Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
Recruiting · NCT06530732 · Interventional (participants receive a specific treatment) · Lead sponsor: Zhejiang Provincial People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Inclusion criteria
- Diagnosed as an AD patient according to biological markers and clinical symptoms;
- Over 35 years old and with an MMSE or MOCA score ≤ 26;
- The patient or family member has signed an informed consent form.
Exclusion criteria
- Inability to cooperate with lumbar puncture;
- Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);
- Significant organ dysfunction (heart, lung, liver, kidney);
- Coagulation disorders or contraindications to surgery;
- Inability to fully cooperate with follow-up visits.
Where it is running
1 location listed.
- Zhejiang Provincial People's Hospital - Hangzhou, Zhejiang, China