A Prospective, Single-center, Single-arm, Exploratory, 24-Month Study to Confirm Efficacy of Modified Deep Cervical Lymphovenous Anastomosis (LVA) in Subjects with Alzheimer's Disease/ Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Alzheimer's disease (AD) and Parkinson's disease (PD) are characterized by pathological protein accumulation in the brain-Aβ/tau in AD and α-synuclein in PD. Recent studies have indicated that age-related lymphatic vessel atrophy compromises the metabolic clearance capacity of meningeal lymphatic vessels, potentially disrupting the equilibrium between production and clearance of Aβ/α-synuclein, ultimately leading to pathological accumulation of these proteins within the brain. Deep cervical lymphovenous anastomosis (LVA), a surgical technique proven effective in restoring lymphatic drainage in lymphedema, may enhance clearance of neurotoxic proteins by improving cervical lymphatic outflow. This project aims to evaluate the efficacy of modified deep cervical LVA in treating AD and PD, establishing a novel therapeutic strategy to modify disease progression and improve quality of life in neurodegenerative disorders, additionally offering the pathogenic mechanisms underlying neurodegenerative disorders.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
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⁃ Alzheimer's disease:

• Male or female, the age ranged from 50 to 75 years old

• Informed consent signed and dated by patient or legal representative

• Patients diagnosed principally with mild cognitive impairment or dementia caused by Alzheimer's disease

• Positive result of Amyloid PET imaging (Centiloids ≥37)

• HAMD score ≤17

• Hachinski score ≤4 Patients who meet ASA (American Society of Anesthesiologists) grade I-III criteria

⁃ Parkinson's disease:

• Male or female, the age ranged from 50 to 80 years old

• Informed consent signed and dated by patient or legal representative

• Patients diagnosed with Parkinson's disease or probable Parkinson's disease according to the Clinical Diagnostic Criteria for Parkinson's Disease in China (2016) or MDS

• Stage I-IV patients according to Hoehn and Yahr Scale

• Patients documented history of Parkinson's disease for more than 2-5 years to ensure clinical stability of symptoms and exclude the possibility of early misdiagnosis of other conditions

Locations
Other Locations
China
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Youmao Zheng
Zhengym6228@gmail.com
+86-571-85335800
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 160
Treatments
Experimental: The clinically diagnosed patients with MCI or mild-moderate dementia caused by AD/PD
Sponsors
Leads: Zhejiang Provincial People's Hospital
Collaborators: Zybio Inc.

This content was sourced from clinicaltrials.gov