About this trial
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 surgery itself, or are they attributable to other factors such as anesthetic effects, vascular release, or modulation of sympathetic nerves? Therefore, it is necessary to conduct a randomized controlled trial with a sham surgery group to clarify the causes of early clinical symptom improvements. Based on this, this project aims to carry out a prospective, single-center, randomized double-blind controlled study to evaluate whether the early symptomatic improvements following deep cervical LVA in AD patients are attributable to the surgical intervention itself or to other aspects of the procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
deep cervical lymphaticovenous anastomosis
Procedure/Surgerypatients will receive deep cervical lymphaticovenous anastomosis
Treatment groups
Trial outcomes
Primary outcomes
Changes in Montreal Cognitive Assessment (MoCA) score
MoCA ranges from 0 to 30, with higher score meaning better outcome
Changes in Mini-mental State Examination (MMSE) score
MMSE ranges from 0 to 30, with higher score meaning better outcome
Changes in Barthel index (BI)
BI ranges from 0 to 100, with higher score meaning better outcome
Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus)
CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome
Secondary outcomes
Changes in Montreal Cognitive Assessment (MoCA) score
MoCA ranges from 0 to 30, with higher score meaning better outcome
Changes in Mini-mental State Examination (MMSE) score
MMSE ranges from 0 to 30, with higher score meaning better outcome
Changes in Barthel index (BI)
BI ranges from 0 to 100, with higher score meaning better outcome
Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus)
CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome
Sponsors and contacts
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