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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZhejiang Provincial People's Hospital

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Deep Cervical lymphatlc-Venous Anastomosis Surgery
  • Lecanemab

Treatment groups

60 Participants
are divided into 2 treatment groups