NCT05655195 · RECRUITING

Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy

This trial tests a home-use light and sound device that pulses at 40 Hz — a specific brain-wave frequency — to see whether daily use over six months changes brain activity, memory, and biological markers in people with mild Alzheimer's disease. Half the participants get the active device; half get a sham version. It is a Phase N/A trial, meaning it is an exploratory study measuring effects rather than a late-stage efficacy trial. Sixty participants are enrolled.

Eligibility criteria

Inclusion Criteria:
Subjects may be enrolled into the study if they meet all of the following criteria:
* Subject is between the ages of 65 - 100.
* Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19-26.
* Subject is willing to sign informed consent document.
* If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.
* Able to complete the 1st month of at home stimulation at their primary residence. If subjects plan to spend more than 1 week away from their primary residence during the trial, their inclusion must be assessed by the research team.
Exclusion Criteria:
Subjects who meet any of the following conditions will not be enrolled in the study:
* Subjects who do not have healthcare.
* Subjects who are currently taking amyloid reducing therapy.
* Subjects who have > 4 cerebral microbleeds or 1 macrobleed in their brain
* Active treatment on a dosage of one or more psychiatric agents (e.g. antidepressants, antipsychotics, etc) for LESS THAN three months (a stable dose for greater than or equal to three months is ok).
* Subjects who are actively diagnosed with cancer and undergoing cancer-related treatments
* Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
* Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
* Subjects with history of seizure or epilepsy
* Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
* Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
* Subjects with untreated or unstable depression
* Active treatment with one or more anti-epileptic agent.
* Subjects who have had a stroke within the past 24 months.
* Subjects who have had eye surgery in the last 3 months or are scheduled to have eye surgery in the next 6 months (during the study)
* Subjects diagnosed with migraine headache.
* Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
* Subjects who have profound hearing or visual impairment.
* Subjects who have a life expectancy of less than 2 years.
* Subjects who are pregnant.
* Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-03-30

View full record on ClinicalTrials.gov

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