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

NCT07688460 | Recruiting Phase 4

• 1 other identifier: KY-2026-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in Plasma Alzheimer's Biomarkers

  The concentration of specific biomarkers (e.g., Aβ42, p-Tau181) in plasma will be measured using the mesoporous gold electrode ECL system. The change from baseline to the end of treatment will be calculated to evaluate therapeutic efficacy.

  Baseline and every 4 weeks during the 18-month treatment period

Secondary Outcomes (1)

• Change in CDR-SB Score

  Baseline, Month 6, Month 12, and Month 18

Study Arms (1)

Experimental: Lecanemab Treatment Group

EXPERIMENTAL

Participants in this arm will receive Lecanemab treatment according to the standard clinical protocol for Alzheimer's disease. Their plasma biomarkers will be monitored using the mesoporous gold electrode ECL system to evaluate therapeutic efficacy.

Drug: Lecanemab

Interventions

Lecanemab DRUG

Participants will receive Lecanemab (10 mg/kg) via intravenous infusion every two weeks for a total of 18 months. The dosage and frequency follow the standard prescribing information for Alzheimer's disease treatment.

Experimental: Lecanemab Treatment Group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Xuhua Xu

CONTACT

+8613705790560; fupinglangying@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label study designed to evaluate the efficacy of Lecanemab in treating Alzheimer's disease and to validate a novel ECL-based monitoring system. All participants will receive the standard Lecanemab treatment regimen.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 7, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

CN (1)