Alzheimer's Disease
Conditions
Interventions
Experimental group:Deep Cervical Lymphaticovenous Anastomosis
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the clinical diagnostic criteria for dementia of AD origin in the 2024 edition of the AA (2) Age 50-80 years (including the cut-off value), of which patients younger than 65 years need AD biological markers to confirm the diagnosis; (3) MMSE score <= 26; (4) No improvement in clinical symptoms for more than six months of drug treatment; (5) No serious heart, liver, kidney and other systemic diseases; (6) ASA anaesthesia assessment grading can tolerate the surgery and can cooperate with the completion of all examinations and surgeries required for the study; (7) Patients or guardians voluntarily participate in this study. If the patient has mild AD and can understand and cooperate, the patient himself/herself will be told to explain the surgical procedure, expected results and possible benefits and risks, and sign the informed consent form. If the subject moderately or severely cannot understand and cooperate and is unable to sign in person, the patient's guardian will be given a detailed explanation of the surgical procedure, expected effects, and possible benefits and risks, and the guardian will sign the informed consent form in his/her place.cannot understand and cooperate and cannot sign in person, the patient's guardian will be given a detailed explanation of the surgical procedure, expected effects, and possible benefits and risks, and the guardian will sign the informed consent form in his/her place.
Exclusion criteria
Exclusion criteria: (1) Contraindications to surgery or anaesthesia, such as coagulation disorders (platelet counts 100 × 109/L, INR > 1.4; severe hepatic impairment, ALT 3 times the upper limit of normal, or AST 3 times the upper limit of normal. Severe renal insufficiency, glomerular filtration rate less than 30ml/min/1.73m^2 (2) History of intracranial haemorrhage or craniocerebral trauma within the last 1 year; (3) Presence of a history of internal bleeding, such as gastrointestinal bleeding, genitourinary bleeding, and respiratory bleeding not completely controlled; (4) Myocardial infarction or atrial fibrillation within the last 30 days; (5) Those with severe cerebrovascular pathology; (6) Those with drug or alcohol abuse or dependence; (7) Allergy to surgery-related drugs, instruments, or screening contrast agents; (8) Advanced stages of any disease with a life expectancy of less than 180 days; (9) Has undergone similar surgery or treatment in the recent past; (10) Ongoing participation in other clinical trials (excluding: observational studies not involving interventions, natural history and/or epidemiologic studies); (11) Other patients who have been assessed as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Aß-positive Centiloid in PET/CT at preoperative and 6 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in P-Tau217 protein expression in peripheral blood before and 6 months after surgery;Changes in MMSE/MoCA scale scores, preoperatively and 6 months postoperatively;Safety indicators: infection, anastomotic stenosis or occlusion, nerve injury; | — |
Countries
China
Contacts
Public ContactYoubai Chen
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed