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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. ;


Study Design


Related Conditions & MeSH terms


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

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