Testing the Safety and Preliminary Efficacy of the New Drug ORY-2001 in Mild to Moderate Alzheimer's Disease — ETHERAL-US  

Mild to Moderate Alzheimer's Disease Clinical Trial

Official title: A Multicentre,Randomised, Double-blind, Placebo-controlled, 3-arm, 24-week Parallel-group Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ORY-2001 in Patients With Mild-moderate Alzheimer's Disease

Status Completed

Clinical Trial Summary

This is a Phase IIa study assessing the safety, tolerability and preliminary efficacy of ORY-2001 in mild to moderate Alzheimer's Disease patients.

Clinical Trial Description

This phase IIa study is a double-blind, randomized, parallel-group and multicenter study with a placebo-controlled 24-week treatment period followed by a no placebo-controlled 24-week extension period.

It is planned to randomise 25 patients. In the double-blind placebo-controlled treatment period, all patients will be randomized between two doses of ORY-2001 and placebo. In the double-blind no placebo-controlled extension period, patients in the placebo arm will be re-allocated in one of the two different dose levels of ORY-2001. Randomization will be stratified by cognitive impairment severity.

An independent Data Monitoring Committee (DMC) will review un-blinded safety data throughout the study. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild to Moderate Alzheimer's Disease

• NCT number: NCT03867253
• Study type: Interventional
• Source: Oryzon Genomics S.A.
• Status: Completed
• Phase: Phase 2
• Start date: May 16, 2019
• Completion date: November 12, 2020