Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment

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.