Trial conduct
CIM, Alzheimer’s disease
ATHENEA was a 48-week, phase 2–3, randomized, double-blind, parallel, multicenter, adaptive, placebo-controlled trial with participants screened in Havana Cuba from September, 2017 to September, 2020. The responsible investigator or the site coordinator in each clinical site enrolled the participants.All patients had the opportunity to drop-out of research. The sponsor CIM designed the trial and analyzed the data in collaboration with the academic authors, provided neuroEPO plus and placebo and aided in drafting the manuscript. Confidentiality agreements were in place between the sponsor and the authors and site investigators. CIM provided partial funding for the trial.An independent data and safety monitoring board, consisting of experts in Alzheimer’s disease, clinical trial, and statistics, provided trial oversight. Clinical assessment raters were unaware of the trial-group assignments. All the authors vouch for the completeness and accuracy of the data, the fidelity of the trial to the protocol (available at Data were blindly gathered by the study investigators, blindly analyzed by the sponsor, and interpreted by the sponsors in collaboration with the researchers once the randomization was opened.