Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
2026年5月17日 更新者：First Affiliated Hospital of Wenzhou Medical University
Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment.
The primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.
研究概览
研究类型
介入性
注册 (估计的)
200
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhen Wang, M.D.
- 电话号码：+8613858868961
- 邮箱：wangzhen@wzhospital.cn
学习地点
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Zhejiang
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Wenzhou、Zhejiang、中国
- 招聘中
- First Affiliated Hospital of Wenzhou Medical University
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接触：
- First Affiliated Hospital of Wenzhou Medical University
- 电话号码：+8613858868961
- 邮箱：wyyy@wzhospital.cn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age: 50 to 90 years old.
- No gender restrictions.
- Patients with MCI and mild AD.
- The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.
- Positive Amyloid protein confirmed by amyloid-PET or CSF.
- There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.
- Agree to participate in the research and sign the informed consent form.
Exclusion Criteria:
- Patients with cognitive impairment caused by reasons other than AD.
- There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.
- A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.
- Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.
- There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.
- There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).
- There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.
- Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.
- Surgical operations under general anesthesia are planned to be performed during the research period.
- Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Lecanemab treatment group
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Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL.
Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution.
Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter.
The dosage of Lecanemab is 10 mg/kg.
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有源比较器：Conventional anti-dementia treatment
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常规抗痴呆治疗：早期的阿尔茨海默氏病（AD）患者常规服用胆碱酯酶抑制剂（如多奈哌齐）进行治疗。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Aβ-PET centiloid values
大体时间：baseline, 12 month, 18 months
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Change in Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores in 18 months
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baseline, 12 month, 18 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of retinal and cerbral imaging
大体时间：baseline, 6 month, 12 month
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Retinal and cerbral imaging Difference Between Lecanemab and Conventional Anti-Dementia Treatment Groups
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baseline, 6 month, 12 month
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Change of MoCA score
大体时间：baseline, 6 month, 12 month, 18 months
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Assess the difference in MoCA Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
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baseline, 6 month, 12 month, 18 months
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Change of MMSE score
大体时间：baseline, 6 month, 12 month, 18 months
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Assess the difference in MMSE Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
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baseline, 6 month, 12 month, 18 months
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Change of CDR score
大体时间：baseline, 6 month, 12 month, 18 months
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Assess the difference in CDR Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
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baseline, 6 month, 12 month, 18 months
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Change of structural MRI
大体时间：baseline, 6 month, 12 month, 18 month
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3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)
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baseline, 6 month, 12 month, 18 month
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Change of functional MRI
大体时间：baseline, 6 month, 12 month, 18 month
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Blood oxygenation level dependent (BOLD) imaging
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baseline, 6 month, 12 month, 18 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年5月17日
首先提交符合 QC 标准的
2026年5月17日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月17日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.