Lecanemab Efficacy Monitoring with Gold Electrode ECL in Alzheimer’s

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 study monitors Alzheimer’s patients receiving lecanemab and uses a novel mesoporous gold electrode electrochemiluminescence assay to measure plasma biomarkers. Blood samples are taken at set visits to correlate biomarker changes with clinical outcomes, aiming to validate the ECL method for routine monitoring. The design is observational with an intervention (lecanemab) to assess treatment efficacy alongside the biomarker assay. Eligibility focuses on adults with mild cognitive impairment due to AD or mild Alzheimer’s dementia who have confirmed amyloid pathology and stable comedications. The trial is conducted at a Zhejiang University-affiliated hospital in China, led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Yiwu, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xuhua Xu
• Email: fupinglangying@zju.edu.cn
• Phone: +8613705790560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.