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Authors
Chen, Charles D.
Franklin, Erin E.
Li, Yan
Joseph-Mathurin, Nelly
Burns, Aime L.
Hobbs, Diana A.
McCullough, Austin A.
Schultz, Stephanie A.
Xiong, Chengjie
Wang, Guoqiao
Masellis, Mario
Hsiung, Ging-Yuek Robin
Gauthier, Serge
Berman, Sarah B.
Roberson, Erik D.
Honig, Lawrence S.
Clarnette, Roger
Ringman, John M.
Galvin, James E.
Brooks, William
Suzuki, Kazushi
Black, Sandra
Levin, Johannes
Aggarwal, Neelum T.
Jucker, Mathias
Frosch, Matthew P.
Kofler, Julia K.
White, Charles III
Keene, C. Dirk
Chen, Jie
Daniels, Alisha
Gordon, Brian A.
Ibanez, Laura
Karch, Celeste M.
Llibre-Guerra, Jorge
McDade, Eric
Morris, John C.
Supnet-Bell, Charlene
Allegri, Ricardo F.
Lee, Jae-Hong
Day, Gregory S.
Lopera, Francisco
Roh, Jee Hoon
Schofield, Peter R.
Mills, Susan
Benzinger, Tammie L. S.
Bateman, Randall J.
Perrin, Richard J.
,
,
Bateman, Randall
Daniels, Alisha J.
Courtney, Laura
Llibre-Guerra, Jorge J.
Xiong, Chengie
Xu, Xiong
Lu, Ruijin
Gremminger, Emily
Jerome, Gina
Herries, Elizabeth
Stauber, Jennifer
Baker, Bryce
Minton, Matthew
Cruchaga, Carlos
Goate, Alison M.
Renton, Alan E.
Picarello, Danielle M.
Benzinger, Tammie
Hornbeck, Russell
Hassenstab, Jason
Smith, Jennifer
Stout, Sarah
Aschenbrenner, Andrew J.
Marsh, Jacob
Holtzman, David M.
Barthelemy, Nicolas
Xu, Jinbin
Noble, James M.
Ikonomovic, Snezana
Nadkarni, Neelesh K.
Graff-Radford, Neill R.
Farlow, Martin
Chhatwal, Jasmeer P.
Ikeuchi, Takeshi
Kasuga, Kensaku
Niimi, Yoshiki
Huey, Edward D.
Salloway, Stephen
Brooks, William S.
Bechara, Jacob A.
Martins, Ralph
Fox, Nick C.
Cash, David M.
Ryan, Natalie S.
Laske, Christoph
Hofmann, Anna
Kuder-Buletta, Elke
Graber-Sultan, Susanne
Obermueller, Ulrike
Roedenbeck, Yvonne
Vӧglein, Jonathan
Sanchez-Valle, Raquel
Rosa-Neto, Pedro
Mendez, Patricio Chrem
Surace, Ezequiel
Vazquez, Silvia
Leon, Yudy Milena
Ramirez, Laura
Aguillon, David
Levey, Allan I.
Johnson, Erik C. B.
Seyfried, Nicholas T.
Ringman, John
Fagan, Anne M.
Mori, Hiroshi
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Funding
Funding for this research was provided by:
National Institutes of Health (U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438, U19AG032438)
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Article History
Received: 24 February 2025
Revised: 22 April 2025
Accepted: 9 May 2025
First Online: 3 June 2025
Declarations
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: Washington University holds patents for one of the treatments (solanezumab), previously tested in the DIAN clinical trials. If solanezumab is approved as a treatment for Alzheimer’s disease or Dominantly Inherited Alzheimer’s Disease, Washington University will receive part of the net sales of solanezumab from Eli Lilly, which has licensed the patents related to solanezumab from Washington University. Johannes Levin reports speaker fees from Bayer Vital, Biogen, EISAI, TEVA, Zambon, Merck and Roche, consulting fees from Axon Neuroscience, EISAI and Biogen, author fees from Thieme medical publishers and W. Kohlhammer GmbH medical publishers and is inventor in a patent “Oral Phenylbutyrate for Treatment of Human 4-Repeat Tauopathies” (EP 23 156 122.6) filed by LMU Munich. In addition, he reports compensation for serving as chief medical officer for MODAG GmbH, is beneficiary of the phantom share program of MODAG GmbH and is inventor in a patent “Pharmaceutical Composition and Methods of Use” (EP 22 159 408.8) filed by MODAG GmbH, all activities outside the submitted work. Tammie Benzinger, MD, PhD, has received investigator initiated research funding from the NIH, the Alzheimer’s Association, the Foundation at Barnes-Jewish Hospital, Siemens Healthineers and Avid Radiopharmaceuticals (a wholly-owned subsidiary of Eli Lilly and Company). She participates as a site investigator in clinical trials sponsored by Eli Lilly and Company, Biogen, Eisai, Jaansen, and Roche. She has served as a paid and unpaid consultant to Eisai, Siemens, Biogen, Janssen, and Bristol-Myers Squibb. John Morris consults for Barcelonaβeta Brain Research Foundation Scientific Advisory Board and Diverse VCID Observational Study Monitoring Board. He is on the advisory board for Cure Alzheimer’s Fund Research Strategy Council and LEADS Advisory Board, University of Indiana. John Morris is funded by NIH grants # P30 AG066444; P01AG003991; P01AG026276. Neither John Morris nor his family owns stock or has equity interest (outside of mutual funds or other externally directed accounts) in any pharmaceutical or biotechnology company. Sandra Black reports grants or contracts from any entity (Contract Research: Genentech, Optina, Roche, Eli Lilly, Eisa/Biogen Idec, NovoNordisk, Lilly Avid, ICON; Peer Reviewed: Ontario Brain Institute, CIHR, Leducq Foundation, Heart and Stroke Foundation of Canada, NIH, Alzheimer’s Drug Discovery Foundation, Brain Canada, Weston Brain Institute, Canadian Partnership for Stroke Recovery, Canadian Foundation for Innovation, Focused Ultrasound Foundation, Alzheimer’s Association US, Department of National Defence, Montreal Medical International Kuwait, Queen’s University, Compute Canada Resources for Research Groups, CANARIE, Networks of Centres of Excellence of Canada), consulting fees (Roche, Biogen, NovoNordisk, Eisai, Eli Lilly), payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (Biogen, Roche New England Journal Manuscript, Roche Models of Care Analysis in Canada in Submission, Eisai MRI Workshop), and participation on a Data Safety Monitoring Board or Advisory Board (Conference Board of Canada, World Dementia Council, University of Rochester Contribution to the Mission and Scientific Leadership of the Small Vessel VCID Biomarker Validation Consortium, National Institute of Neurological Disorders and Stroke). Lawrence Honig has received funding for consulting from Biogen, Eisai, Genentech/Roche, Medscape, and Prevail/Lilly, and has received institutional research funding from Abbvie, Acumen, Alector, AstraZeneca, Axovant, Avanir, Biogen, Bristol-Myer Squibb, Cognition, EIP, Eisai, Genentech/Roche, Janssen/Johnson & Johnson, Eli Lilly, Merck, Transposon, UCB, and Vaccinex. Richard Perrin’s laboratory receives cost recovery funding from Biogen for tissue procurement and processing services related to ALS clinical trials.
: The study was conducted in accordance with the Declaration of Helsinki (version 7) and the International Conference on Harmonization and Good Clinical Practice guidelines. Protocols for the study have received prior approval by the local Institutional Review Board (IRB) or Ethics Committee of each DIAN site and by the Washington University IRB for the Knight ADRC. The clinical trial registration number is NCT01760005.
