Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers (NCT07688460) | Clinical Trial Compass
RecruitingPhase 4
Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers
China100 participantsStarted 2026-07-10
Plain-language 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.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Plasma Alzheimer's Biomarkers
Timeframe: Baseline and every 4 weeks during the 18-month treatment period
Trial details
NCT IDNCT07688460
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine