RecruitingNot ApplicableNCT06923007

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


Sponsor

Beijing Municipal Administration of Hospitals

Enrollment

74 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vagus nerve stimulation (VNS) — gentle electrical pulses delivered to the vagus nerve — can slow down memory and thinking decline in people with Alzheimer's disease. VNS is already used to treat epilepsy and depression. **You may be eligible if...** - You are between 50 and 80 years old - You have a diagnosis of Alzheimer's disease - You have mild to moderate cognitive decline (CDR score 0.5 to 2) - Your medication has been stable for more than 1 month and is not expected to change in the next 6 months **You may NOT be eligible if...** - Your dementia is caused by something other than Alzheimer's (such as vascular dementia or Parkinson's disease) - You have a pacemaker or other implanted electrical device - You have severe heart or respiratory conditions that could be affected by VNS - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVagus Nerve Stimulation

After randomization, VNS is performed for 6 months. The stimulation parameters will be 30 Hz and 250 μs, the maximum tolerable current is selected according to the patients' adverse reactions (dizziness, palpitations, abnormal sensations, local pain, etc.), and the recommended treatment intensity is 0.8 mA.

DEVICESham Vagus Nerve Stimulation

After randomization, sham vagus nerve stimulation VNS treatment is performed for 6 months. The stimulation parameters will be 30 Hz, 250 μs, and the treatment intensity will be 0 mA.


Locations(1)

Beijing Tiantan Hospital

Beijing, China

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NCT06923007


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