NCT07669272 · NOT YET RECRUITING
Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease
This trial is testing a surgical procedure called deep cervical lymphovenous anastomosis, or DCLVA, for people with severe Alzheimer's disease. The surgery connects lymphatic vessels in the neck to veins, with the goal of improving how the brain drains waste proteins like amyloid and tau. It is a Phase NA study — meaning it sits outside the standard drug-approval phases, focused here on evaluating surgical efficacy and safety in 59 patients over 12 months.
You may qualify if
- Meet the 2011 NIA-AA clinical diagnostic criteria for probable Alzheimer's disease dementia and the 2018 NIA-AA research framework biomarker criteria for AD.
- Aged 50 to 80 years (inclusive) at the time of signing informed consent.
- Severe cognitive dysfunction: Mini-Mental State Examination (MMSE) score \< 10 points.
- Progressive cognitive deterioration for more than 6 months reported by patient or caregiver.
- No clinical improvement after more than 6 months of standardized drug treatment.
- Have a designated study companion who signs informed consent, contacts the patient at least 10 hours per week and accompanies study visits.
- Able to complete scale assessments and examinations independently or with companion assistance.
- Voluntarily comply with study procedures, examinations and surgical treatment.
- Patient or legal representative can sign written informed consent and abide by trial requirements.
- Patients and families are informed of study purpose, expected efficacy and potential risks, and voluntarily provide biological samples and participate in the study.
You're excluded if
- Severe central nervous system diseases (other than AD) that affect cognitive function or study compliance.
- Severe/unstable systemic diseases (cardiovascular, hepatic, renal, respiratory, endocrine, hematological, psychiatric diseases); life expectancy less than 24 months.
- Surgical contraindications: severe coagulation disorders, severe -cardiopulmonary diseases (myocardial infarction/respiratory failure within recent 30 days); severe liver damage (ALT/AST > 3 times upper limit of normal); severe renal insufficiency (eGFR \< 30ml/min).
- Severe primary mental disorders (other than AD) that interfere with efficacy evaluation and cognitive assessment.
- History of intracranial hemorrhage or craniocerebral trauma within recent 1 year.
- Alcohol or drug abuse/dependence within recent 1 year.
- Allergy to indocyanine green, gadolinium contrast agent, 18F-florbetapir or 18F-flortaucipir.
- Contraindications for PET examination.
- Other conditions judged by investigators unsuitable for enrollment.
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 2026-06-25