NCT07688460RecruitingPhase 4
Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers
Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- 10 Jul 2026
- Primary completion date
- 30 Mar 2029
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Diseases
- Alzheimer disease
- NCT number
- NCT07688460
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 10 Jul 2026 to the primary completion date, 30 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).
- History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.
- Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.
- Known hypersensitivity to Lecanemab or any excipients.
Other
- Use of anticoagulants that cannot be safely interrupted.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial within the last 30 days.
Who the study is looking for
- 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.
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Yiwu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.