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临床试验/NCT07060391
NCT07060391尚未招募3 期

A Prospective Multicenter RCT Study of Deep Jugular Lymphovenous Anastomosis in the Treatment of Alzheimer's Disease

Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 186 人开始时间: 2025年7月31日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
186
主要终点
ADAS-cog score

研究概览

简要总结

This research aims to observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease. This is a prospective multicenter RCT clinical research, involving a total of 3 research centers.Patients diagnosed with Alzheimer's disease accompanied by moderate to severe cognitive dysfunction in these three hospitals from January 2025 to January 2027 were included. This research is expected to recruit a total of 186 patients with moderate to severe Alzheimer's disease.93patients received conventional medical treatment, Deep cervical lymphatic-venous anastomosis was performed in 93 patients.Comprehensively evaluate the efficacy and safety of the patients within 48 weeks after treatment.

详细描述

Alzheimer's disease is a degenerative disorder of the central nervous system characterized by progressive cognitive dysfunction and behavioral impairment. At present, the treatment strategies for Alzheimer's disease include drug therapy, non-drug therapy and some emerging treatment methods. However, clinical evidence has confirmed that the effects of these treatment measures are limited. In recent years, Some neurosurgeons in China have begun to attempt to improve the disease progression of severe Alzheimer's disease through the innovative microscopic surgical method of deep jugular lymphovenous anastomosis. The therapeutic principle is Lymph node reconstruction is carried out using microsurgical techniques to improve the lymphatic circulation and return of the brain, accelerate the excretion of pathological proteins, the metabolic products of the brain, thereby delaying the degenerative changes of the brain and the progression of Alzheimer's disease. To verify the above assumption, this study will collaborate with a total of three institutions, namely Ruijin Hospital, Luwan Branch and Wuxi Branch. It is estimated that 186 patients with moderate to severe dementia of Alzheimer's disease will be included. They were randomly divided into the surgical treatment group (93 cases) and the traditional medical treatment group (93 cases). Cognitive function assessment, PETMR imaging examination, cerebrospinal fluid/blood testing and quality-adjusted life years were analyzed respectively at the 1st week, 4th week, 12th week, 24th week and 48th week after conservative treatment or surgery. To observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient was clinically diagnosed with Alzheimer's disease and had a moderate to severe cognitive function score.
  • Age: 30-80 years old.
  • Gender is not limited.
  • The patient or their family members authorize their willingness to participate in this clinical trial and sign the informed consent form.
  • no contraindications for surgery.

排除标准

  • A history of radiotherapy or surgery for the head and neck.
  • Patients or their families with poor compliance who cannot strictly follow the rules.
  • Patients who cannot tolerate surgery.
  • Patients with other diseases that affect cognitive function.
  • Patients who cannot tolerate donepezil drug treatment.

研究组 & 干预措施

Surgical treatment

Experimental

Deep cervical lymphatic-venous anastomosis

干预措施: Deep cervical lymphatic-venous anastomosis (Procedure)

Internal medicine conservative treatment

Placebo Comparator

Donepezil drug ,5-10mg,qd,po. All patients stopped taking cognitive-enhancing drugs and marketed therapeutic drugs such as ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, Memegan, etc. after enrollment.

干预措施: Donepezil drug treatment (Drug)

结局指标

主要结局

ADAS-cog score

时间窗: baseline,48 weeks

The improvement of 4 points by ADAS-cog is used as the judgment criterion for the clinical therapeutic effect, Compare the remission rates between the experimental group (surgery) and the control group (medication).

次要结局

  • Imaging data(From the first week to the 48th week)
  • Cerebrospinal fluid examination(From the first week to the 48th week)
  • Markers of Alzheimer's disease in the blood(From the first week to the 48th week)
  • Surgery-related adverse reactions(From the first week to the 48th week)
  • Quality-Adjusted Life Year(From the first week to the 48th week)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yijun Cheng

Principal investigator

Shanghai Jiao Tong University School of Medicine

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