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

November 25, 2024 updated by: Luo Xinxin

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shenzhen, China
        • Zhongshan Third People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lymphaticovenous Anastomosis
Procedure: Lymphaticovenous Anastomosis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mini-Mental State Examination(MMSE)
Time Frame: half a year
half a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luo Xinxin

Collaborators

Shenzhen Kangning Hospital
Shenzhen Bao'an People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSYLL-KY-20241002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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