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
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Meeting the diagnostic criteria for dementia formulated by the National Institute on Aging-Alzheimer's Association (NIA-AA).

• Clinical Dementia Rating (CDR) score of 3 points.

• Ability to ambulate independently or with the aid of a walker/cane.

• Adequate visual and auditory capacity to cooperate with examinations and treatment.

• Voluntary participation with written informed consent provided by both the subject and their legal guardian.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhiqi Mao, Ph.D
markmaoqi@126.com
8618910155994
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 98
Treatments
Experimental: DBS arm
Patients in the DBS group underwent deep brain electrode implantation, followed by cranial MRI and CT to verify the accuracy of electrode placement.
Experimental: LVA arm
Patients in the LVA group underwent LVA surgery, followed by cervical ultrasound and CT to assess the anastomosis.
Active_comparator: medication arm
Patients in the medication group received drug therapy only, without undergoing surgery.
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov