Flashing lights and tones could stop Alzheimer's before it starts
NCT ID NCT05776641
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
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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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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55 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Massachusetts Institute of Technology
RECRUITINGCambridge, Massachusetts, 02139, United States
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