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

PHASE1RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

July 31, 2027

Conditions
Alzheimer Disease
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER