NCT06862960

Ozanimod in Patients With Alzheimer's Disease

Ozanimod for the Treatment of Alzheimer's Disease: a Proof-of-concept Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: ChenXiaoChun · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the benefits of ozanimod in patients with moderate Alzheimer's disease.

Detailed description

This study will enroll 40 patients with moderate Alzheimer's disease (AD), who will be divided into two groups according to a fixed 1:1 (ozanimod : control) schedule. Patients in control group will receive ongoing approved AD treatment (eg, acetylcholinesterase inhibitors, memantine, or both), while those in the ozanimod group will receive the same approved AD treatment with the addition of ozanimod. The treatment will be for 27 weeks. All participants will undergo assessments at baseline and week 27, including 18F-florbetaben PET imaging, blood tests, and cognitive evaluations.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Ozanimod	A sphingosine-1-phosphate receptor regulator
DRUG	Conventional medication	Conventional medications for moderate AD

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-06-30
• Completion: 2027-12-30
• First posted: 2025-03-07
• Last updated: 2025-07-01