Deep neck lymphatic-to-vein surgery for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Investigators perform deep cervical lymphatic-venous anastomosis, a microsurgical technique that connects lymphatic vessels to nearby veins to attempt to restore intracranial lymphatic drainage. The procedure is relatively minimally invasive and has been used for peripheral lymphedema treatment. Animal studies and small clinical series in China have reported early postoperative improvements in mood, memory, executive function, and communication, but those benefits were often transient and not sustained. This trial enrolls adults 50–80 with biomarker-confirmed AD (positive amyloid and tau PET or CSF) and MMSE 12–26, and excludes people with contraindications to imaging, surgery, anesthesia, or major organ dysfunction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Department of Neurology, General Hospital of Northern Theater Command
  Shenyang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.