Clinical trial NCT06448975: An Exploratory Study of Deep Cervical Lymphovenous Bypass (LVB) in Alzheimer's Disease
Official title: An Exploratory Study of Deep Cervical Lymphovenous Bypass (LVB) in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Deep Cervical Lymphovenous Bypass
Alzheimer Disease
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PET scan
timeFrame: Baseline ,6 months ,12 months
measure: The Alzheimer's Disease Comprehensive Rating Scale (iADRS)
timeFrame: Baseline ,1 week ,1 month ,3 months ,6 months ,12 months
Secondary outcomes:
measure: Plasma Aβ1-42 and plasma p-tau181
timeFrame: Baseline ,1 month ,6 months ,12 months
measure: Mini-Mental State Examination(MMSE)
timeFrame: Baseline ,1 week ,1 month ,3 months ,6 months ,12 months
measure: Montreal Cognitive Assessment(MoCA)
timeFrame: Baseline ,1 week ,1 month ,3 months ,6 months ,12 months
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
affiliation: Affiliated Hosptial Of Jiangnan University
name: Lu Hua
role: STUDY_DIRECTOR
References: