An Exploratory Study of Deep Cervical Lymphovenous Bypass (LVB) in Alzheimer's Disease

Affiliated Hospital of Jiangnan University

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Procedure: Deep cervical Lymphovenous Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT06448975

19691027

Details and patient eligibility

About

The main pathological mechanism of Alzheimer's Disease (AD) is the abnormal deposition of amyloid-beta (Aβ) and tau proteins in the brain. Recent studies indicate that these two proteins are primarily cleared through the glymphatic system-meningeal lymphatic vessels-deep cervical lymphatic vessels pathway. Lymphatic circulation disorders in elderly patients can directly lead to the abnormal deposition of these proteins. Deep cervical lymphovenous bypass can improve lymphatic circulation and effectively treat lymphedema. This project aims to verify the effectiveness of 'deep cervical lymphovenous bypass' in treating AD, offering a new surgical treatment method to improve cognitive impairment and the quality of life for AD patients.

Full description

Alzheimer's Disease (AD) is a progressive neurodegenerative disorder that insidiously begins. Clinically characterized by memory impairment, aphasia, apraxia, agnosia, and other symptoms, it poses a severe threat to the quality of life of the elderly and brings a heavy burden to society and families. To date, there are no effective methods to prevent, halt, or cure AD. Therefore, there is an urgent need to explore new treatment approaches.

The definition of the glymphatic system and the discovery of meningeal lymphatic vessels (MLV) have overturned the traditional view of the immune privilege of the central nervous system, offering new clues and hope for the study and treatment of many brain diseases, including AD. The main pathological mechanism of Alzheimer's Disease (AD) is the abnormal deposition of amyloid-beta (Aβ) and tau proteins in the brain. Recent research indicates that these two proteins are primarily cleared through the glymphatic system-meningeal lymphatic vessels-deep cervical lymphatic vessels pathway, and lymphatic circulation disorders in elderly patients can directly lead to the abnormal deposition of these proteins. Deep cervical lymphovenous bypass can improve lymphatic circulation and effectively treat lymphedema. This project aims to verify the effectiveness of 'deep cervical lymphovenous bypass' in treating AD, providing a new surgical method to improve cognitive impairment and the quality of life for AD patients.

Enrollment: 30 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age ranged from 60 to 80 years, and the time from initial diagnosis to enrollment was more than 12 months
2. The estimated survival time is more than 12 months;
3. The clinically diagnosed patients with mild to severe Alzheimer's Disease;
4. The imaging examination has the correlation diagnosis evidence;
5. Volunteer to participate in the project and sign an informed consent form with the guardian.

Exclusion criteria

1. Complicated with other severe systemic underlying diseases;
2. Unable to tolerate general anesthesia;
3. The pregnant women;
4. Recent severe infection or infectious diseases within 4 weeks;
5. Unable to complete the evaluator or refused to complete the one-year clinical follow-up.
6. Refusal to participate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

The clinically diagnosed patients with mild to severe Alzheimer's Disease

Experimental group

Description:

1. The age ranged from 60 to 80 years, and the time from initial diagnosis to enrollment was more than 12 months 2. The estimated survival time is more than 12 months; 3. The clinically diagnosed patients with mild to severe Alzheimer's Disease; 4. The imaging examination has the correlation diagnosis evidence; 5. Volunteer to participate in the project and sign an informed consent form with the guardian.

Treatment:

Procedure: Deep cervical Lymphovenous Bypass