Testing the Safety and Preliminary Efficacy of the New Drug ORY-2001 in Mild to Moderate Alzheimer's Disease
NCT03867253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2021-03-05
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.
Conditions
- Mild to Moderate Alzheimer's Disease
Interventions
- DRUG
-
ORY-2001 Low dose
0.6mg ORY-2001 capsule
- DRUG
-
ORY-2001 High dose
1.2mg ORY-2001 capsule
- DRUG
-
Placebo capsule
Sponsors & Collaborators
-
Alzheimer's Drug Discovery Foundation
collaborator OTHER -
Oryzon Genomics S.A.
lead INDUSTRY
Principal Investigators
-
Michael Ropacki, MD · Oryzon Genomics S.A.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-16
- Primary Completion
- 2020-11-12
- Completion
- 2020-11-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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