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

Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study ID
NCT07688460
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Lecanemab — DRUG
    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 Details

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.

Key Dates

First listed
Jul 7, 2026
Start date
Jul 10, 2026
Status verified
Jul 2026
Primary completion
Mar 30, 2029
Completion
Mar 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Plasma Alzheimer's Biomarkers [ Time Frame: Baseline and every 4 weeks during the 18-month treatment period ]

Central Contacts

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