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Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)

RecruitingPhase 3Ages any - anyAllZhejiang Provincial People's Hospital
NCT06530732 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Deep Cervical lymphatlc-Venous Anastomosis Surgery
  • Lecanemab
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Where

1 site
Zhejiang Provincial People's Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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