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Alzheimer's Disease Treated With Vagus Nerve Stimulation

NCT06923007 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-06-06

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease (AD)

Interventions

DEVICE

Vagus 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.

DEVICE

Sham 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.

Sponsors & Collaborators

  • Beijing Municipal Administration of Hospitals

    lead OTHER_GOV

Principal Investigators

  • Jianguo Zhang, MD · Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  • Wei Zhang, MD · Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06923007 on ClinicalTrials.gov