Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers (ECL-Lecanemab)

Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers

This study aims to evaluate the therapeutic efficacy of Lecanemab in patients with Alzheimer's disease. The researchers will use a novel detection method based on mesoporous gold electrode surface-enhanced electrochemiluminescence (ECL) to monitor specific biomarkers in the patients' plasma. By tracking changes in these biomarkers, the study seeks to determine how effectively Lecanemab treats the disease and to validate this new ECL-based monitoring system as a useful tool for clinical assessment.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Lecanemab

Detailed Description

Background:

Lecanemab is an antibody used for the treatment of Alzheimer's disease (AD). Monitoring its therapeutic efficacy accurately is crucial for patient management. Traditional methods can be complex or less sensitive. This study introduces a highly sensitive electrochemiluminescence (ECL) assay using mesoporous gold electrodes to detect AD-related plasma biomarkers.

Study Design:

This is an observational/clinical study involving patients diagnosed with Alzheimer's disease who are receiving Lecanemab treatment.

Methodology:

Blood samples will be collected from participants at scheduled visits. The levels of specific AD biomarkers in the plasma will be measured using the developed mesoporous gold electrode ECL system. These measurements will be correlated with clinical outcomes to assess the drug's efficacy. The study also aims to establish the reliability and sensitivity of this specific ECL technique for routine clinical monitoring.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xuhua Xu; Phone Number: +8613705790560; Email: fupinglangying@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Xuhua Xu; Phone Number: +86 13705790560; Email: fupinglangying@zju.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia.
2. Age between 50 and 90 years (inclusive).
3. Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers).
4. Mini-Mental State Examination (MMSE) score between 22 and 30.
5. Clinical Dementia Rating (CDR) global score of 0.5 or 1.
6. Stable dose of allowed concomitant medications for at least 4 weeks prior to screening.
7. Willing and able to comply with the study procedures, including blood draws for ECL monitoring.
8. Signed informed consent form.

Exclusion Criteria:

1. Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).
2. History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.
3. Use of anticoagulants that cannot be safely interrupted.
4. Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.
5. Known hypersensitivity to Lecanemab or any excipients.
6. Pregnant or breastfeeding women.
7. Participation in another interventional clinical trial within the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Lecanemab Treatment Group; Participants in this arm will receive Lecanemab treatment according to the standard clinical protocol for Alzheimer's disease. Their plasma biomarkers will be monitored using the mesoporous gold electrode ECL system to evaluate therapeutic efficacy.	Drug: Lecanemab; Participants will receive Lecanemab (10 mg/kg) via intravenous infusion every two weeks for a total of 18 months. The dosage and frequency follow the standard prescribing information for Alzheimer's disease treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plasma Alzheimer's Biomarkers	The concentration of specific biomarkers (e.g., Aβ42, p-Tau181) in plasma will be measured using the mesoporous gold electrode ECL system. The change from baseline to the end of treatment will be calculated to evaluate therapeutic efficacy.	Baseline and every 4 weeks during the 18-month treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CDR-SB Score	Cognitive function will be assessed using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Scores range from 0 to 18, with higher scores indicating greater impairment. Change from baseline will be analyzed.	Baseline, Month 6, Month 12, and Month 18

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 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: KY-2026-002

Drug and device information, study documents

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