NCT06530732 · Phase 3 · RECRUITING
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
This trial tests whether a surgical procedure called deep cervical lymphatic-venous anastomosis (dcLVA) — which aims to improve fluid drainage from the brain — can slow Alzheimer's progression when added to standard medication, including the drug lecanemab. Researchers will measure changes in a standard dementia rating scale over 12 months. It is a Phase 3 pilot study, meaning it is testing effectiveness at meaningful scale, though labeled a pilot suggesting relatively small numbers.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-16