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Alzheimer's Disease Treated With Vagus Nerve Stimulation | Clinical Trials | Clareo Health

RECRUITINGNA

Alzheimer's Disease Treated With Vagus Nerve Stimulation

Study on the Safety and Efficacy of VNS in the Treatment of Mild and Moderate AD Patients; a Multi-center, Randomized, Double-blind, Placebo Parallel Control Trial

NCT06923007•Beijing Municipal Administration of Hospitals

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of vagus nerve stimulation (VNS) for treating Alzheimer's disease (AD) in patients aged 50-80 years with mild cognitive impairment to moderate Alzheimer's disease. The main questions it aims to answer are: Is the change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) score at 6 months post-randomization better in the VNS group compared to the sham stimulation group? Is the change from baseline in scores of other cognitive function, neuropsychiatric symptom, or activities of daily living scales at 6 months post-randomization better in the VNS group compared to the sham stimulation group? Researchers will compare the group receiving vagus nerve stimulation (active VNS group) and the group receiving sham vagus nerve stimulation (sham VNS group) to see if VNS is more effective in improving cognitive function, neuropsychiatric symptoms, or activities of daily living. Participants will: Undergo screening assessments (including medical history, physical exams, cognitive and behavioral scale assessments, imaging, etc.). Undergo surgery for VNS device implantation. Be randomized to either the active VNS or sham VNS group and receive the corresponding stimulation treatment for 6 months (while continuing standard AD medication). Attend multiple follow-up visits during the study (baseline, randomization day, 3 months, and 6 months post-randomization) for clinical scale assessments. Potentially provide biological samples (blood, CSF) and undergo additional auxiliary examinations (e.g., MRI, EEG, PET) at specific time points.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 50-80 years
•2. Subjects conform to the diagnostic criteria for AD established by the National Institute on Aging and the Alzheimer's Association \[National Institution Aging and Alzheimer's Association (NIA-AA)\]
•3. There is mild to moderate cognitive impairment, and the clinical cognitive rating scale \[Clinical Dementia Rating (CDR)\] score is 0.5-2.
•4. Stable use of the drug for more than 1 month, and no plan to change the medication within 6 months after randomization
•5. The informed consent form is signed, and the patient complies with the requirements.

Exclusion Criteria

•1. Dementia caused by other reasons, including vascular dementia, central nervous system infections (such as AIDS, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, dementia with Lewy bodies, traumatic brain injury dementia, other physical and chemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), significant physical illnesses (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (such as subdural hematoma, brain tumor), endocrine system disorders (such as thyroid disease, parathyroid disease), and dementia due to vitamin deficiency or any other cause.
•2. The presence of a serious or unstable disease, including cardiovascular, liver, kidney, gastrointestinal, respiratory, endocrine, neurological (AD-derived cognitive impairment excluded), psychiatric, immune or blood disorders, and other diseases that the investigator considers may affect the analysis results of this study, or life expectancy \< 24 months.
•3. A history of cancer within 5 years, except for non-metastatic basal cell carcinoma and/or squamous cell carcinoma, cervical carcinoma in situ, non-progressive prostate cancer, or other cancers with low risk of recurrence or spread.
•4. The subject has been diagnosed with any primary mental disorder other than AD-related cognitive impairment. If the investigator deems that the presence of this mental disorder or symptom may affect the interpretation of VNS efficacy, cognitive assessment, or the subject's ability to complete the study, then the subject imust be excluded. Subjects with a history of schizophrenia or other chronic psychiatric conditions are also excluded.
•5. Subjects who are judged by the investigator to have suicidal tendencies
•6. Illiteracy or insufficient education to complete the scale assessment
•7. Having a history of alcohol or drug abuse (excluding smoking history) within 2 years prior to the screening visit
•8. A history of multiple or severe drug allergy, obvious atopic allergic constitution or severe hypersensitivity after treatment (including but not limited to severe polymorphic erythema, linear IgA dermatosis, toxic epidermal necrolysis and/or exfoliative dermatitis) with clinical significance
•9. Important abnormalities that may be clinically significant and harmful to the subject, affect the study, or suggest other evidence of etiology of dementia during screening, such as physical examination or neurological examination, vital signs, ECG or clinical laboratory test results (determined by the investigator)
•10. Screening MRI results showing significant abnormalities suggest another potential cause of progressive cognitive impairment, or findings with clinical significance that may affect the participants ability to safely participate in the study. For example, more than two infarcts larger than 2 cm in diameter, infarcts in critical areas such as the thalamus, hippocampus, internal olfactory cortex, parahippocampal cortex, angular gyrus, or other gray matter nuclei in the subcortical regions, as well as a score of \> 2 on the Fazekas Scale
+6 more criteria

Locations (1)

Beijing Tiantan Hospital

Beijing, China

Key Dates

Start Date

May 7, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

June 6, 2025

Enrollment

ESTIMATED participants

Conditions

Alzheimer Disease (AD)

Interventions

Vagus Nerve Stimulation

DEVICE

Sham Vagus Nerve Stimulation

DEVICE

Contacts

Rujin Wang

CONTACT

+86 18101287707 644848346@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Alzheimer's Disease Treated With Vagus Nerve Stimulation

Inclusion Criteria

Exclusion Criteria

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