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Article History

Received: 10 November 2025

Accepted: 23 November 2025

First Online: 1 December 2025

Declarations

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: Not applicable.

: Not Applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: All Alzheon employees receive salary compensation and stocks and/or stock options from Alzheon Inc. The AD experts (Drs. M. Doraiswamy, D. Tosun, A. Porsteinsson, M. Sabbagh, and S. Gauthier) received consulting fees and/or stock options from Alzheon Inc., and multiple other pharmaceutical companies developing central nervous system (CNS) drugs/devices/diagnostic tests; or served on the Alzheon Scientific Advisory Board with stock option compensation. Dr. Doraiswamy has also received grants from several pharmaceutical companies and serves on the boards of health systems and NGOs. Dr. Barkhof received consulting fees from several pharmaceutical companies developing AD treatments and from neuroimaging companies. The clinical trial investigators (Drs. D. Watson, E. MacSweeney, S. Cohen, and M. Boada) received investigator fees for one or all of the cited anti-amyloid drug trials, and for other AD and CNS trials from various global pharmaceutical companies. Dr. J. Barakos consults for Clario Inc., which provides imaging services to Alzheon Inc. and other AD drug trials. Dr. S. Hendrix and S. Dickson and Mr. A. Durrant are employees of Pentara Inc., which provided statistical services, and receive compensation from Alzheon Inc. and other AD trial sponsors. Drs. Petrella and Ritchie do not report any conflicts of interest.

: Alzheon Employees: S. Abushakra, J. Hey, P. Kesslak, E. Liang, A. Power, R. McLaine, J. Schaefer. S. Flint, J. Yu, A. Albayrak, M. Brey, and M. Tolar all contributed to the conceptual framework of this paper and to one or more of the following: literature search and summaries, providing data analyses, interpretation, writing, and reviewing or editing the manuscript. S. Abushakra is the principal investigator on the US National Institute of Aging (NIA) grant for the APOLLOE4 trial. Co-authors: P.M. Doraiswamy advised on the design, literature reviews, interpretation, and manuscript editing. D. Tosun contributed to the design and review of MRI and DTI studies and their interpretation. All other co-authors contributed to review of literature, interpretation of studies, and manuscript writing and reviews. D. Watson, E. McSweeney, S. Cohen, and M. Boada were investigators for AD trials (including ALZ-801-AD301) in the USA, UK, Canada, and Europe, respectively; they contributed to data interpretation and manuscript reviews. S. Hendrix, S. Dickson, and A. Durrant contributed to the statistical methods and antibody trial group-level analysis. Drs J. Petrella, J. Barakos, C. Ritchie, and S. Gauthier contributed to technical vMRI details, data review and interpretation, and review of the manuscript. All authors have reviewed and approved the final manuscript and agree to be accountable for this work.