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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
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Start Date
July 1, 2024
Primary Completion Date
June 30, 2026
Completion Date
September 30, 2026
Last Updated
January 16, 2025
60
ESTIMATED participants
Deep Cervical lymphatlc-Venous Anastomosis Surgery
PROCEDURE
Lecanemab
DRUG
Lead Sponsor
Zhejiang Provincial People's Hospital
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07033494