Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease

Sponsor
General Hospital of Shenyang Military Region
Study ID
NCT07294885
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • deep cervical lymphaticovenous anastomosis — PROCEDURE
    patients will receive deep cervical lymphaticovenous anastomosis

Study Details

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.

Key Dates

First listed
Dec 19, 2025
Start date
Mar 20, 2026
Status verified
Mar 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LVA group
    patients will receive lymphaticovenous anastomosis
  • Sham Comparator: Sham group
    patients will undergo the LVA surgical procedure without performing the lymphaticovenous anastomosis.

Primary Outcome Measure

Changes in Montreal Cognitive Assessment (MoCA) score [ Time Frame: 4±1 days ]

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