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Clinical Trials in China / NCT06862960
Recruiting Phase 2

Ozanimod in Patients With Alzheimer's Disease

NCT06862960 · tracked via the Priya Life Science China tracker
Sponsor
ChenXiaoChun
Phase
Phase 2
Started
2025-08-13
Last updated
2026-07-27

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

Ozanimod →Conventional medication

Ozanimod: A sphingosine-1-phosphate receptor regulator

Conventional medication: Conventional medications for moderate AD

Study summary

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

Eligibility

Sex
ALL
Min age
55 Years
Max age
80 Years
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: 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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06862960 on ClinicalTrials.gov ↗ ← All trials in China