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Clinical Trials in China / NCT07688460
Recruiting Phase 4

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

NCT07688460 · tracked via the Priya Life Science China tracker
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Phase
Phase 4
Started
2026-07-10
Last updated
2026-07-07

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

Lecanemab →

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Plasma Alzheimer's Biomarkers — Baseline and every 4 weeks during the 18-month treatment period
    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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University School of Medicine Yiwu Zhejiang Recruiting

On this site

📄 Leqembi (lecanemab) drug profile →

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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 NCT07688460 on ClinicalTrials.gov ↗ ← All trials in China