Alzheimer's disease
Conditions
Interventions
AD-VNS:VNS
Sponsors
Beijing Tiantan Hospital, Capital Medicine University
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Aged 50-80 years old; 2) Meet the diagnostic criteria for AD set by the National Institute on Aging and Alzheimer's Association (NIA-AA); 3) Clinical Dementia Rating (CDR) score of 0.5-2; 4) Stable medication use for =1 month, and no planned changes in medication within 6 months after randomization; 5) Signed informed consent, good compliance of the patient.
Exclusion criteria
Exclusion criteria: 1) Dementia caused by other reasons: vascular dementia, central nervous system infections caused by diseases such as HIV and syphilis, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic brain injury-induced dementia, physiologic factors such as drug or alcohol abuse, hepatic encephalopathy and pulmonary encephalopathy, endocrine system disorders such as thyroid and parathyroid diseases, as well as dementia caused by vitamin deficiency or any other reasons. 2) Currently having severe or unstable diseases, including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (excluding AD-related cognitive impairment), psychiatric, immune or hematologic diseases, or any other diseases that the investigator deems may affect the analysis results of this study, or life expectancy 2cm infarcts >2; infarcts in key areas such as thalamus, hippocampus, olfactory cortex, entorhinal cortex, angular gyrus, and other gray matter nuclei in the cortex and subcortex; Fazekas Scale score >2. 11) Any MRI contraindications, including claustrophobia, or the presence of prohibited (ferromagnetic) implants/pacemakers. 12) PET contraindications, such as tracer allergies, etc. 13) Currently or planning to be exposed to ionizing radiation, combined with the planned use of PET tracers in the study, which will result in cumulative exposure exceeding the recommended exposure limit. 14) VNS surgery contraindications, such as left vagus nerve injury, severe infection at the surgical site, severe cardiac, pulmonary, hepatic, renal, or other systemic functional abnormalities that cannot tolerate general an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE;Global Deteriorate Scale;Neuropsychiatric Inventory;ADCS-ADL;fMRI;PET-MRI;EEG; | — |
Countries
China
Contacts
Public ContactZhang Jianguo
Beijing Tiantan Hospital, Capital Medicine University
Outcome results
None listed