Alzheimers disease
Conditions
Interventions
Intervention Group:Deep-lymphatic vein anastomosis of neck
Sponsors
China-Japan Union Hospital of Jilin University Committee
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Patients must meet the diagnostic criteria for moderate to severe Alzheimer's disease (AD) established by the National Institute on Aging and the Alzheimer's Association (NIA - AA) in 2024. Their Clinical Dementia Rating (CDR) score should range from 2 to 3, and their Mini - Mental State Examination (MMSE) score should be between 10 and 20. 2.Patients should have received regular drug treatment (such as acetylcholinesterase inhibitors) for at least 6 months with poor efficacy. This indicates at regular drug treatment has limited effectiveness in controlling the disease in these patients, and new treatment methods need to be explored. 3.Patients should test positive for Pittsburgh Compound B (PIB) in Alzheimer's disease PET - CT diagnosis, or their cerebrospinal fluid markers should support the diagnosis of AD. 4.Patients should be aged between 55 and 85 years old, and their American Society of Anesthesiologists (ASA) physical status classification should be I - II. This ensures that patients can tolerate the surgical and anesthetic procedures. 5.Neck vascular ultrasound should show that the internal jugular vein is unobstructed to guarantee the normal progress of the surgery and smooth lymphatic return pathway after the operation.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of head - and - neck surgery/radiotherapy, recent neck skin and soft - tissue infections, and abnormal coagulation function (International Normalized Ratio, INR > 1.5) will be excluded. A history of head - and - neck surgery/radiotherapy may lead to changes in the local anatomical structure, affecting the surgical operation and outcome. Recent neck skin and soft - tissue infections may cause non - healing of the surgical incision and spread of the infection after surgery. Abnormal coagulation function will increase the risk of surgical bleeding, endangering the patient's life safety. 2.Patients who are unable to tolerate surgery based on pre - operative assessment. 3.Patients with recent new - onset cerebral infarction, myocardial infarction, cerebral hemorrhage, or gastrointestinal bleeding. 4.Patients with a risk of cerebral amyloid angiopathy - related cerebral hemorrhage (MRI shows >= 2 microbleeds) are not suitable to participate in this study. Such patients have a relatively high risk of cerebral hemorrhage during or after the operation, which may affect the judgment of the study results and cause serious harm to the patients. 5.Patients with a cerebrospinal fluid shunt device in the body or those who have participated in other interventional studies recently (< 6 months) will be excluded. The cerebrospinal fluid shunt device may interfere with the detection of cerebrospinal fluid metabolism - related indicators in this study. Recent participation in or interventional studies may affect the patient's condition and the accuracy of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Clinical Dementia Rating Scale score (CDR-SB) at 6 months postoperatively;Blood biomarkers Aß42/p-tau181, p-tau 181, p-tau217;Incidence of serious adverse events (SAEs).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Alzheimer's Disease Assessment Scale MMSE/ADAS-cog 13 score;Diffusion tensor analysis (DTI - ALPS) index along the perivascular space;Cerebrospinal fluid Aß42/40, Aß42, p-tau 181/Aß42, t-tau/Aß42, p-tau 181, p-tau217;Neuroimaging; | — |
Countries
China
Contacts
Public ContactDu Jianshi
China-Japan Union Hospital of Jilin University Committee
Outcome results
None listed