Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers
Recruiting · NCT07688460 · Interventional (participants receive a specific treatment) · Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
50 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Clinical Dementia Rating (CDR) global score of 0.5 or 1.
- Stable dose of allowed concomitant medications for at least 4 weeks prior to screening.
- Willing and able to comply with the study procedures, including blood draws for ECL monitoring.
- Signed informed consent form.
Exclusion criteria
- 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.
- Known hypersensitivity to Lecanemab or any excipients.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial within the last 30 days.
Where it is running
1 location listed.
- The First Affiliated Hospital, Zhejiang University School of Medicine - Yiwu, Zhejiang, China