An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects — APOLLOE4  

Early Alzheimer's Disease Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial Summary

This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.

Clinical Trial Description

This is a multi-center, double-blind study that will evaluate 265 mg BID of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). The primary efficacy outcome assessment is a measure of cognition (ADAS-cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Early Alzheimer's Disease

• NCT number: NCT04770220
• Study type: Interventional
• Source: Alzheon Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 19, 2021
• Completion date: June 30, 2024