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RecruitingNCT06862960Updated Jul 27, 2026

Ozanimod in Patients With Alzheimer's Disease

A Phase 2 interventional study of Ozanimod and Conventional medication in Alzheimer Disease, sponsored by ChenXiaoChun. Recruiting at 1 site in China. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by ChenXiaoChun · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
55 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Alzheimer Disease

Keywords

  • Alzheimer Disease
  • Ozanimod
  • sphingosine-1-phosphate receptor
  • cognitive dysfunction
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with ChenXiaoChun as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Must meet the 2024 diagnostic criteria for Alzheimer's disease (AD) published by the Alzheimer's Association (AA), and be in the moderate stage of AD.
  2. The Clinical Dementia Rating-Sum of Boxes (CDR-SB) score must be between 9.5 and 15.5.
  3. Aged 55-80 years.
  4. Must be receiving treatment with stable doses of acetylcholinesterase inhibitors, memantine, or both for at least 3 months prior to the screening visit.
  5. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
  6. Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.

Exclusion criteria

Exclusion Criteria:

  1. Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically.
  2. Contraindications to MRI (e.g., metal implants) or inability to tolerate/comply with the scanning procedure.
  3. Prior exposure to ozanimod or any other sphingosine-1-phosphate receptor regulators for AD before starting treatment with ozanimod subject of this study
  4. Participants must not have clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, infectious diseases, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator.
  5. Specific cardiac conditions are excluded, including history or presence of:

    i) Recent (within the past 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, New York Heart Association (NYHA) Class III/IV heart failure, or severe untreated sleep apnea.

    ii) Resting heart rate \<55 beats per minute, second-degree (Mobitz type II) atrioventricular (AV) block, third-degree AV block, sick sinus syndrome, or sino-atrial block unless participants have a pacemaker in place.

    iii) Prolonged corrected QT interval by Fredericia's formula (QTcF; > 450 msec males and > 470 msec females), or participants at additional risk for QT prolongation.

  6. Participants must not receive a live vaccine or a live-attenuated vaccine within 4 weeks prior to first dose or planning to receive a live vaccine or a live-attenuated vaccine during the study or within 90 days after discontinuation from study intervention.
  7. Participants must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Ozanimod Group

    Patients will receive ongoing approved AD treatment (eg, acetylcholinesterase inhibitors, memantine, or both) plus ozanimod. Ozanimod will be administered in strict accordance with the stepwise dose-escalation protocol (Days 1-4: 0.23 mg/day; Days 5-7: 0.46 mg/day), followed by a maintenance dose of 0.92 mg once daily from Day 8. The total treatment duration will be 27 weeks, including both titration and maintenance phases.

    Drug: Ozanimod

  • Active comparator
    Control Group

    Patients will receive ongoing approved AD treatment (eg, acetylcholinesterase inhibitors, memantine, or both).

    Drug: Conventional medication

Interventions

  • DrugOzanimod

    A sphingosine-1-phosphate receptor regulator

  • DrugConventional medication

    Conventional medications for moderate AD

06

What researchers measure

Primary outcomes

  1. Mean Absolute Change From Baseline in Brain Amyloid Plaque on 18F-florbetaben PET Scan on Ozanimod Group Versus Control Group

    18F-florbetaben PET imaging was used as a quantitative amyloid biomarker. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a Centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. A negative change indicates an improvement from baseline.

    Time frame: Baseline to Week 27

  2. Changes in serum GFAP

    We will quantify neuroinflammatory burden through plasma glial fibrillary acidic protein (GFAP) levels, comparing pre- and post-Ozanimod treatment, as well as between the Ozanimod group and the control group. Assessments will be conducted at baseline and week 27.

    Time frame: Baseline to Week 27

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be publicly shared due to the highly sensitive nature of genetic and biomarker profiles. De-identified aggregate data will be available upon reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06862960
Lead sponsor
ChenXiaoChun
Collaborators
Fujian Medical University Union Hospital
Responsible party
ChenXiaoChun (Professor, Fujian Medical University Union Hospital) — Sponsor-investigator
First posted
Mar 7, 2025
Start date
Aug 13, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Jul 27, 2026

Study contacts

Xiaochun Chen
Contact
chenxc998@mail.fjmu.edu.cn
+86 139 0501 6998
Tianwen Huang
Contact
huangtianwen2002@mail.fjmu.edu.cn
+86 133 6591 7869

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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