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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06448975
Other study ID # AHJiangnanluhua
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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