An Exploratory Study of Deep Cervical Lymphovenous Bypass (LVB) in Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

An Exploratory Study of Deep Cervical Lymphovenous Bypass (LVB) in Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448975
• Other study ID #: AHJiangnanluhua
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2024
• Source: Affiliated Hospital of Jiangnan University
• Contact: Lu Hua
• Phone: 08615301516197
• Email: luhua1969[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the safety and efficacy of "deep cervical lymphovenous bypass" in the treatment of Alzheimer's disease

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The age ranged from 60 to 80 years, and the time from initial diagnosis to enrollment was more than 12 months

2. The estimated survival time is more than 12 months;

3. The clinically diagnosed AD patients with moderate to severe GDS score;

4. The imaging examination has the correlation diagnosis evidence;

5. Volunteer to participate in the project and sign an informed consent form with the guardian.

Exclusion Criteria:

1. The patients with severe heart and lung diseases, such as myocardial infarction, heart failure, emphysema and pulmonary infection;

2. The patients who can not tolerate general anesthesia;

3. The patients with hypertension or blood coagulation disorder or liver and kidney dysfunction that are poorly controlled by drugs;

4. The pregnant women;

5. The patients with neck skin infection;

6. Those who could not complete the evaluator/those who refused to complete the one-year clinical follow-up.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Procedure:
• Cervical Lymphovenous Bypass: Lymphaticovenous end-to-side anastomosis
Lymphaticovenous anastomosis: The lymphaticovenous anastomosis is performed under a binocular surgical microscope with magnification of 30 to 50 times, specifically for cervical lymphatics and veins with diameters of 0.2-0.5mm. The specific operative technique is as follows: End-to-side lymphaticovenous anastomosis: The diameters of the end-to-side anastomosis for the vein and lymphatic vessel are 0.5 mm and 0.2 mm, respectively. After occluding the blood flow with a vascular clamp, an incision is made on one side of the venous wall in a 300-degree angle towards the direction of the heart. The length of the lymphatic vessel is further trimmed, and lymphatic leakage is observed after trimming. The distal end of the lymphatic vessel is anastomosed end-to-side using 11-0 sutures placed at equal intervals with six stitches. After the anastomosis, the venous clamp is released to check for any leakage.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiangnan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET scan	Detecting changes in the brain's amyloid and tau protein burden before and after surgery.Tau-PET can reflect the abnormal deposition of tau protein in the brains of Alzheimer's Disease (AD) patients and is closely related to the severity of AD's clinical symptoms. A positive tau-PET result is helpful in confirming the diagnosis of AD.The procedure of tau-PET includes patient preparation, radiotracer injection, PET image acquisition, correction, reconstruction, and fusion, among other steps. The performance of tau-PET at these stages is as follows: 1. Initial stage: tau-PET negative. 2. Early stage: tau deposition in the medial temporal lobe. 3. Middle stage: moderate neocortical tau deposition. 4. Late stage: severe neocortical tau deposition.	1 year
Primary	Plasma Aß1-42 and plasma p-tau181	Elevated preoperatively, postoperatively the indicators have decreased, with reference values being plasma Aß1-42 = 110.00 pg/mL; plasma p-tau181 = 30.00 pg/mL.	1 year