Alzheimer Disease (AD)AdvantNCT06923007
Alzheimer's Disease Treated With Vagus Nerve Stimulation
A study testing Vagus Nerve Stimulation in people with Alzheimer Disease (AD), run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease (AD)
- What is being tested?
- Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- The informed consent form is signed, and the patient complies with the requirements.
Who cannot join
- 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.
- Subjects who are judged by the investigator to have suicidal tendencies
- Illiteracy or insufficient education to complete the scale assessment
Show all 16Show fewer
- Having a history of alcohol or drug abuse (excluding smoking history) within 2 years prior to the screening visit
- 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
- 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)
- 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
- Any MRI contraindications, including claustrophobia, or the presence of prohibited metal (ferromagnetic) implant/cardiac pacemakers
- There are contraindications for VNS surgery, such as left vagus nerve injury, severe infection at the surgical site, and severe heart, lung, liver, kidney or other system dysfunction that cannot tolerate general anesthesia surgery.
- Currently participating in other interventional clinical trials, or any other type of medical research that is considered scientifically or medically incompatible with this study
- Other reasons that hinder the completion of this study, such as lack of stable caregivers
- Female subjects who are pregnant or planning to become pregnant
- Research center staff members and/or their immediate family members directly related to this study. Immediate family members are spouses, parents, children, or siblings, whether biological or legally adopted relatives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, 100070
Rujin Wang, +86 18101287707, 644848346@qq.com
About this study
Official title: 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
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.
Read more
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)
- Being tested
- Vagus Nerve Stimulation, Sham Vagus Nerve Stimulation
- Keywords
- VNS, vagus nerve stimulation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve StimulationDevice
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.
Sham Vagus Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vague nerve stimulation group | Experimental | Participants receive active vagus nerve stimulation (VNS) for 6 months. Receives: Device: Vagus Nerve Stimulation |
| Sham VNS group | Sham comparator | Participants receive sham vagus nerve stimulation for 6 months. Receives: Device: Sham Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 Months Post-randomization
Secondary outcomes (7)
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.
Measured: Baseline, 6 Months Post-randomization
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.
Measured: Baseline, 6 Months Post-randomization
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.
Measured: Baseline, 6 Months Post-randomization
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.
Measured: Baseline, 6 Months Post-randomization
Change From Baseline in HAMA Score
Change from baseline in the Hamilton Rating Scale for Anxiety (HAMA) total score. Assesses the severity of anxiety symptoms across 14 items. Higher scores indicate greater anxiety. Change = Score at Timepoint - Score at Baseline.
Measured: Baseline, 6 Months Post-randomization
Change From Baseline in MAES Score
Change from baseline in the Modified Apathy Evaluation Scale (MAES) score. Assesses the severity of apathy. Higher scores indicate greater apathy. Change = Score at Timepoint - Score at Baseline.
Measured: Baseline, 6 Months Post-randomization
Change From Baseline in ADCS-ADL Score
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Inventory score. Assesses patient functional ability in activities of daily living based on caregiver report. Higher scores indicate better functional ability. Change = Score at Timepoint - Score at Baseline.
Measured: Baseline, 6 Months Post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start7 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, double-blind, placebo, parallel control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhang Jianguo, Beijing Tiantan Hospital
- Investigators
- Jianguo Zhang, MD, Principal investigator, Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaWei Zhang, MD, Principal investigator, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923007
- Sponsor's protocol ID
- ZLRK202313
- Acronym
- Advant
- Status last verified
- Jun 2025
- First submitted
- 9 Apr 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06923007
- Acronym / sponsor ID
- Advant / ZLRK202313
- Conditions
- Alzheimer Disease (AD)
- Keywords
- VNS, vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Study start
- 7 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized, double-blind, placebo, parallel control trial
| Arm | Type | Receives |
|---|---|---|
| Vague nerve stimulation group | Experimental | Device: Vagus Nerve StimulationParticipants receive active vagus nerve stimulation (VNS) for 6 months. |
| Sham VNS group | Sham comparator | Device: Sham Vagus Nerve StimulationParticipants receive sham vagus nerve stimulation for 6 months. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- The informed consent form is signed, and the patient complies with the requirements.
Key exclusion criteria (16 listed)
- 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.
- Subjects who are judged by the investigator to have suicidal tendencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve StimulationAfter 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 | Vague nerve stimulation group |
| Sham Vagus Nerve StimulationAfter 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. | Device | Sham VNS group |
Primary outcome
Change From Baseline in ADAS-Cog 14 Score
Time frame: Baseline, 6 Months Post-randomization
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.
7 secondary outcomes
Change From Baseline in MMSE Score
Time frame: Baseline, 6 Months Post-randomization
Change From Baseline in AVLT Scores
Time frame: Baseline, 6 Months Post-randomization
Change From Baseline in CDR-SB Score
Time frame: Baseline, 6 Months Post-randomization
Change From Baseline in CDR-GS Score
Time frame: Baseline, 6 Months Post-randomization
Change From Baseline in HAMA Score
Time frame: Baseline, 6 Months Post-randomization
Change From Baseline in MAES Score
Time frame: Baseline, 6 Months Post-randomization
Change From Baseline in ADCS-ADL Score
Time frame: Baseline, 6 Months Post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianguo Zhang, MD principal investigator
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Wei Zhang, MD principal investigator
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation in people with Alzheimer Disease (AD), run by Beijing Municipal Administration of Hospitals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rujin Wang (+86 18101287707, 644848346@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in ADAS-Cog 14 Score (time frame: Baseline, 6 Months Post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.