Surgery to reduce protein buildup

Trial ID
NCT06852352
Official Title
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
Goal
Surgery to reduce protein buildup
Phase
NA
Status
RECRUITING
Sponsor
Zhejiang Provincial People's Hospital
Study Type
INTERVENTIONAL
Enrollment
160 participants
Conditions
Alzheimer Disease, Parkinson Disease
Interventions
Modified deep cervical Lymphatic-Venous Anastomosis

Plain-Language Summary

Aimed at improving brain waste clearance in Alzheimer's and Parkinson's, the trial tests whether surgically connecting deep cervical lymphatic vessels into nearby veins can reduce buildup of proteins like amyloid and alpha-synuclein and slow symptom progression over 24 months. The procedure, a modified deep cervical lymphatic-venous anastomosis, creates a new drainage route so cerebrospinal and interstitial fluid can leave the brain more efficiently, and it would be used alongside, not instead of, standard medications. They are looking for adults in two groups: people with Alzheimer's aged 50 to 75 who have positive amyloid PET scans, and people with Parkinson's aged 50 to 80 with Hoehn and Yahr stage I to IV and at least a couple years of stable symptoms. Candidates must be able to consent and be medically fit for MRI, PET, lumbar puncture, and surgery, and people with serious medical, bleeding, or uncontrolled psychiatric conditions are excluded.

Locations

  • Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Frequently Asked Questions

What is this trial testing?
This trial is studying Modified deep cervical Lymphatic-Venous Anastomosis. Aimed at improving brain waste clearance in Alzheimer's and Parkinson's, the trial tests whether surgically connecting deep cervical lymphatic vessels into nearby veins can reduce buildup of proteins like amyloid and alpha-synuclein and slow symptom progression over 24 months. The procedure, a modified deep cervical lymphatic-venous anastomosis, creates a new drainage route so cerebrospinal and interstitial fluid can leave the brain more efficiently, and it would be used alongside, not instead of, standard medications. They are looking for adults in two groups: people with Alzheimer's aged 50 to 75 who have positive amyloid PET scans, and people with Parkinson's aged 50 to 80 with Hoehn and Yahr stage I to IV and at least a couple years of stable symptoms. Candidates must be able to consent and be medically fit for MRI, PET, lumbar puncture, and surgery, and people with serious medical, bleeding, or uncontrolled psychiatric conditions are excluded.
Who can participate?
Participants must be between 50 Years and 80 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 2 years and 4 months.

View on ClinicalTrials.gov