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Article History

Received: 21 July 2026

Accepted: 24 August 2026

First Online: 1 September 2026

Declarations

Ethics Approval: The APOLLOE4 trial was approved by Advarra Central IRB and by the required local university IRBs in the USA, and by country specific Ethics Committees in UK and EU. 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. The Phase 2 study protocol was approved by the ethics committees (EC) in the Netherlands and in Czech Republic. The study was conducted in accordance with the International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP) and applicable local regulatory requirements.

Consent to Participate: All Phase 3 study subjects and their partners, caregivers, or legal representatives signed informed consent before participation in the trial. The Phase 2 study and informed consents were also approved by the Independent Ethics Committee at each study center, and all patients and/or their legal representatives and study partners provided written informed consent.

Consent for Publication: Not applicable.

Code Availability: Not applicable.

Data Availability: The data supporting 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 corresponding authors upon reasonable request and with permission of Alzheon, Inc.

Conflict of interest: JA Hey, S Abushakra, A Power, E Ling, S Flint, E Hristova, P Kesslak, R McLaine, A Albayrak, JF Schaefer, JY Yu, L Tolar, and M Tolar are employees of Alzheon Inc., who received salary compensations, stocks and/or stock options from Alzheon Inc. The AD experts (A Porsteinsson, M Sabbagh, PM Doraiswamy, FM Elahi and RA Rissman) received consulting fees, stocks, and/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 and M Boada) received investigator fees for this study and multiple other AD and CNS trials from various global pharmaceutical companies.

Author Contributions: JA Hey, JY Yu, and L Tolar contributed to manuscript preparation. S Abushakra is the principal investigator of the NIH/NIA grant for the APOLLOE4 trial. S Abushakra, A Power, E Liang, S Flint, JA 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, sample analyses, data analyses, and data interpretation. A Porsteinsson, M Sabbagh, PM Doraiswamy, FM Elahi, and RA Rissman were scientific advisors to Alzheon Inc. who contributed to the study design, data analysis, data interpretation, and critical review of the manuscript. D Watson, E McSweeney, S Cohen, and M Boada were trial investigators in the USA, UK, Canada, and Europe, respectively; they contributed to the trial conduct, safety discussions, data interpretation and manuscript review. All authors reviewed and approved the final submitted version of the manuscript.