NCT07680660 · NOT YET RECRUITING
Efficacy of Lymphatic-Venous Anastomosis Plus Donepezil Versus Donepezil Alone for Alzheimer's Disease
This trial is testing whether a surgical procedure — connecting lymphatic vessels in the neck directly to veins, to improve fluid drainage from the brain — combined with the standard Alzheimer's drug donepezil works better than donepezil alone. It measures cognitive decline over 18 months using standardized tests, brain imaging, and spinal fluid biomarkers. This is a Phase N/A multicenter randomized controlled trial, meaning it is designed to test efficacy and safety in a defined patient group.
You may qualify if
- The patient or guardian signs the informed consent form;
- Age 50-80 years (≥50 years, ≤80 years), male or female;
- The first diagnosis is Alzheimer's disease with dementia;
- MMSE score ≤24;
- Positive β-amyloid protein PET imaging findings;
- HAMD score ≤17;
- Hachinski score ≤7;
- No AD-related drug treatment has been received within the past 1 month;
- ASA grade 1-3 (≥ grade 1, ≤ grade 3).
- CDR-SB score of 9.5-15.5
You're excluded if
- Presence of contraindications to MRI, ICG angiography, or PET scan;
- Presence of contraindications to lumbar puncture;
- Severe heart disease or unstable hemodynamic status;
- Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months;
- Hepatic insufficiency, AST or ALT >3 times the upper limit of normal;
- Renal insufficiency, GFR \<60 mL/min or need for blood purification treatment;
- MRI indicates active or acute intracranial lesions, including intracranial infection, space-occupying lesions, major hemorrhage, and ≥4 lobar microbleeds, etc.;
- History of cerebral hemorrhage or cerebral infarction with severe residual neurological dysfunction;
- Blood diseases, bleeding/coagulation disorders, coagulation dysfunction;
- Abnormal thyroid function;
- Moderate or severe stenosis of intracranial or cervical vessels with severe residual neurological dysfunction;
- Severe hypertension not effectively controlled, systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
- The disease requires systemic use of steroids;
- Drug addiction (including alcohol, narcotics, and alcohol dependence);
- Severe infectious diseases, including HIV positivity, severe infection, etc.;
- Severe psychiatric disease or potential suicide risk;
- Within 3 years after radical surgery for malignant tumor;
- Participation in other interventional clinical trials within the past three months;
- In the physician's judgment, poor compliance, inability to complete, or unwillingness to cooperate with regular postoperative follow-up;
- Other circumstances that the physician considers unsuitable for this clinical trial.
- Anti-Aβ monoclonal antibody treatment has been received within half a year
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 2026-07-02