NCT06918145Enrolling By Invitation不适用
Clinical Study on the Safety, Efficacy, and Mechanisms of Lymphaticovenous Anastomosis (LVA) for the Treatment of Alzheimer's Disease (AD)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The assessment of score changes after Lymphaticovenous Anastomosis(LVA) for the treatment of Alzheimer's Disease(AD) using Mini-Mental State Examination(MMSE).
研究概览
简要总结
The goal of this clinical trial is to explore the safety and efficacy of Lymphaticovenous Anastomosis (LVA) for the Treatment of Alzheimer's Disease (AD). The main questions it aims to answer are:
- After LVA surgery treatment, do patients with AD show improvement in dementia, cognitive impairment, neurobehavioral symptoms?
- What are the complications associated with LVA treatment for AD, including perioperative complications and long-term complications?
- What is the mechanism of LVA treatment for AD patients, and what changes occur in AD-related biomarkers (Aβ42、 Aβ40、Aβ42/40、pTau217、pTau181) before and after surgery?
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Alzheimer's Disease based on biomarkers, imaging, and clinical symptoms;
- •Male or female aged 50-85 years (inclusive);
- •At least one caregiver who can live with the patient for an extended period;
- •No severe systemic diseases affecting the heart, liver, kidneys, etc.;
- •Patients who voluntarily participate in clinical recruitment, accept the LVA surgical treatment plan, and sign the informed consent form.
排除标准
- •Poor overall health, unable to tolerate surgery;
- •Preoperative anesthetic assessment indicates inability to tolerate general anesthesia;
- •Presence of other neurological or psychiatric disorders;
- •Severe bleeding tendency due to coagulopathy;
- •Inability to comply with treatment and follow-up;
- •Other conditions that preclude tolerance to surgery.
研究组 & 干预措施
Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD)
Experimental
干预措施: Lymphaticovenous Anastomosis (Procedure)
结局指标
主要结局
The assessment of score changes after Lymphaticovenous Anastomosis(LVA) for the treatment of Alzheimer's Disease(AD) using Mini-Mental State Examination(MMSE).
时间窗: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months,1 year, 3 years, 5 years.
The assessment of score changes by Mini-Mental State Examination(MMSE)
次要结局
- The safety of Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD)(From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months, 1 year, 3 years, 5 years.)
研究者
研究点 (1)
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