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
The purpose of this study is to investigate the benefits of ozanimod in patients with moderate Alzheimer's disease.
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.
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.
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Exclusion Criteria:
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.
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
Patients will receive ongoing approved AD treatment (eg, acetylcholinesterase inhibitors, memantine, or both).
Drug: Conventional medication
A sphingosine-1-phosphate receptor regulator
Conventional medications for moderate AD
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
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
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.
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