Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT06852352

An Exploratory Study to Confirm Efficacy of Modified Deep Cervical Lymphovenous Anastomosis (LVA) in Alzheimer's Disease/ Parkinson's Disease

Led by Zhejiang Provincial People's Hospital · Updated on 2025-03-11

160

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

Z

Zhejiang Provincial People's Hospital

Lead Sponsor

Z

Zybio Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

An Exploratory Study to Confirm Efficacy of Modified Deep Cervical Lymphovenous Anastomosis (LVA) in Alzheimer's Disease/ Parkinson's Disease

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For Alzheimer's disease: Age 50 to 75 years
  • For Parkinson's disease: Age 50 to 80 years
  • Male or female participants
  • Signed informed consent by patient or legal representative
  • Diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease
  • Positive Amyloid PET imaging (Centiloids 37) for Alzheimer's disease
  • Hamilton Depression Rating Scale (HAMD) score 17 for Alzheimer's disease
  • Hachinski score  for Alzheimer's disease
  • American Society of Anesthesiologists (ASA) grade I-III
  • Diagnosis of Parkinson's disease or probable Parkinson's disease by established clinical criteria
  • Parkinson's disease patients at stage I-IV by Hoehn and Yahr Scale
  • Parkinson's disease history of more than 2-5 years to confirm stable symptoms
Not Eligible

You will not qualify if you...

  • Contraindications for MRI, ICG angiography, or PET scanning
  • Contraindications for lumbar puncture
  • Severe impairment of vital organs including heart, lungs, kidneys, liver
  • MRI signs of active brain infections, tumors, major bleeding, or 4 or more lobar microhemorrhages
  • Blood disorders increasing risk of brain bleeding
  • Poorly controlled thyroid disease
  • Cerebrovascular or systemic blood vessel disease
  • Severe heart disease or unstable circulation
  • Uncontrolled severe high blood pressure
  • Substance use disorders including drugs, anesthetics, or alcohol dependence
  • Active severe infections including HIV or critical infections
  • Severe psychiatric illness or high suicide risk
  • Chronic use of hypnotic drugs more than twice weekly for over a month
  • Untreated or uncured cancers
  • Participation in other clinical trials within past 3 months
  • Poor compliance or unwillingness to complete post-surgery follow-up
  • Other contraindications as determined by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China, 310014

Actively Recruiting

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Research Team

Y

Youmao Zheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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