Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 23 May 2025

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At a glance

10 Apr 2025 According to an Alzheon media release,company announced topline results from the pivotal APOLLOE4 Phase 3 trial of oral valiltramiprosate/ALZ-801 in patients with Early AD comprised of Mild Cognitive Impairment (MCI) and Mild AD dementia, who carry two copies of the allele of the apolipoprotein E gene (APOE4/4 homozygotes)
10 Apr 2025 According to an Alzheon media release,Primary endpoint (Primary cognitive efficacy endpoint) has not been met.
10 Apr 2025 Results published in the Alzheon media release

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