RecruitingPhase 3NCT06530732

Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)

Sponsor

Zhejiang Provincial People's Hospital

Enrollment

60 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Alzheimer s Disease

Summary

The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone) Participants will: Undergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline). Primary Outcome Measures: The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline

Eligibility

Plain Language Summary

Simplified for easier understanding

This is a pilot (early-stage) study testing a surgical procedure called deep cervical lymphatic-venous anastomosis (DIVA) for Alzheimer's disease. The procedure aims to improve the drainage of waste products from the brain (through the lymphatic system in the neck) as a potential treatment approach. **You may be eligible if...** - You are over 35 years old - You have been diagnosed with Alzheimer's disease based on both biological markers and clinical symptoms - Your cognitive score is 26 or below (indicating cognitive decline) - You or your family member has signed informed consent **You may NOT be eligible if...** - You cannot undergo a lumbar puncture (spinal tap) - Your cognitive decline is caused by another condition (e.g., infection, thyroid disease, autoimmune encephalitis) - You have significant organ dysfunction (heart, liver, kidney problems) - You have other serious neurological or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDeep Cervical lymphatlc-Venous Anastomosis Surgery

Cervical deep lymphatic-venous anastomosis (dcLVA) can promote the flow of cerebrospinal fluid within the glymphatic system. The procedure involves connecting deep cervical lymphatic vessels to veins, reducing pressure on lymph nodes and allowing lymphatic fluid from high-pressure vessels to flow into the lower-pressure venous system. This surgical intervention enhances the clearance of waste in the glymphatic system, particularly amyloid-beta (Aβ) and tau proteins. By facilitating the removal of these AD-associated proteins from the brain, dcLVA can reduce local tissue fibrosis and cervical nerve compression, potentially reversing degenerative changes, slowing disease progression, and improving the quality of life for AD patients.

DRUGLecanemab

The newly approved anti-beta-amyloid (Aβ) monoclonal antibody Lecanemab can delay AD progression but is only suitable for patients in the early stages. For those with moderate to severe AD, Lecanemab is not effective.