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.
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.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Huangpu |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07680660 on ClinicalTrials.gov ↗ ← All trials in China