Alzheimer's Disease Treated With Vagus Nerve Stimulation
ConditionAlzheimer Disease (AD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorBeijing Municipal Administration of Hospitals
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: 50-80 years
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)]
There is mild to moderate cognitive impairment, and the clinical cognitive rating scale [Clinical Dementia Rating (CDR)] score is 0.5-2.
Stable use of the drug for more than 1 month, and no plan to change the medication within 6 months after randomization
Disqualifiers
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.
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.
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vagus Nerve Stimulation
DeviceAfter 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.
Sham Vagus Nerve Stimulation
DeviceAfter 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.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Vague nerve stimulation groupExperimental treatment 1 intervention
Group B: Sham VNS groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in ADAS-Cog 14 Score
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 14-item total score. The ADAS-Cog assesses the severity of cognitive symptoms of Alzheimer's disease. Higher scores indicate greater cognitive impairment. Change is calculated as the score at a given timepoint minus the score at baseline.
Time frame
Baseline, 6 Months Post-randomizationSecondary outcomes
1
Change From Baseline in MMSE Score
Change from baseline in the Mini-Mental State Examination (MMSE) score. Assesses global cognitive function. Scale ranges from 0 to 30; higher scores indicate better cognitive function. Change = Score at Timepoint - Score at Baseline.
Time frame
Baseline, 6 Months Post-randomization2
Change From Baseline in AVLT Scores
Change from baseline in the Auditory Verbal Learning Test (AVLT) scores. Assesses verbal learning and memory. Key sub-scores assessed include immediate recall (sum of trials 1-5) and delayed recall. Scale ranges from 0 to 84; higher scores indicate better cognitive function.Change = Score at Timepoint - Score at Baseline.
Time frame
Baseline, 6 Months Post-randomization3
Change From Baseline in CDR-SB Score
Change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score. Assesses dementia severity across 6 domains (Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, Personal Care). Scores range from 0 to 18; higher scores indicate greater impairment. Change = Score at Timepoint - Score at Baseline.
Time frame
Baseline, 6 Months Post-randomization4
Change From Baseline in CDR-GS Score
Change from baseline in the Clinical Dementia Rating - Global Score (CDR-GS). Provides an overall dementia severity stage (0=Normal, 0.5=Questionable, 1=Mild, 2=Moderate, 3=Severe) based on cognitive and functional performance. Change = Score at Timepoint - Score at Baseline.
Time frame
Baseline, 6 Months Post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Municipal Administration of Hospitals
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Source ClinicalTrials.gov