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

NCT06706947 | Not Yet Recruiting DMC

• 1 other identifier: SSYLL-KY-20241002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Does deep Lymphaticovenous Anastomosis lead to changes in peripheral blood biomarker levels, neuroinflammatory responses, and neuroimaging in patients with Alzheimer's dementia?

Conditions

Alzheimer's Disease (AD)

Keywords

Lymphaticovenous Anastomosis; cognitive function; therapeutic efficacy; Mechanism; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Mini-Mental State Examination(MMSE)

  half a year

Study Arms (1)

Lymphaticovenous Anastomosis

EXPERIMENTAL

Procedure: Lymphaticovenous Anastomosis

Interventions

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."

Also known as: LVA

Lymphaticovenous Anastomosis

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luo Xinxin: lead
• Shenzhen Bao'an People's Hospital: collaborator
• Shenzhen Kangning Hospital: collaborator

Study Sites (1)

Zhongshan Third People's Hospital

Shenzhen, China

Location

Related Publications (20)

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Central Study Contacts

Xinxin Luo

CONTACT

19917731027; 1213895523@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 27, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

CN (1)