Actively Recruiting
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A 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
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
CONDITIONS
Official Title
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
Who Can Participate
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
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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