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

Not Applicable

Not yet recruiting

• Conditions: Alzheimer's Disease
• Interventions: Procedure: Deep cervical lymphatic-venous anastomosis; Drug: Donepezil drug treatment

• Registration Number: NCT07060391
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-22
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-07-31
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment	Deep cervical lymphatic-venous anastomosis	Deep cervical lymphatic-venous anastomosis
Internal medicine conservative treatment	Donepezil drug treatment	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.

Primary Outcome Measures

Name	Time	Method
ADAS-cog score	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).

Secondary Outcome Measures

Name	Time	Method
Imaging data	From the first week to the 48th week	PET-MRI labeled with specific tracers shows the changes in amyloid protein or tau deposition, Quantify and statistically analyze the changes between the two groups.
Cerebrospinal fluid examination	From the first week to the 48th week	Test the Alzheimer's disease markers such as amyloid protein or tau deposition in the cerebrospinal fluid between the two groups, count the changes between the two groups.
Markers of Alzheimer's disease in the blood	From the first week to the 48th week	Test the changes of Alzheimer's disease markers such as amyloid protein in the blood between the two groups,count the changes between the two groups.
Surgery-related adverse reactions	From the first week to the 48th week	The occurrence of complications:such as postoperative bleeding,Peripheral nerve injury,Lymphatic vessel leakage,Cardiovascular and cerebrovascular events, etc.
Quality-Adjusted Life Year	From the first week to the 48th week	It is a health outcome evaluation index that comprehensively considers survival time and quality of life. The survival time and quality of life of the intervention group and the medication group were compared. The calculation method is Survival Time (years) × Health Utility Value, The health utility value is a quality weight reflecting a specific health status(1 indicates complete health, 0 indicates death, and a negative value indicates a state worse than death). The utility values of patients under different health conditions were evaluated through the Quality of life assessment scale, an assessment should be conducted every six months after treatment. Multiply the duration of each health state by the corresponding utility value. Then accumulate to obtain the Quality-Adjusted Life Year score.