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Flashing lights and tones could stop Alzheimer's before it starts

NCT ID NCT05776641

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a device that flashes light and plays sound at 40Hz can prevent Alzheimer's disease in people at risk. 200 adults aged 55-90 with a family history of Alzheimer's will use the device at home for 60 minutes daily over 12 months. Researchers will measure changes in brain amyloid and tau proteins using PET scans to see if the stimulation slows or stops disease progression.

What this could mean

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

Active substance
GENUS light and sound device (40Hz gamma entrainment)
What this could lead to
If it works, this could point toward a simple, non-invasive way to prevent Alzheimer's disease in people with a family history.
What could go wrong
This is an early-stage study with no phase designation, so results are uncertain. The device may not reduce amyloid or tau buildup in humans as it did in mice, and daily use for a year may be challenging.

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 200 people

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

Started

Jun 2024

Expected to finish

May 2027

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

55 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: 1. Between 55 - 90 years of age, inclusive. 2. Immediate family history of Alzheimer's disease. 3. Mini-Mental State Exam (MMSE) score of 27 or greater at baseline or expected score range for cognitively normal adjusted for education level. 4. Clinical Dementia Rating Global Score of 0 at baseline. 5. Delayed Recall score on the Logical Memory IIa subtest of 8 to 15 at baseline or expected score range for cognitively normal adjusted for education level. 6. Low serum amyloid levels at baseline. 7. Elevated fibrillar amyloid using 11C PiB PET at baseline between 20 - 70 CL. 8. Willing and able to undergo MRI brain and PET brain scans. 9. Adequate visual and auditory acuity to allow for neuropsychological testing. 10. Able to comply with neuropsychological testing and other study procedures in opinion of site PI. 11. Willing and able to complete baseline assessments, and willing to participate in 13-month study protocol. 12. Willing to provide blood samples at specified timepoints. Willing to consider contributing CSF samples at specified timepoints, if asked. Exclusion Criteria: 1. MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body. 2. High myopia \< -7 diopters, or untreated cataracts that affect vision. 3. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol. 4. For subjects agreeing to undergo lumbar punctures, history of bleeding disorders or laboratory results indicating low platelet levels are exclusionary for the procedure. 5. Concomitant medications: 1. Treatment with NMDA antagonists. 2. For subjects undergoing lumbar puncture, current use of warfarin or similar anti-coagulants is exclusionary for the procedure. 6. Clinical conditions: 1. History of seizure or medical diagnosis of epilepsy. 2. Female subjects who are pregnant or currently breastfeeding. 3. History of severe allergic or anaphylactic reactions. 4. Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed. 5. Neurodegenerative disorder associated with cognitive impairment. 6. Renal disease. 7. MR imaging findings such as stroke, tumor, leukoencephalopathy that could preclude meaningful analyses of clinical and imaging data in the opinion of the site PI, such as: 1. Severe leukoencephalopathy seen on MRI. 2. Relevant structural abnormality (i.e., normal pressure or obstructive hydrocephalus, hypoxic ischemic lesions, hemorrhages, tumors, malformations). 3. Cerebral amyloid angiopathy, evidenced by T2\* or other susceptibility weighted-MRI. 8. Laboratory findings, if known (study does not perform testing) suggestive of systemic illness such as renal disease. 9. Site investigator's discretion, if s/he feels the subject cannot complete sufficient key study procedures. Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director.

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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.

How to take part

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

  1. The places running it

    2 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

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Massachusetts Institute of Technology

    RECRUITING

    Cambridge, Massachusetts, 02139, United States

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