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

Last updated: January 14, 2025
Sponsor: Zhejiang Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Alzheimer's Disease

Memory Loss

Dementia

Treatment

Deep Cervical lymphatlc-Venous Anastomosis Surgery

Lecanemab

Clinical Study ID

NCT06530732
KY2024106
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed as an AD patient according to biological markers and clinical symptoms;

  • Over 35 years old and with an MMSE or MOCA score ≤ 26;

  • The patient or family member has signed an informed consent form.

Exclusion

Exclusion Criteria:

  • Inability to cooperate with lumbar puncture;

  • Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis,autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);

  • Significant organ dysfunction (heart, lung, liver, kidney);

  • Coagulation disorders or contraindications to surgery;

  • Inability to fully cooperate with follow-up visits.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Deep Cervical lymphatlc-Venous Anastomosis Surgery
Phase: 3
Study Start date:
July 01, 2024
Estimated Completion Date:
September 30, 2026

Study Description

This study aims to enroll patients diagnosed with AD. 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). Following randomization, patients will undergo cognitive and brain MRI assessments, a lumbar puncture, and an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline). MRI imaging scans will be conducted at 4 hours, 24 hours, and 48 hours post-injection to measure the dural signal unit ratio, which will be used to assess glymphatic clearance function. The study will track changes in cognitive function and glymphatic clearance function at baseline and during follow-up periods (7 days post-surgery, 6 months, and 12 months) and will evaluate the safety of the two treatment approaches.

Connect with a study center

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Active - Recruiting

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