NCT07094438

Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Alzheimer's Disease

Study Safety and Efficacy of Deep Brain Stimulation (DBS) and Cervical Deep Lymphoid-venous Anastomosis (LVA) in Patients With Severe Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate the safety of deep brain stimulation (DBS) and cervical deep lymphoid-venous anastomosis (LVA) in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of DBS and LVA in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function, emotion and life quality in patients with severe AD.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
PROCEDURE	Deep Brain Stimulation, DBS	Deep brain stimulation (DBS) is performed after preoperative MRI and CT images are fused in a planning system to determine the target and trajectory. Under general anesthesia, electrodes are precisely implanted into the fornix or nucleus basalis of Meynert using a stereotactic frame or neurosurgical robot. The electrodes are inserted through a burr hole in the patient's skull and connected to a pulse generator placed subcutaneously in the chest. Optimal stimulation parameters for Alzheimer's disease are not yet established. For fornix targets, settings are typically 3-3.5 V, \~130 Hz, 90 μs; for nucleus basalis targets, 2-4.5 V, 10-20 Hz, 90-150 μs, adjusted according to anatomical features and intraoperative responses.
PROCEDURE	Deep cervical lymphatic-venous anastomosis, LVA	Cervical deep lymphaticovenous anastomosis (LVA) microsurgically connects deep cervical lymphatic vessels to adjacent veins, promoting drainage of brain-derived amyloid-β and tau into the venous system and potentially alleviating Alzheimer's disease symptoms. The minimally invasive neck procedure involves small incisions and high-magnification suturing of lymphatics and veins with ultra-fine (11-0 or 12-0) sutures, creating multiple anastomoses to enhance brain lymphatic outflow.
DRUG	Recognized pharmacological treatments for AD.	Patients in the medication group received only the currently recognized pharmacological treatments for AD, including Memantine Hydrochloride and Donepezil.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-06-01
• Completion: 2027-07-01
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: China