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Article History

Received: 2 September 2025

Accepted: 23 September 2025

First Online: 28 September 2025

Declarations

:

: Alzheon employees receive salary compensation and stocks and/or stock options from Alzheon Inc. The AD experts (A. Porsteinsson, M. Sabbagh, M. Doraiswamy) received consulting fees and stocks or stock options from Alzheon Inc, and multiple other pharmaceutical companies developing CNS drugs, devices, or diagnostic tests. The site investigators (D. Watson, E. MacSweeney, S. Cohen, M. Boada-Rivera) received investigator fees for this study and multiple other AD and CNS trials from various global pharmaceutical companies. S. Dickinson is an employee of Pentara Inc., which provided statistical services and receives compensation from Alzheon Inc.

: The data that support the findings of this study are available from Alzheon, Inc., but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are, however, available from the authors upon reasonable request and with permission of Alzheon, Inc.

: The APOLLOE4 trial was approved by Adverra Central IRB and by the required local university IRBs in the US, and by country-specific ethics committees in the UK and EU. Alzheon certifies that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

: All participants signed written informed consent to participate in the trial before screening.

: Not applicable.

: Not applicable.

: Alzheon employees: S. Abushakra is the principal investigator on the NIA grant for the APOLLOE4 trial. S. Abushakra, A. Power, E. Liang, S. Flint, J., L. Tolar, Hey and M. Tolar designed the trial and oversaw its conduct, data analysis, data interpretation, and manuscript preparation. All other Alzheon employees contributed to one or more of the following: trial conduct and oversight, safety oversight, and data analysis and interpretation. Advisors: A. Porsteinsson and M. Sabbagh were advisors for clinical trial design, data interpretation and manuscript preparation and/or review. P.M. Doraiswamy was scientific advisor and provided manuscript reviews and critiques. D. Watson, E. McSweeney, S. Cohen, and M. Boada-Rivera were trial investigators in the United States, United Kingdom, Canada, and Europe, respectively; they contributed to the trial conduct, safety discussions, data interpretation and manuscript preparation. S. Dickson contributed to statistical methods and data analysis.