Status:
RECRUITING
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
Lead Sponsor:
Neurogrin Inc.
Conditions:
Vascular Dementia
Mild Cognitive Impairment
Eligibility:
All Genders
55-89 years
Phase:
NA
Brief 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 dement...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- 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.
- Exclusion Criteria
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07149038
Start Date
October 15 2025
End Date
December 30 2026
Last Update
November 18 2025
Active Locations (1)
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1
Dongtan Hallym University Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea, 18450