Alzheimer's disease
Conditions
Interventions
Test Group:The closed loop nerve stimulator system was implanted and turned on 20 days (+/- 14 days) after operation
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. According to the NIA-AA diagnostic criteria established by the National Institute on Aging (NIA) and Alzheimer's Association (ADA) in 2011, patients with moderate AD were selected, and the neuropsychological evaluation conformed to MMSE = 50 years and <= 75 years, male or female; 3. Patients who were stable on cholinesterase inhibitors for at least 8 weeks before entering the study, and the dose of subsequent oral drugs was unchanged; 4. Hamilton Depression Rating Scale < 17 points, Hachinski Ischemia Rating Scale < 4 points; 5. Have enough proficiency in Chinese Mandarin and be able to complete the cognitive assessment scale; 6. Subjects and their families have reasonable expectations, voluntarily participate in this trial, and sign the written informed consent form; 7. No participation in other clinical trials within three months.
Exclusion criteria
Exclusion criteria: 1. Previous brain surgery, such as implantation DBS, stereotactic lesioning, cell transplantation, gamma knife, etc.; 2. Patients with contraindications to neurosurgery, as well as severe cardiovascular and cerebrovascular diseases; 3. Active implants in the body, such as a cardiac pacemaker, defibrillator, cochlear implant, drug infusion pump, other neurostimulators, etc.; or passive implants affecting the stimulator system; 4. Clinically significant or unstable physical conditions (including alcohol and/or drug abuse) or progressive central nervous system diseases; 5. Combined with severe abnormal liver and kidney function and other systemic diseases that seriously affect health; 6. The subjects with poor compliance judged by the investigator or not suitable for participating in the clinical trial; 7. Women who are pregnant or have the intention to become pregnant in the past year, lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ADAS-Cog scale score was assessed 180 days after surgery and compared with baseline to evaluate the improvement of cognitive function; | — |
Secondary
| Measure | Time frame |
|---|---|
| The scores of MMSE and MoCA were assessed 180 days after operation, and compared with the baseline to evaluate the improvement of cognitive function;Hamilton Depression Rating Scale, Pittsburgh Sleep Quality Index and Activities of Daily Living Scale were assessed 180 days after operation, and compared with baseline to evaluate the improvement of mood, sleep and life ability;FDG-PET was performed 180 days after surgery and compared with baseline to evaluate the improvement of glucose metabolism in different brain regions;Investigator evaluation of the operational performance of the device;Evaluation on the service performance of device by subjects; | — |
Countries
China
Contacts
Public ContactYuping Wang
Xuanwu Hospital Capital Medical University
Outcome results
None listed