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

Официальное название

Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers

Обзор

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.

Подробное описание

Background:

Lecanemab is an antibody used for the treatment of Alzheimer's disease (AD). Monitoring its therapeutic efficacy accurately is crucial for patient management. Traditional methods can be complex or less sensitive. This study introduces a highly sensitive electrochemiluminescence (ECL) assay using mesoporous gold electrodes to detect AD-related plasma biomarkers.

Study Design:

This is an observational/clinical study involving patients diagnosed with Alzheimer's disease who are receiving Lecanemab treatment.

Methodology:

Blood samples will be collected from participants at scheduled visits. The levels of specific AD biomarkers in the plasma will be measured using the developed mesoporous gold electrode ECL system. These measurements will be correlated with clinical outcomes to assess the drug's efficacy. The study also aims to establish the reliability and sensitivity of this specific ECL technique for routine clinical monitoring.

Вмешательства

• Препарат Lecanemab
  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.

Первичные конечные точки

• Change in Plasma Alzheimer's Biomarkers [Срок оценки: Baseline and every 4 weeks during the 18-month treatment period]

Вторичные конечные точки (1)

• Change in CDR-SB Score [Срок оценки: Baseline, Month 6, Month 12, and Month 18]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07688460 · KY-2026-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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