Alzheon, Inc. announced the publication of a peer-reviewed research paper, “Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression,” in the Special Issue Alzheimer’s Disease: Role and Structure of Soluble Oligomers of the International Journal of Molecular Sciences. The publication provides an up-to-date summary of longitudinal clinical data elucidating the chronology of amyloid and tau biomarkers in AD, and review of non-clinical studies and clinical trials supporting the upstream pathogenic role of amyloid oligomers in AD. In summary, the authors: Present analyses showing that only agents that target soluble amyloid oligomers show clinical efficacy in AD patients, while agents that predominantly target amyloid monomers or plaque failed to demonstrate clinical effects. Analyze data on clearance of amyloid plaques in amyloid antibody trials showing that even complete plaque removal does not correlate with clinical efficacy. Explain why in positive trials, clinical efficacy is greater in carriers of the e4 allele of apolipoprotein E gene (APOE4), who are known to have a higher burden of amyloid oligomers in the brain. Review data from recent positive trials, where inhibition of amyloid neurotoxicity leads to a reduction in tau pathology, showing that amyloid toxicity drives increased tau phosphorylation and tau deposition in neurofibrillary tangles. The review highlights the superior selectivity of ALZ-801 for amyloid oligomers and the pioneering precision medicine approach of the APOLLOE4 Phase 3 trial evaluating ALZ-801 tablet in APOE4/4 homozygous AD patients. The FDA’s accelerated approval of Biogen’s anti-amyloid therapy aducanumab (Aduhelm) validates ALZ-801’s mechanism of action and confirms a regulatory path for a clinical study that provides strong biomarker data to support clinical outcomes. Anti-amyloid antibody treatments present logistical challenges since they are administered by intravenous infusions and require serial magnetic resonance imaging scans to monitor for brain edema and hemorrhage, while ALZ-801 is an oral drug with a robust safety profile among AD patients.