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New treatment option for Vascular Dementia
Official title Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT07149038
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 89
You may be able to join if
- 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).
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Hwaseong-si, Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hwaseong-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.