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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Plasma Alzheimer's Biomarkers
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Clinical Dementia Rating (CDR) global score of 0.5 or
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Plasma Alzheimer's Biomarkers
时间窗: Baseline and every 4 weeks during the 18-month treatment period
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.
次要结局
- Change in CDR-SB Score(Baseline, Month 6, Month 12, and Month 18)