NCT07294885 · RECRUITING
Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease
This trial is testing a microsurgical procedure called deep cervical lymphaticovenous anastomosis — essentially connecting small lymphatic vessels in the neck to nearby veins — to see whether it genuinely improves symptoms in people with Alzheimer's disease, or whether early improvements seen in previous patients were due to the surgery itself versus other factors like anesthesia. It uses a sham surgery comparison group to find out the true cause. This is a Phase NA controlled trial — an early-stage test of whether the procedure actually does what it appears to do.
You may qualify if
- Age 50-80 years (inclusive), regardless of gender.
- Meeting the diagnostic criteria for Mild Cognitive Impairment or mild to moderate dementia due to Alzheimer's disease (according to the 2024 AA clinical diagnostic criteria for AD-related dementia).
- Disease duration of 6 months or longer, with no clinical improvement after 3 months or more of conservative treatment.
- MMSE score: 12-26.
- Biomarker confirmation of AD: positive Aβ-PET and tau-PET, or positive cerebrospinal fluid biomarkers.
- Having a reliable caregiver (providing companionship for ≥3 hours per day).
- Signed written informed consent from the patient or legally authorized representative.
You're excluded if
- Contraindications to MRI, ICG angiography, or PET.
- Contraindications to surgery or anesthesia, such as coagulation disorders (platelet count \<100×10⁹/L, INR >1.7).
- Comorbid major organ dysfunction, such as reduced left ventricular ejection fraction, severe hepatic or renal insufficiency (AST or ALT >3 times the upper limit of normal; eGFR \<30 mL/min/1.73m²).
- Intracranial structural lesions indicated by MRI, including brain tumors, cerebral infarction, intracranial hemorrhage, aneurysms, arteriovenous malformations, hydrocephalus, etc.
- MRI findings suggestive of significant cerebral small vessel disease features: more than one lacunar infarction in the deep white matter and periventricular regions and/or white matter hyperintensity (WMH) with a Fazekas grade >2, or the presence of ≥4 cerebral microbleeds.
- Other causes of dementia, such as hypothyroidism or vitamin B12 deficiency.
- Drug/alcohol addiction.
- Severe psychiatric illness or suicide risk.
- Comorbid medical conditions with a life expectancy of less than 1 year.
- Participation in another interventional trial within the past 3 months.
- Poor compliance or judged by the investigator as unsuitable for participation.
- Patients receiving therapy with Lecanemab or Donanemab.
- Other conditions that the researcher deems unsuitable for participation in this study.
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 2026-03-25