Vascular DementiaNCT07149038
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
A study testing Cerogrin in people with Vascular Dementia and Mild Cognitive Impairment, run by Neurogrin Inc. at 1 site in South Korea.
Trial summary
This clinical trial evaluates the preliminary effectiveness and safety of Cerogrin, a medical device developed by Neurogrin Inc. for auricular vagus nerve stimulation, in patients with vascular dementia or vascular mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 to 89 years
- Conditions the study is for
- Vascular Dementia, Mild Cognitive Impairment
- What is being tested?
- Cerogrin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2025to 30 Dec 2026
- 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 55 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 55 to 89 years.
- Diagnosed with vascular dementia or vascular mild cognitive impairment within 1 year before screening, with subcortical lesions confirmed on MRI.
- For both diagnoses:
- Severe white matter hyperintensity on MRI (Fazekas scale: deep white matter ≥ 2.5 cm or caps/bands ≥ 1.0 cm).
- Z-score < -1.0 SD in at least one cognitive domain (adjusted for education, age, and sex).
- For vascular dementia: independence in daily living impaired.
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- For vascular mild cognitive impairment: independence in daily living preserved.
- K-MMSE-II score ≥ 18 and CDR score 0.5 to 1.0 at screening.
- Stable cognitive-enhancing medication (if applicable) for ≥4 weeks before baseline.
- Availability of a caregiver (at least 8 hours/week contact).
- Females of childbearing potential: agreement to use medically acceptable contraception during the study.
- Provided written informed consent.
- Willingness to comply with study protocol.
Who cannot join
- Dementia other than vascular dementia (e.g., Alzheimer's disease, Lewy body dementia, frontotemporal dementia).
- Conditions causing cognitive decline (e.g., uncontrolled metabolic diseases, CNS infections, cerebrovascular disease, traumatic brain injury, Parkinson's disease).
- Severe psychiatric disorders (e.g., major depression, schizophrenia, substance abuse).
- Serious unstable physical conditions.
- MRI contraindications (e.g., claustrophobia, metal implants, contrast agent allergy).
- Auricular skin disease or condition preventing device use.
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- Inability to comply with study procedures.
- Pregnancy or breastfeeding.
- Participation in other clinical trials within 30 days before screening.
- Any other condition deemed inappropriate for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongtan Hallym University Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
About this study
Official title: A Single-Center, Randomized, Double-Blind Feasibility Trial Assessing the Initial Efficacy and Safety of Cerogrin, a Medical Device for Auricular Vagus Nerve Stimulation, in Improving Cognition in Patients With Vascular Dementia or Vascular Mild Cognitive Impairment: A Comparison With Sham Control
This clinical trial evaluates the preliminary effectiveness and safety of Cerogrin, a medical device developed by Neurogrin Inc. for auricular vagus nerve stimulation, in patients with vascular dementia or vascular mild cognitive impairment. Given the limited availability of effective pharmacological treatments for these conditions, the study aims to assess whether Cerogrin can enhance cognitive function through non-invasive neuromodulation.
Twenty-four participants will be randomized to receive either the active Cerogrin device or a sham (non-stimulating) device. Daily use will occur at home for 30 minutes over a four-week intervention period. The full study duration, including baseline assessments and follow-up, will span up to three months. During this period, cognitive function, neural activity, and safety outcomes will be systematically evaluated. This feasibility trial represents a critical step toward expanding therapeutic options for vascular cognitive impairment.
- Conditions
- Vascular Dementia, Mild Cognitive Impairment
- Being tested
- Cerogrin, Sham Device
- Medical subject headings
- Dementia, Vascular, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerogrinDevice
Participants in this arm will receive transcutaneous auricular vagus nerve stimulation using the Cerogrin device. This device non-invasively delivers electrical stimulation to the vagus nerve located on the outer ear, aiming to improve cognitive function.
