NCT03867253

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Oryzon Genomics S.A. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mild to Moderate Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ORY-2001 Low dose	0.6mg ORY-2001 capsule
DRUG	ORY-2001 High dose	1.2mg ORY-2001 capsule
DRUG	Placebo	Placebo capsule

Timeline

• Start date: 2019-05-16
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2019-03-07
• Last updated: 2021-03-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study