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

NCT06448975 | Recruiting

• 1 other identifier: 19691027
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Deep Cervical Lymphovenous Bypass; Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• PET scan

  Detecting changes in the brain's amyloid and tau protein burden before and after surgery.Aβ/tau positron emission tomography (PET) facilitates spatial visualization and quantitative analysis of abnormal protein accumulations in the brains of Alzheimer's disease (AD) patients, offering objective imaging data crucial for early diagnosis, disease assessment, post-operative efficacy monitoring, and prognostic evaluations. Interpretations and quantitative assessments of Aβ-PET images are primarily focused on four cerebral regions: the lateral temporal cortex, frontal lobe, posterior cingulate gyrus/precuneus, and parietal lobe, aiding in the diagnosis of AD. The deposition of tau protein is positively correlated with disease severity; it initially accumulates predominantly in the medial temporal lobe and extends to neocortical regions during the middle and late stages. Tau PET is instrumental for monitoring disease progression and evaluating treatment outcomes.

  Baseline ,6 months ,12 months

• The Alzheimer's Disease Comprehensive Rating Scale (iADRS)

  The change in iADRS scores before and after surgery. The iADRS is a simple linear combination of two recognized, treatment-sensitive, and widely accepted measures of Alzheimer's Disease (AD), namely the AD Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL), used for the measurement of core assessment domains in AD.The total score of ADAS-Cog ranges from 0 to 70, with higher scores indicating greater cognitive impairment. The total score of ADCS-iADL ranges from 0 to 78, assessing the ability to perform complex activities of daily living, with higher scores indicating greater functional impairment.

  Baseline ,1 week ,1 month ,3 months ,6 months ,12 months

Secondary Outcomes (3)

• Plasma Aβ1-42 and plasma p-tau181

  Baseline ,1 month ,6 months ,12 months

• Mini-Mental State Examination(MMSE)

  Baseline ,1 week ,1 month ,3 months ,6 months ,12 months

• Montreal Cognitive Assessment(MoCA)

  Baseline ,1 week ,1 month ,3 months ,6 months ,12 months

Study Arms (1)

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

EXPERIMENTAL

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.

Procedure: Deep cervical Lymphovenous Bypass

Interventions

Deep cervical Lymphovenous Bypass PROCEDURE

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

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

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lu Hua

  Affiliated Hosptial Of Jiangnan University

  STUDY DIRECTOR

Central Study Contacts

Lu Hua

CONTACT

08615301516197; luhua1969@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CN (1)