Actively Recruiting
Alzheimer's Disease Treated With Vagus Nerve Stimulation
Led by Beijing Municipal Administration of Hospitals · Updated on 2025-06-06
74
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alzheimer's Disease Treated With Vagus Nerve Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years
- Diagnosis of Alzheimer's disease according to National Institute on Aging and Alzheimer's Association criteria
- Mild to moderate cognitive impairment with Clinical Dementia Rating score between 0.5 and 2
- Stable Alzheimer's medication use for more than 1 month with no planned changes for 6 months after randomization
- Signed informed consent and willingness to follow study requirements
You will not qualify if you...
- Dementia caused by other diseases such as vascular dementia, infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic brain injury, or due to physical and chemical factors
- Serious or unstable diseases affecting major organs or life expectancy less than 24 months
- History of cancer within 5 years except certain low-risk cancers
- Primary mental disorders other than Alzheimer's cognitive impairment or chronic psychiatric conditions
- Suicidal tendencies
- Illiteracy or insufficient education to complete assessments
- History of alcohol or drug abuse within 2 years prior to screening
- Severe drug allergies or hypersensitivity reactions
- Clinically significant abnormalities in physical, neurological exams, vital signs, ECG, or lab tests
- MRI findings suggesting other causes of cognitive impairment or significant abnormalities
- Contraindications to MRI or VNS surgery including metal implants, severe infections, or organ dysfunction
- Participation in conflicting clinical trials
- Lack of stable caregivers
- Pregnant or planning pregnancy
- Staff or immediate family members involved in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China, 100070
Actively Recruiting
Research Team
R
Rujin Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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