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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-90
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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 criteria

Qualifiers

Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia.

Age between 50 and 90 years (inclusive).

Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers).

Mini-Mental State Examination (MMSE) score between 22 and 30.

Disqualifiers

Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).

History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.

Use of anticoagulants that cannot be safely interrupted.

Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.

Trial design

Treatments tested in this trial

  • Lecanemab

Treatment groups

100 Participants
are divided into 1 treatment group