NCT07688460 · Phase 4 · RECRUITING
Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers
This Phase 4 trial gives lecanemab — an already-approved anti-amyloid antibody drug — to people with early Alzheimer's or MCI, then uses a new blood-test technology called ECL to track brain biomarkers in their plasma. The goal is not to re-prove the drug works but to validate this new monitoring tool as a way to measure how well lecanemab is doing its job. Phase 4 means the drug is already approved; this is post-market study work.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-07