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NCT Number: NCT06706947

Exploration of the Efficacy and Mechanisms of Lymphaticovenous Anastomosis in the Treatment of Alzheimer's Disease

The aim of this clinical trial is to determine whether Lymphaticovenous Anastomosis can treat Alzheimer's disease，in AD patients aged 18-80.he main questions it aims to answer are:

1. Can Lymphaticovenous Anastomosis improve cognitive function, daily living ability, mood, or sleep status in patients with Alzheimer's dementia, demonstrating good therapeutic efficacy? 2. Does deep Lymphaticovenous Anastomosis lead to changes in peripheral blood biomarker levels, neuroinflammatory responses, and neuroimaging in patients with Alzheimer's dementia?

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Key information

Conditions

Alzheimer's Disease (AD)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least two deputy chief physicians or above, diagnosed with Alzheimer's dementia according to the DSM-5 diagnostic criteria;
  • Age between 18-80 years old;
  • The course of the disease is at least 1 year;
  • MMSE score ≤ 24 points; MoCA score < 26
  • Brain MRI shows hippocampal atrophy;
  • Patients and their families agree to participate in this project for surgical treatment and sign an informed consent form.

Exclusion criteria

  • Individuals with contraindications for Lymphaticovenous Anastomosis; those allergic to anesthetics and contrast agents (indocyanine green);
  • Those unable to cooperate with cranial magnetic resonance imaging and scale testing;
  • Patients simultaneously suffering from schizophrenia, depression, bipolar disorder;
  • Patients with severe somatic diseases (such as cardiovascular, liver, kidney, gastrointestinal, etc.), infectious diseases, and immune system disorders;
  • Individuals with serious neurological diseases (such as epilepsy, cerebrovascular diseases, etc.), other types of dementia, mental retardation;
  • Pregnant or lactating women.

Treatment and study plan

Lymphaticovenous Anastomosis

Procedure

Lymphaticovenous Anastomosis (LVA) is an emerging super-microsurgical procedure pioneered by Professor Xie Qingping and his team, a group of Chinese microsurgery experts. This technique has been published in the official journal of the American Society of Plastic Surgeons (ASPS), confirming its effectiveness in improving the "drainage" function of the brain and reducing lymphatic pressure in deep brain tissues. By establishing an anastomosis between lymphatic vessels and veins in the neck, the surgery enhances the drainage of cerebrospinal fluid, alleviating the accumulation of toxins and waste within the brain, thereby easing the symptoms of Alzheimer's disease. Due to its significant contribution to the field of microsurgery, this innovative surgery has been selected as one of the "Top Seven Advances in Microsurgery for 2022."

Other names: LVA

Primary outcomes

  1. Mini-Mental State Examination(MMSE)

    Time frame: half a year

Study contacts

Contact information is provided by the study sponsor or research team.

Xinxin Luo

CONTACT

[email protected]

19917731027

Sponsors and collaborators

Lead sponsor

Luo Xinxin

Other

Collaborators

  • Shenzhen Baoan District People's Hospital
  • Shenzhen Kangning Hospital

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

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.

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