Sham DeviceDevice
Participants in this arm will use a sham device. This device is identical in appearance to the active Cerogrin device but delivers no electrical stimulation or therapeutic effect. The sham device serves as a control to compare outcomes with the active treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Cerogrin Group | Experimental | Participants in this group will receive transcutaneous auricular vagus nerve stimulation using the Cerogrin device. Receives: Device: Cerogrin |
| Sham Group | Sham comparator | Participants in this group will use a sham device identical in appearance to the Cerogrin device but delivering no stimulation. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
The CDR-SB is a scale that evaluates a patient's cognitive function and ability to live independently. The scores range from 0 to 18, with higher scores indicating more severe cognitive impairment.
Measured: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
Change from Baseline in Korean Montreal Cognitive Assessment (K-MoCA) Score
he K-MoCA is a cognitive screening tool used to detect mild cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
Change from Baseline in Korean Mini-Mental State Examination-2 (K-MMSE-II) Score
The K-MMSE-II is a cognitive screening test used to assess a person's cognitive function, with scores ranging from 0 to 30.
Measured: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) Score
The ADAS-cog 13 is a scale used to assess the severity of cognitive symptoms in Alzheimer's disease. Higher scores indicate greater cognitive impairment.
Measured: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
Change from Baseline in Controlled Oral Word Association Test (COWAT) Score
This test measures a person's verbal fluency and executive function.
Measured: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
Change from Baseline in Stroop Test Score
The Stroop test measures a person's cognitive flexibility and executive function.
Measured: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
Change from Baseline in Trail Making Test (TMT) Score
The TMT is a neuro-psychological test of visual attention and task switching.
Measured: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
Secondary outcomes (3)
Change from Baseline in DTI-ALPS Score on Magnetic Resonance Imaging (MRI)
This score evaluates the brain's perivascular space, which is related to cerebral small vessel disease.
Measured: Baseline to Week 4 (End of Intervention Period)
Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI)
This method measures brain activity by detecting changes in blood flow.
Measured: Baseline to Week 4 (End of Intervention Period)
Change from Baseline in Electroencephalogram (EEG) Brain Wave Analysis
Descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) for changes in EEG power and relative EEG power by brainwave frequency band will be presented for each group. Statistical significance of the differences between groups will be tested using ANCOVA, with the indication (vascular dementia/vascular mild cognitive impairment) and baseline relative EEG power as covariates.
Measured: Baseline to Week 4 (End of Intervention Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start15 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DementiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurogrin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaeho Kim, M.D., Ph.D., Principal investigator, Hallym University Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149038
- Sponsor's protocol ID
- NG-VCI-01
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind Feasibility Trial Assessing the Initial Efficacy and Safety of Cerogrin, a Medical Device for Auricular Vagus Nerve Stimulation, in Improving Cognition in Patients With Vascular Dementia or Vascular Mild Cognitive Impairment: A Comparison With Sham Control
- ClinicalTrials.gov ID
- NCT07149038
- Acronym / sponsor ID
- NG-VCI-01
- Conditions
- Vascular Dementia, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Neurogrin Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Aug 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.
This clinical trial evaluates the preliminary effectiveness and safety of Cerogrin, a medical device developed by Neurogrin Inc. for auricular vagus nerve stimulation, in patients with vascular dementia or vascular mild cognitive impairment. Given the limited availability of effective pharmacological treatments for these conditions, the study aims to assess whether Cerogrin can enhance cognitive function through non-invasive neuromodulation.
Twenty-four participants will be randomized to receive either the active Cerogrin device or a sham (non-stimulating) device. Daily use will occur at home for 30 minutes over a four-week intervention period. The full study duration, including baseline assessments and follow-up, will span up to three months. During this period, cognitive function, neural activity, and safety outcomes will be systematically evaluated. This feasibility trial represents a critical step toward expanding therapeutic options for vascular cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerogrin Group | Experimental | Device: CerogrinParticipants in this group will receive transcutaneous auricular vagus nerve stimulation using the Cerogrin device. |
| Sham Group | Sham comparator | Device: Sham DeviceParticipants in this group will use a sham device identical in appearance to the Cerogrin device but delivering no stimulation. |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged 55 to 89 years.
