Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06918145

Clinical Study on Lymphaticovenous Anastomosis（LVA） for the Treatment of Alzheimer's Disease（AD）

The goal of this clinical trial is to explore the safety and efficacy of Lymphaticovenous Anastomosis (LVA) for the Treatment of Alzheimer's Disease (AD). The main questions it aims to answer are:

1. After LVA surgery treatment, do patients with AD show improvement in dementia, cognitive impairment, neurobehavioral symptoms? 2. What are the complications associated with LVA treatment for AD, including perioperative complications and long-term complications? 3. What is the mechanism of LVA treatment for AD patients, and what changes occur in AD-related biomarkers (Aβ42、 Aβ40、Aβ42/40、pTau217、pTau181) before and after surgery?

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Alzheimer's Disease (AD)

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with Alzheimer's Disease based on biomarkers, imaging, and clinical symptoms;
  • Male or female aged 50-85 years (inclusive);
  • At least one caregiver who can live with the patient for an extended period;
  • No severe systemic diseases affecting the heart, liver, kidneys, etc.;
  • Patients who voluntarily participate in clinical recruitment, accept the LVA surgical treatment plan, and sign the informed consent form.

Exclusion criteria

  • Poor overall health, unable to tolerate surgery;
  • Preoperative anesthetic assessment indicates inability to tolerate general anesthesia;
  • Presence of other neurological or psychiatric disorders;
  • Severe bleeding tendency due to coagulopathy;
  • Inability to comply with treatment and follow-up;
  • Other conditions that preclude tolerance to surgery.

Treatment and study plan

Lymphaticovenous Anastomosis

Procedure

The basic principle of LVA surgery is to anastomose the deep cervical lymphatic vessels of the brain with adjacent small veins, effectively enabling the direct reflow of accumulated Aβ and tau proteins in the brain's lymphatic circulation into the venous system, thereby improving the symptoms of Alzheimer's Disease (AD).

Primary outcomes

  1. The assessment of score changes after Lymphaticovenous Anastomosis(LVA) for the treatment of Alzheimer's Disease(AD) using Mini-Mental State Examination(MMSE).

    Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months,1 year, 3 years, 5 years.

    The assessment of score changes by Mini-Mental State Examination(MMSE)

Secondary outcomes

  1. The safety of Lymphaticovenous Anastomosis(LVA) for the Treatment of Alzheimer's Disease(AD)

    Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months, 1 year, 3 years, 5 years.

    The complications associated with LVA treatment for AD, including perioperative complications and long-term complications.

Other outcomes

  1. The mechanism of LVA treatment for AD patients

    Time frame: From enrollment to the end of treatment at 3 days, 7 days, 1 month, 3 months, 6 months, 1 year, 3 years, 5 years.

    The changes occur in AD-related biomarkers（Aβ42、 Aβ40、Aβ42/40、pTau217、pTau181） before and after surgery.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Clinical Study on the Safety, Efficacy, and Mechanisms of Lymphaticovenous Anastomosis (LVA) for the Treatment of Alzheimer's Disease (AD)

Acronym: LVA; AD

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.