NCT07688460 Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers
| NCT ID | NCT07688460 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2026-07-10 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia. 2. Age between 50 and 90 years (inclusive). 3. Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers). 4. Mini-Mental State Examination (MMSE) score between 22 and 30. 5. Clinical Dementia Rating (CDR) global score of 0.5 or 1. 6. Stable dose of allowed concomitant medications for at least 4 weeks prior to screening. 7. Willing and able to comply with the study procedures, including blood draws for ECL monitoring. 8. Signed informed consent form. Exclusion Criteria: 1. Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease). 2. History of brain hemorrhage, microbleeds, or superficial siderosis on MRI. 3. Use of anticoagulants that cannot be safely interrupted. 4. Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study. 5. Known hypersensitivity to Lecanemab or any excipients. 6. Pregnant or breastfeeding women. 7. Participation in another interventional clinical trial within the last 30 days.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07688460 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07688460 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07688460 currently recruiting?
Yes, NCT07688460 is actively recruiting participants. Contact the research team at fupinglangying@zju.edu.cn for enrollment information.
Where is the NCT07688460 trial being conducted?
This trial is being conducted at Yiwu, China.
Who is sponsoring the NCT07688460 clinical trial?
NCT07688460 is sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.