Understanding Patient Characteristics of Phase 3 APOLLOE4 Trial of ALZ-801 in Alzheimer Disease: John Hey, PhD

WATCH TIME: 3 minutes

"The reason why we’re so well suited for that population is that ALZ-801 does not interact at all with plaque, it’s working upstream, and it prevents the formulation of the species of oligomer that are injurious and also get deposited into the insoluble fraction."

At the 2023 American Academy of Neurology (AAN) Annual Meeting, held April 22-27, in Boston, Massachusetts, Alzheon, a clinical-stage biopharmaceutical company, presented baseline imaging characteristics from its ongoing phase 3 APOLLOE4 clinical trial (NCT04770220) and 12-month results from its phase 2 biomarker study (NCT04693520) assessing its investigational agent ALZ-801. Supported by a $47 million grant from the National Institute on Aging, APOLLOE4 will assess the effects of 265 mg twice daily oral dose of ALZ-801 in patients with early-stage Alzheimer disease (AD) with the apolipoprotein e4/4 genotype, who constitute 15% of all cases of AD.

ALZ-801 acts through a novel enveloping molecular mechanism of action to fully block formation of neurotoxic soluble amyloid oligomers in the human brain associated with the onset of cognitive symptoms and progression of AD. APOLLOE4, a 78-week trial, will use change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13, phosphorylated tau (p-tau)181 levels, and hippocampal volume, as part of the primary outcome measures. In the early imaging findings, the patient population exhibited a high rate of cerebral amyloid angiopathy (CAA)-related lesions at baseline, making them more susceptible to treatment-induced amyloid-related imaging abnormalities (ARIA) of brain edema and microhemorrhage.

At the meeting, NeurologyLive® sat down with John Hey, PhD, chief scientific officer at Alzheon, to gain a better understanding of the characteristics for the APOLLOE4 cohort. Hey provided commentary on the high levels of CAA-related lesions, and why ALZ-801 may be more suitable to this patient population.

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REFERENCE
1. Alzheon to present baseline imaging characteristics from ongoing APOLLOE4 phase 3 trial of oral tablet ALZ-801 (Valiltramiprosate) and results of phase 2 biomarker study at American Academy of Neurology Conference in Boston. News release. Alzheon. April 18, 2023. Accessed May 9, 2023. https://www.businesswire.com/news/home/20230418005109/en/Alzheon-to-Present-Baseline-Imaging-Characteristics-from-Ongoing-APOLLOE4-Phase-3-Trial-of-Oral-Tablet-ALZ-801-Valiltramiprosate-and-Results-of-Phase-2-Biomarker-Study-at-American-Academy-of-Neurology-Conference-in-Boston