A Phase 3 interventional study of Deep Cervical lymphatlc-Venous Anastomosis Surgery and Lecanemab in Alzheimer's Disease, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Zhejiang Provincial People's Hospital · Phase 3, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
receiving dcLVA surgery plus standard medication
Procedure: Deep Cervical lymphatlc-Venous Anastomosis Surgery · Drug: Lecanemab
receiving standard medication alone
Drug: Lecanemab
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.
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.
The rate of change in the total score of the Clinical Dementia Rating Scale
The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline , using the Chinese version of the CDR scale, with a score range of 0-3 points for each item.The total score ranges from a minimum of 0 points to a maximum of 18 points, where a higher score indicates a worse outcome.
Time frame: Time Frame: baseline,7 days post-surgery,3-month,6-month and 12-month
Plan to share: No
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Zhejiang Provincial People's Hospital