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