Hey, John A. http://orcid.org/0000-0002-5104-6231
Abushakra, Susan
Blennow, Kaj
Reiman, Eric M.
Hort, Jakub
Prins, Niels D.
Sheardova, Katerina
Kesslak, Patrick
Shen, Larry
Zhu, Xinyi
Albayrak, Adem
Paul, Jijo
Schaefer, Jean F.
Power, Aidan
Tolar, Martin
Article History
Accepted: 14 June 2024
First Online: 20 June 2024
Declarations
:
: This research was funded by Alzheon, Inc.
: J.A.H., S.A.S., P.K., A.A., J.P., J.F.S., A.P., and M.T. are employees of Alzheon Inc. and hold stocks or stock options in Alzheon Inc. L.S. and X.Z. are employees of Wuxi Apptec that provides statistical contracting services to Alzheon Inc. K.B., E.M.R., J.H., and K.S. are scientific advisors to Alzheon Inc. and hold stocks or stock options in Alzheon Inc. N.D.P. is an investigator in the phase 2 and phase 3 studies of ALZ-801.
: The protocol was approved by the assigned ethics committees (EC) in the Netherlands and in Czech Republic and by some institutional EC in the Czech Republic.
: All subjects and their partners, caregivers, or legal representatives signed informed consent before participation in the study.
: Not applicable.
: ADNI datasets are publicly available at the website http//ADNI.LONI.USC.edu. The ALZ-801 data are proprietary to Alzheon Inc.
: Not applicable.
: J.A.H., S.A.S., and A.P. created the study concept and design; K.B., E.M.R., J.H., and K.S. provided advice on study design or biomarker selection; S.A.S., P.K., J.A.H., A.P., J.P., and L.S. wrote the protocol; S.A.S. and J.A.H. selected the study sites and oversaw the study conduct; N.D.P. provided oversight of study enrollment and conduct; S.A.S. and P.K. oversaw subject safety; J.A.H., J.P., and J.F.S. oversaw the laboratory and biomarker sample workstream and drug supply; S.A.S. and J.A.H. wrote the manuscript; S.A.S., J.A.H., A.P., P.K., A.A., P.K., J.F.S., L.S., X.Z., and M.T. reviewed the manuscript and provided substantial edits. All authors have read and approve the final submitted manuscript and agree to be accountable for the work