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Recruiting Phase 4

Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers

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About this study

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.

Condition
Alzheimer Disease
Tested
Lecanemab
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Who can join

Age
50 to 90 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 50 years
  • Maximum age: 90 years
  • Study condition: Alzheimer Disease
  • 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.

Exclusion 7

  • 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.

Where

1 site, 1 recruiting

The First Affiliated Hospital, Zhejiang University School of Medicine

Yiwu, Zhejiang, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.