Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease

NCT07294885 | Recruiting DMC

• 1 other identifier: Y (2025) 250
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

• Changes in Montreal Cognitive Assessment (MoCA) score

  MoCA ranges from 0 to 30, with higher score meaning better outcome

  4±1 days

• Changes in Mini-mental State Examination (MMSE) score

  MMSE ranges from 0 to 30, with higher score meaning better outcome

  4±1 days

• Changes in Barthel index (BI)

  BI ranges from 0 to 100, with higher score meaning better outcome

  4±1 days

• 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

  4±1 days

Secondary Outcomes (5)

• Changes in Montreal Cognitive Assessment (MoCA) score

  90±7 days; 180±15 days; 270±20 days

• Changes in Mini-mental State Examination (MMSE) score

  90±7 days; 180±15 days; 270±20 days

• Changes in Barthel index (BI)

  90±7 days; 180±15 days; 270±20 days

• Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus)

  90±7 days; 180±15 days; 270±20 days

• Severe adverse events

  Perioperative period

Study Arms (2)

LVA group

EXPERIMENTAL

patients will receive lymphaticovenous anastomosis

Procedure: deep cervical lymphaticovenous anastomosis

Sham group

SHAM COMPARATOR

patients will undergo the LVA surgical procedure without performing the lymphaticovenous anastomosis.

Procedure: deep cervical lymphaticovenous anastomosis

Interventions

deep cervical lymphaticovenous anastomosis PROCEDURE

patients will receive deep cervical lymphaticovenous anastomosis

LVA group; Sham group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)