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Could a light helmet slow Alzheimer's? new study begins

NCT ID NCT06836180

Symptom relief Sponsor: Xuanwu Hospital, Beijing 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase study will test whether shining near-infrared light on the head each day can help people with mild to moderate Alzheimer's disease. Forty participants will receive 30-minute light sessions six times a week for 96 weeks. Researchers will measure changes in thinking and memory, as well as safety.

What this could mean

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

Active substance
near-infrared light therapy (device)
What this could lead to
If it works, this could point toward a non-drug way to ease cognitive decline in Alzheimer's disease.
What could go wrong
This is a very early, small study (40 people) with no control group, so results may not be reliable. The treatment requires daily sessions for nearly two years, which may be hard to stick with.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 40 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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: * 50 - 90 years old, no gender limitation; * Meeting the National Institute on Aging and Alzheimer's Association (2011 NIA-AA) is likely the core clinical diagnostic criteria for Alzheimer's disease; * The MMSE score is ≥ 12 and ≤ 26; * The subjects should have primary school education or above and be able to complete the cognitive ability measurement and other tests stipulated in the protocol; * If taking cognitive-improving medications, the dose must be stable for at least 12 weeks prior to enrollment (stable for at least 4 weeks with psychotropic medications); * Participants themselves or their guardians voluntarily participate and sign the informed consent. Exclusion Criteria: * Any cognitive impairment or dementia not caused by Alzheimer's disease, or co-existing with a serious mental illness (schizophrenia, bipolar disorder, major depression, etc.); * Currently taking anticoagulant drugs; * A history of seizures or hemorrhagic stroke within 12 months; * Allergic to sunlight or visible light or high sensitivity to head and neck skin; * Severe head trauma or implants (bone nails, bone plates, excision, etc.); * Malignant tumors; * Any other medical condition that is not stabilized and adequately controlled (such as serious heart, respiratory, gastrointestinal, or kidney disease), or that the investigator believes may affect patient safety or interfere with the evaluation of the test; * Persons addicted to alcohol or drugs; * Women who are pregnant, nursing or planning a pregnancy; * Participated in other clinical studies within 1 month before participating in this trial; * Other conditions deemed unsuitable for clinical trial participation by the investigator.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

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

Alzheimer disease

How to take part

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

  1. The places running it

    1 site. 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

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053, China

More trials for these conditions

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