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

Phase 4RecruitingNCT07688460

The Fourth Affiliated Hospital of Zhejiang University School of Medicine100 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Alzheimer Disease

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and every 4 weeks during the 18-month treatment period

Secondary Outcomes

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.

Time frame: Baseline, Month 6, Month 12, and Month 18