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NCT07680660

Efficacy of Lymphatic-Venous Anastomosis Plus Donepezil Versus Donepezil Alone for Alzheimer's Disease

Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

View on ClinicalTrials.gov

Summary

This study employed a multicenter, randomized controlled trial (RCT) design to evaluate the efficacy and safety of deep cervical lymphatic/lymph node-venous anastomosis combined with oral donepezil compared to donepezil monotherapy in patients with Alzheimer's disease and moderate dementia. Participants were randomized using a central randomization system with stratified block design, with the study center and age group (50-64 years, 65-80 years) as stratification factors. While study participants and surgical investigators could not be blinded due to the nature of the intervention, efficacy assessors and imaging specialists remained blinded to ensure the objectivity and reliability of the findings. The intervention group received deep cervical lymphatic/lymph node-venous anastomosis (detailed surgical procedure is specified in the protocol) in combination with oral donepezil (5-10 mg/day), while the control group received oral donepezil alone. The total treatment and follow-up period was 18 months, with assessments conducted at baseline, 1 week, 1, 3, 6, 12, and 18 months post-operation. These included neuropsychological evaluations (MMSE, MoCA, CDR, BADL, IADL, NPI, AES), neuroimaging (MRI, PET, ultrasound), fluid biomarker analyses (CSF and blood levels of Aβ, Tau, neuroinflammatory factors, etc.), and safety monitoring. The primary efficacy endpoint was the change in CDR-SB score at 12 months post-treatment. Secondary endpoints included changes in multiple cognitive scales, neuroimaging metrics, and biomarkers at 18 months. Safety indicators encompassed adverse event recording, vital signs, and laboratory tests.

Official title: A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Cervical Lymph Vessel/Node-venous Anastomosis Combined With Donepezil Versus Donepezil Alone in the Treatment of Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-07-15

Completion Date

2029-03-31

Last Updated

2026-07-02

Healthy Volunteers

Conditions

Alzheimer s Disease

Interventions

PROCEDURE

Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil

Under total intravenous anesthesia, the patient is placed supine with the head turned and shoulders elevated. A transverse neck incision is made, the platysma is opened, and the external jugular vein and great auricular nerve are exposed and protected. Dissection proceeds along the sternocleidomastoid muscle and carotid sheath to create two lymphatic composite flaps: a lateral IIB/III flap rich in deep cervical lymph nodes and lymphatic vessels, and a medial IIA flap containing the angular lymph node. Both flaps are prepared to ensure continuous lymphatic fluid outflow. Revascularization is then performed by end-to-end anastomosis of the IIA flap to a branch of the common facial vein or external jugular vein, and end-to-side anastomosis of the IIB/III flap to the internal or external jugular vein. After the anastomosis is completed, the incision is sutured layer by layer for cosmetic purposes.

DRUG

Oral treatment with donepezil

After randomly assigned into the group, the study participants were given donepezil orally (the cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil group began to take donepezil orally on the first day after operation, and the oral donepezil group began to take donepezil after completing the baseline examination), once a day, before sleep, starting at 5 mg/day, and adjusted to 10 mg/day after 6 weeks; if not tolerated, it will be maintained at 5 mg/day, continued for 6 weeks, and then 10 mg/day will be attempted again, with continuous administration for 18 months. If research participants still cannot tolerate the high dose, they may be maintained at 5 mg/day for 18 months.

Inclusion Criteria 1. The patient or guardian signs the informed consent form; 2. Age 50-80 years (≥50 years, ≤80 years), male or female; 3. The first diagnosis is Alzheimer's disease with dementia; 4. MMSE score ≤24; 5. Positive β-amyloid protein PET imaging findings; 6. HAMD score ≤17; 7. Hachinski score ≤7; 8. No AD-related drug treatment has been received within the past 1 month; 9. ASA grade 1-3 (≥ grade 1, ≤ grade 3). 10. CDR-SB score of 9.5-15.5 Exclusion Criteria 1. Presence of contraindications to MRI, ICG angiography, or PET scan; 2. Presence of contraindications to lumbar puncture; 3. Severe heart disease or unstable hemodynamic status; 4. Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months; 5. Hepatic insufficiency, AST or ALT \>3 times the upper limit of normal; 6. Renal insufficiency, GFR \<60 mL/min or need for blood purification treatment; 7. MRI indicates active or acute intracranial lesions, including intracranial infection, space-occupying lesions, major hemorrhage, and ≥4 lobar microbleeds, etc.; 8. History of cerebral hemorrhage or cerebral infarction with severe residual neurological dysfunction; 9. Blood diseases, bleeding/coagulation disorders, coagulation dysfunction; 10. Abnormal thyroid function; 11. Moderate or severe stenosis of intracranial or cervical vessels with severe residual neurological dysfunction; 12. Severe hypertension not effectively controlled, systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; 13. The disease requires systemic use of steroids; 14. Drug addiction (including alcohol, narcotics, and alcohol dependence); 15. Severe infectious diseases, including HIV positivity, severe infection, etc.; 16. Severe psychiatric disease or potential suicide risk; 17. Within 3 years after radical surgery for malignant tumor; 18. Participation in other interventional clinical trials within the past three months; 19. In the physician's judgment, poor compliance, inability to complete, or unwillingness to cooperate with regular postoperative follow-up; 20. Other circumstances that the physician considers unsuitable for this clinical trial. 21. Anti-Aβ monoclonal antibody treatment has been received within half a year

Locations (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Huangpu, China