Safety and Monitoring Board for Eisai. C.R.J. Jr serves on an independent data monitoring board for F. Hoffmann-La Roche Ltd, has consulted for and served as a speaker for Eisai and consulted for Biogen, but he receives no personal compensation from any commercial entity. He receives research support from the NIH and the Alexander Family Alzheimer’s Disease Research Professorship of the Mayo Clinic. C.C. receives research support from Biogen, Eisai, Alector and Parabon. C.C. is a member of the advisory board of Vivid Genetics, Halia Therapeutics and ADx Healthcare. C.M. is a consultant for Biogen. L.S.H. is a consultant for Cortexyme, Eisai, Eli Lilly and Company, Medscape and Prevail. He receives research grant support from Abbvie, Alector, Biogen, Genentech, Eli Lilly and Company and F. Hoffmann-La Roche Ltd. J.P. is on the Speakers’ Bureau for Biogen. E.D.R. is a consultant for Biogen, Applied Genetic Technologies Corporation and AVROBIO, receives funding from Alector and is the owner of intellectual property related to tau. S.G. is a member of the SAB for Alzheon, Biogen, Eli Lilly and Company and TauRx and a member of the Data Safety Monitoring Board for Alzheimer’s Disease Cooperative Study, ATRI and Banner Health. C.H.V.D. has served as a consultant for F. Hoffmann-La Roche Ltd and Eisai and received grant support for clinical trials from F. Hoffmann-La Roche Ltd, Eli Lilly and Company, Biogen, Genetech, Merck, Janssen, Eisai, Novartis and Biohaven Pharmaceuticals. R.S.V. served on a SAB for Ionis Pharmaceuticals. B.D. receives research support from F. Hoffmann-La Roche Ltd. M.M. is a consultant to Arkuda Therapeutics, Ionis and Alector and receives research funding from F. Hoffmann-La Roche Ltd, Novartis and Alector. D.R.G. is a consultant to Biogen, Esai, Fujirebio and Amprion and is on the DSMB for Cognition Therapeutics. G.R.H. has received research support as a clinical trial site investigator for Anavax, Biogen and F. Hoffmann-La Roche Ltd. He has received research funding from the Canadian Institutes of Health Research, Alzheimer Society of Canada and the NIH. P.S.A. collaborates with Eli Lilly and Company and F. Hoffmann-La Roche Ltd on drug development in AD and has a research grant from Eli Lilly and Company. M.B., P.D., R.S.D., P.F., C.G. and G.A.K. are employees and shareholders of F. Hoffmann-La Roche Ltd. S.W.A., K.C.H., M.A.M., J.R.S. and R.Y. are employees and shareholders of Eli Lilly and Company. R.J.B. is Director of DIAN–TU and Principal Investigator of DIAN–TU-001. He receives research support from the NIA of the NIH, DIAN–TU trial pharmaceutical partners (Eli Lilly and Company, F. Hoffman-La Roche Ltd and Avid Radiopharmaceuticals), Alzheimer’s Association, GHR Foundation, Anonymous Organization, DIAN–TU Pharma Consortium (active: Biogen, Eisai, Eli Lilly and Company, Janssen, F. Hoffmann-La Roche Ltd/Genentech; previous: AbbVie, Amgen, AstraZeneca, Forum, Mithridion, Novartis, Pfizer, Sanofi, United Neuroscience). He has been an invited speaker and consultant for AC Immune, F. Hoffman-La Roche Ltd and Janssen and a consultant for Amgen and Eisai. D.H., the Department Head of Neurology where the research is being conducted, is an inventor on patents for solanezumab, currently being tested in the DIAN–TU clinical trials. If solanezumab is approved as a treatment for AD or dominantly inherited AD, Washington University and D.H. will receive part of the net sales of solanezumab from Eli Lilly and Company, which has licensed patents related to solanezumab from Washington University. The funders of the study had no role in the collection, analysis or interpretation of the data, the writing of the report or in the decision to submit the paper for publication. S.B.B., S.M.B., W.S.B., K.A.C., D.H., B.A.G., J.J.L., J.J.L.G., M. Formaglio, S.J., R.C., Y.L., R.K., I.Z.J.V., S.L.M., G.M.S., C.X., D.W. and J.R.B. do not declare any competing interests.