- Diagnosed with vascular dementia or vascular mild cognitive impairment within 1 year before screening, with subcortical lesions confirmed on MRI.
- For both diagnoses:
- Severe white matter hyperintensity on MRI (Fazekas scale: deep white matter ≥ 2.5 cm or caps/bands ≥ 1.0 cm).
- Z-score < -1.0 SD in at least one cognitive domain (adjusted for education, age, and sex).
Key exclusion criteria (10 listed)
- Dementia other than vascular dementia (e.g., Alzheimer's disease, Lewy body dementia, frontotemporal dementia).
- Conditions causing cognitive decline (e.g., uncontrolled metabolic diseases, CNS infections, cerebrovascular disease, traumatic brain injury, Parkinson's disease).
- Severe psychiatric disorders (e.g., major depression, schizophrenia, substance abuse).
- Serious unstable physical conditions.
- MRI contraindications (e.g., claustrophobia, metal implants, contrast agent allergy).
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 |
|---|---|---|
| CerogrinParticipants in this arm will receive transcutaneous auricular vagus nerve stimulation using the Cerogrin device. This device non-invasively delivers electrical stimulation to the vagus nerve located on the outer ear, aiming to improve cognitive function. | Device | Cerogrin Group |
| Sham DeviceParticipants in this arm will use a sham device. This device is identical in appearance to the active Cerogrin device but delivers no electrical stimulation or therapeutic effect. The sham device serves as a control to compare outcomes with the active treatment group. | Device | Sham Group |
Primary outcome
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
The CDR-SB is a scale that evaluates a patient's cognitive function and ability to live independently. The scores range from 0 to 18, with higher scores indicating more severe cognitive impairment.
Change from Baseline in Korean Montreal Cognitive Assessment (K-MoCA) Score
Time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
he K-MoCA is a cognitive screening tool used to detect mild cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Change from Baseline in Korean Mini-Mental State Examination-2 (K-MMSE-II) Score
Time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
The K-MMSE-II is a cognitive screening test used to assess a person's cognitive function, with scores ranging from 0 to 30.
Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) Score
Time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
The ADAS-cog 13 is a scale used to assess the severity of cognitive symptoms in Alzheimer's disease. Higher scores indicate greater cognitive impairment.
Change from Baseline in Controlled Oral Word Association Test (COWAT) Score
Time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
This test measures a person's verbal fluency and executive function.
Change from Baseline in Stroop Test Score
Time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
The Stroop test measures a person's cognitive flexibility and executive function.
Change from Baseline in Trail Making Test (TMT) Score
Time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)
The TMT is a neuro-psychological test of visual attention and task switching.
3 secondary outcomes
Change from Baseline in DTI-ALPS Score on Magnetic Resonance Imaging (MRI)
Time frame: Baseline to Week 4 (End of Intervention Period)
Change from Baseline in Brain Function using Functional Magnetic Resonance Imaging (fMRI)
Time frame: Baseline to Week 4 (End of Intervention Period)
Change from Baseline in Electroencephalogram (EEG) Brain Wave Analysis
Time frame: Baseline to Week 4 (End of Intervention Period)
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 18 Sep 2026.
- 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. This study is not recruiting at the moment.
Jaeho Kim, M.D., Ph.D. principal investigator
Hallym University Dongtan Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerogrin in people with Vascular Dementia and Mild Cognitive Impairment, run by Neurogrin Inc. at 1 site in South Korea.
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 13 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score (time frame: Baseline to Week 4 (End of Intervention Period) and/or Week 8 (End of Follow-up)). The study lists 7 primary outcomes in all. 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 18 Sep 2026.