Surgical Protocols for Deep Cervical Lymphovenous Anastomosis in a Rat Model: Lymph Node and Lymphatic Vessel Anastomoses.
Nannan Zhao, Yang Wang, Songyu Yang...
https://pubmed.ncbi.nlm.nih.gov/41325201Actively Recruiting
Phase 3
All Genders
ID06530732
Deep Cervical Lymphatic-Venous Anastomosis Surgery Combined with Standard Medication for Alzheimer’s Disease Treatment: A Randomized Pilot Study (DIVA Study)
Led by Zhejiang Provincial People's Hospital · Updated on 2025-01-16
60
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of deep cervical lymphatic-venous anastomosis (dcLVA) surgery combined with standard medication compared to standard medication alone for treating Alzheimer's Disease (AD). This Phase 3 study includes patients diagnosed with AD based on biological markers and clinical symptoms. The study aims to understand if this surgical procedure can improve cognitive function and glymphatic clearance, which may help reduce disease progression. Participants will be randomly assigned to either receive the dcLVA surgery plus standard medication or only the standard medication. The dcLVA surgery connects deep cervical lymphatic vessels to veins to help clear waste proteins like amyloid-beta and tau from the brain. After randomization, participants will undergo cognitive tests, brain MRI scans, a lumbar puncture, and an injection of a contrast agent (gadodiamide). MRI scans will be taken at 4, 24, and 48 hours after the injection to assess glymphatic system function. Throughout the study, cognitive function and glymphatic clearance will be monitored at baseline, 7 days after surgery, and at 6 and 12 months. The main outcome measured is the change in the Clinical Dementia Rating Scale (CDR) score over 12 months. Safety and effectiveness of the two treatment methods will be carefully evaluated. Participants will have multiple assessments including imaging, cognitive testing, and lumbar puncture to track progress during the year-long follow-up.
CONDITIONS
Official Title
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed as an Alzheimer's Disease patient based on biological markers and clinical symptoms
- Age over 35 years
- Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MOCA) score of 26 or less
- Patient or family member has signed an informed consent form
You will not qualify if you...
- Unable to cooperate with lumbar puncture
- Cognitive impairment caused by neurological infections such as HIV, neurosyphilis, or autoimmune encephalitis, or by systemic diseases like diabetes or thyroid dysfunction
- Significant dysfunction of heart, lung, liver, or kidney
- Coagulation disorders or any contraindications to surgery
- Unable to fully cooperate with follow-up visits
AI-Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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