RecruitingPhase 4

Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

China200 participantsStarted 2026-01-01

Plain-language summary

This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment. The primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 50 to 90 years old. * No gender restrictions. * Patients with MCI and mild AD. * The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point. * Positive Amyloid protein confirmed by amyloid-PET or CSF. * There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial. * Agree to participate in the research and sign the informed consent form. Exclusion Criteria: * Patients with cognitive impairment caused by reasons other than AD. * There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening. * A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects. * Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study. * There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment. * There are contraindications for MRI scans, including the installa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Aβ-PET centiloid values

Timeframe: baseline, 12 month, 18 months

Trial details

NCT IDNCT07604896

SponsorFirst Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Zhen Wang, M.D.

+8613858868961 wangzhen@wzhospital.cn

View on ClinicalTrials.gov More Alzheimer s Disease trials