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Could a simple ear device help fight dementia?

NCT ID NCT07149038

Symptom relief Sponsor: Neurogrin Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests a small device called Cerogrin that gently stimulates a nerve in the ear, aiming to improve thinking and memory in people with vascular dementia or mild cognitive impairment. Twenty-four participants will use the device at home for 30 minutes daily over four weeks. The trial compares the active device to a sham (fake) device to see if it is safe and shows early signs of helping cognition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cerogrin device (auricular vagus nerve stimulation)
What this could lead to
If it works, this could offer a new, non-drug option to help slow cognitive decline in people with vascular dementia or mild cognitive impairment.
What could go wrong
This is a very small, early feasibility trial with only 24 participants. The results may not be strong enough to confirm effectiveness, and the device may not work better than a sham.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction vascular dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild cognitive impairment Vascular dementia

Contacts and locations

Locations

  • Dongtan Hallym University Sacred Heart Hospital

    Hwaseong-si, Gyeonggi-do, 18450, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.