Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-27 @ 1:36 PM
Study NCT ID:
NCT06862960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ozanimod in Patients With Alzheimer's Disease
Sponsor:
ChenXiaoChun
Organization:
Study Overview
Official Title:
Ozanimod for the Treatment of Alzheimer's Disease: a Proof-of-concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: