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

Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Dementia (AD); MCI-AD, Early Stage Alzheimer's Disease; Alzheimer s Disease
• Intervention / Treatment: Drug: Conventional anti-dementia treatment group; Drug: Lecanemab 10 mg/kg

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhen Wang, M.D.; Phone Number: +8613858868961; Email: wangzhen@wzhospital.cn

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • First Affiliated Hospital of Wenzhou Medical University
      • Contact: First Affiliated Hospital of Wenzhou Medical University; Phone Number: +8613858868961; Email: wyyy@wzhospital.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).
• There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.
• Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.
• Surgical operations under general anesthesia are planned to be performed during the research period.
• Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lecanemab treatment group	Drug: Lecanemab 10 mg/kg; Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg.
Active Comparator: Conventional anti-dementia treatment	Drug: Conventional anti-dementia treatment group; Conventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aβ-PET centiloid values	Change in Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores in 18 months	baseline, 12 month, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of retinal and cerbral imaging	Retinal and cerbral imaging Difference Between Lecanemab and Conventional Anti-Dementia Treatment Groups	baseline, 6 month, 12 month
Change of MoCA score	Assess the difference in MoCA Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups	baseline, 6 month, 12 month, 18 months
Change of MMSE score	Assess the difference in MMSE Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups	baseline, 6 month, 12 month, 18 months
Change of CDR score	Assess the difference in CDR Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups	baseline, 6 month, 12 month, 18 months
Change of structural MRI	3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)	baseline, 6 month, 12 month, 18 month
Change of functional MRI	Blood oxygenation level dependent (BOLD) imaging	baseline, 6 month, 12 month, 18 month

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; lecanemab
• Other Study ID Numbers: KY2025-355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No