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New device aims to sharpen memory in early Alzheimer's patients

NCT ID NCT07239310

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study tests a device called Neuclare that is placed on the head to see if it can temporarily improve planning and problem-solving skills in people with mild cognitive impairment or very early Alzheimer's disease. About 138 adults aged 55 to 90 who are already on memory medications will use the device three times a week for four weeks. Half will get the real device and half a fake one, and neither they nor the researchers will know which group they are in. The goal is to find a safe way to give a short-term boost to thinking abilities.

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 138 people

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

Started

Nov 2025

Expected to finish

Jan 2027

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 90 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: 1. Adults aged 55 to 90 years. 2. Diagnosed with mild cognitive impairment (MCI) or early Alzheimer's disease according to the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria. 3. mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18. 4. On stable cognitive therapy medications for at least 1 month. 5. Voluntary participation with signed informed consent. Exclusion Criteria: 1. Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.). 2. Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic/renal impairment, or those on long-term medications that may cause cognitive impairment (e.g., anticholinergic drugs). 3. Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline. 4. Patients with psychiatric disorders outside of the inclusion criteria. 5. Patients with a history of severe diseases such as cancer or tuberculosis. 6. Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system. 7. Patients with contact dermatitis or other skin hypersensitivity conditions. 8. Patients with fever ≥ 40°C as measured by tympanic temperature. 9. Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs. 10. Patients unable to undergo MRI. 11. Pregnant patients. 12. Patients with clinical brain calcification observed on computed tomography (CT) scans. 13. Patients with known allergies to contrast agents such as Definity or Gadovist. 14. Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ewha Womans University Mokdong Hospital

    RECRUITING

    Seoul, 07985, South Korea

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Seoul, 07804, South Korea

  • Hallym University Dongtan Sacred Heart Hospital

    RECRUITING

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

  • Inha University Hospital

    RECRUITING

    Incheon, Gyeonggi-do, 22332, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Soonchunhyang University Cheonan Hospital

    RECRUITING

    Cheonan, Chungcheongnam-do, 31151, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    RECRUITING

    Suwon, Gyeonggi-do, 16247, South Korea

More trials for these conditions

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