Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated January 16, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-28; most recent amendment 2025-01-14.
Trial Details
NCT Number NCT06530732
Lead Sponsor Zhejiang Provincial People's Hospital
Conditions Alzheimer's Disease
Enrollment 60 participants
Start Date 2024-07-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-01-16