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

NCT ID: NCT06448975

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-07-01

Brief Summary

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.

Detailed 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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Deep cervical Lymphovenous Bypass

Intervention Type: PROCEDURE

Deep cervical lymph-vein bypass surgery, connecting deep cervical lymph input vein vessel

Interventions

Deep cervical Lymphovenous Bypass

Deep cervical lymph-vein bypass surgery, connecting deep cervical lymph input vein vessel

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lu Hua

Role: STUDY_DIRECTOR

Affiliated Hosptial Of Jiangnan University

Locations

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Hua

Role: CONTACT

luhua1969@hotmail.com

08615301516197

Facility Contacts

Lu hua

Role: primary

luhua1969@hotmail.com

08615301516197

Other Identifiers

19691027

Identifier Type: -

Identifier Source: org_study_id