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.
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.
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.
Single group
Lecanemab
DrugParticipants 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.
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.
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.
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