๐ฌIn plain words
What the trial is, and whether it could suit you
Lymphaticovenous anastomosis (LVA) is a microsurgical technique that involves anastomosing fine lymphatic vessels with adjacent veins to reestablish lymphatic drainage pathways. It is used in the treatment of lymphedema-related conditions and is characterized by minimal invasiveness and rapid recovery. Based on findings from animal studies, some physicians in China have attempted deep cervical lymphatic-venous anastomosis to improve intracranial lymphatic drainage in patients with Alzheimer's disease (AD). Most studies, including those from our center, have observed early postoperative improvements in various domains such as mood, memory, executive function, and communication abilities in the majority of patients. However, these symptomatic improvements are not sustained. The reasons for the early improvements remain unclear. Are they due to enhanced lymphatic drainage resulting from the
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 Aฮฒ-PET and tau-PET, or positive cerebrospinal fluid biomarkers.
* Having a reliable caregiver (providing companionship for โฅ3 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 \<100ร10โน/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/1.73mยฒ).
* 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 โฅ4 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.