Viewing Study NCT06448442



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06448442
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-07
First Post: 2024-06-03

Brief Title: A Pilot Study of Deep Cervical Lymphatic-venous Anastomosis in the Treatment of Alzheimers Disease
Sponsor: Second Affiliated Hospital School of Medicine Zhejiang University
Organization: Second Affiliated Hospital School of Medicine Zhejiang University

Study Overview

Official Title: A Pilot Study of Deep Cervical Lymphatic-venous Anastomosis in the Treatment of Alzheimers Disease
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Alzheimers disease AD is the most prevalent form of dementia affecting 3-4 of the population over a lifetime Its characterized by abnormal Amyloid-beta Aβ and tau protein expression and accumulation in the central nervous system leading to amyloid plaques and neurofibrillary tangles While current treatments can slow cognitive decline theres no cure

The discovery of the glymphatic-meningeal lymphatic system has shed new light on cerebrospinal fluid circulation showing it has a similar interstitial fluid system to peripheral lymphatic circulation This system helps clear waste and transport nutrients in the brain known as the glymphatic phenomenon The deep cervical lymph nodes part of this system are crucial for cerebrospinal fluid drainage and are linked to the clearance of AD-related proteins

Aging and inflammation can impair deep cervical lymph node function increasing cerebrospinal fluid drainage pressure and potentially contributing to AD progression Lymphatic anastomosis a surgical technique used for lymphedema and other conditions is being explored as a potential treatment to alleviate neurodegenerative disease by reducing cerebrospinal fluid pressure and clearing metabolic waste
Detailed Description: Alzheimers disease AD is the most common form of dementia with an estimated lifetime prevalence rate of 3-4 Its characteristics include abnormal expression of Amyloid-beta Aβ and tau proteins as well as their accumulation in the central nervous system The aggregated toxic proteins further form amyloid plaques and neurofibrillary tangles One of the biggest scientific and therapeutic challenges of AD is to elucidate this protein pathology and how it leads to accumulation in the central nervous system Although current drug treatment options can slow down the decline in cognitive abilities there is no treatment strategy to improve the disease

Recently the revelation of the glymphatic-meningeal lymphatic system has updated the latest theory of cerebrospinal fluid circulation There is an interstitial fluid circulation system in the brain tissue that is similar to peripheral lymphatic circulation Research has found that cerebrospinal fluid in the brain enters the perivascular space around the veins through the perivascular space around the arteries directed by the astrocyte Aquaporin protein-4 which promotes the clearance of waste and the transport of nutrients in the brain a phenomenon known as the glymphatic phenomenon At the same time research has found that there are a large number of lymphatic vessels on both sides of the dural venous sinuses which participate in the drainage of cerebrospinal fluid and eventually converge into the deep cervical lymph nodes In animal models of AD and Parkinsons disease PD the glymphatic-meningeal lymphatic drainage function is significantly related to the clearance of disease-related proteins such as amyloid beta Aβ tau and alpha-synuclein Ligation of the deep cervical lymph nodes significantly exacerbates the progression of the disease At the same time clinical studies have confirmed the decline of glymphatic-meningeal lymphatic function in patients with AD and PD through magnetic resonance imaging technology

The deep cervical lymph nodes play an important role as the final destination of cerebrospinal fluid drainage in the glymphatic-cranial lymphatic system With aging infection and chronic inflammation the function of the deep cervical lymph nodes gradually declines which will significantly increase the pressure of cerebrospinal fluid circulation and reflux in the brain The large amount of neurotoxic substances produced during the progression of AD will further lead to the dysfunction of the deep cervical lymph nodes ultimately leading to abnormal accumulation of toxic substances in the brain and the progression of the disease Lymphatic anastomosis is a surgical technique widely used for limb lymphedema post-traumatic chylous chest breast cancer and other post-tumor resection local edema and other diseases with high safety reliability and ease of operation and has been proven to have many advantages after half a century of testing Currently many hospitals at home and abroad have carried out related operations all of which have achieved good results Recently only in our province Zhejiang Provincial Peoples Hospital Taizhou Hospital Hangzhou Qiushi Hospital and others have carried out related operations and the famous Cleveland Clinic in the United States is also conducting related surgical treatment research

We speculate that anastomosing the corresponding lymphatic vessels in the neck with the veins Deep Cervical Lymph-Venous anastomosis might reduce the cerebrospinal fluid circulation pressure in the brain tissue accelerate the return of interstitial fluid in the brain tissue clear the accumulation of metabolic products and alleviate the progression of neurodegenerative diseases

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None