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VR headset aims to soothe Alzheimer's brain — but is it safe?

NCT ID NCT06234930

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a virtual reality headset that plays synchronized sounds and lights is safe and tolerable for people with early Alzheimer's and for healthy older adults. Twenty-seven participants wore the headset while researchers measured brain activity and asked about side effects. The goal was not to treat the disease, but to see if the approach is feasible and well-tolerated.

What this could mean

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

Active substance
VR headset delivering synchronized sound and light
What this could lead to
If it works, this could point toward a non-drug way to stimulate brain activity in Alzheimer's.
What could go wrong
This is a very early feasibility study with only 27 people. It only checks safety and brainwave changes, not whether it helps memory or thinking.

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

27 people

The number who actually took part.

Started

Jul 2024

Finished

Mar 2025

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

50 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Mild AD/ MCI due to AD Participants: * Age between 50 - 90 years old. * A clinical diagnosis of Mild Cognitive Impairment due to Alzheimer's disease (confirmed by PET scan or CSF biomarkers) or Mild Alzheimer's disease * MoCA score of 18-25. * Willingness to sign informed consent document (if deemed to not have the capacity to sign the informed consent, a legally authorized representative will be asked to provide surrogate consent). * Sufficient visual and hearing ability. * Formal education of 8 or more years. * Native English speakers or demonstrated fluency in English (participant; and LAR as needed) Inclusion Criteria Cognitively Healthy Participants: * Age between 50 - 90 years old. * A MoCA score above or equal to 26. * Willingness to sign informed consent document. * Sufficient visual and hearing ability. * Formal education of 8 or more years. * Native English speakers or demonstrated fluency in English (participant) Exclusion Criteria Mild AD/ MCI due to AD Participants: * Previous exposure to monoclonal antibody medication (e.g., Lecanemab, Aducanumab). * Active treatment with Memantine within the past 30 days. * Initiation of acetylcholinesterase inhibitors within the past 30 days. * A history of seizure or epilepsy including family history of seizure or epilepsy. * A history of stroke. * A diagnosis of migraine headache. * History of alcohol use disorder within the past 2 years (DSM-V criteria). * Current or past history of any neurological disorder other than dementia. * Use of hearing aid device(s). * Any known blood pathogens or disorders. * Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities. * Pregnancy (Verbal confirmation). * Geriatric Depression Scale (GDS) \>8 Exclusion Criteria Cognitively Healthy Participants: * Active treatment with Memantine within the past 30 days. * Initiation of treatment with acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine and galantamine) within the past 30 days. * A history of seizure or epilepsy including family history of seizure or epilepsy. * A history of stroke. * A diagnosis of migraine headache. * History of alcohol use disorder within the past 2 years (DSM-V criteria). * Use of hearing aid device(s). * Any known blood pathogens or disorders. * A diagnosis of Alzheimer's disease and related dementias. * Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities. * Pregnancy (Verbal confirmation) * Geriatric Depression Scale (GDS) \>8

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Lakeview Institute of Clinical Research LLC

    Leesburg, Florida, 34748, United States

  • The Sequoias Portola Valley

    Portola Valley, California, 18503, United States

More trials for these conditions

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