NCT07149038 · RECRUITING
Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
This trial tests Cerogrin, a wearable ear device that delivers mild electrical stimulation to the vagus nerve, in people with vascular dementia or vascular mild cognitive impairment. Researchers want to know whether 30 minutes of daily home use over four weeks improves cognition and is safe. This is a Phase NA feasibility trial — meaning it is a small early-stage study designed to see whether the approach is practical and shows initial promise, not to prove it works.
Eligibility criteria
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-18