NCT04055376 · ACTIVE NOT RECRUITING
Daily Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease
This trial is testing whether daily exposure to flickering light and pulsed sound at a specific frequency (40 Hz, known as gamma stimulation) can improve brain function in people who already have mild Alzheimer's disease. Participants use a device at home and are compared to a group using a sham version that delivers no real stimulation. This is a Phase NA designation, meaning it is a device feasibility and safety study rather than a standard drug efficacy trial.
You may qualify if
- Subject is between the ages of 50 - 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.
- Subjects whose primary residence is within 2 hours of Boston
- 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.
You're excluded if
- Subjects who do not have healthcare.
- 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 within the past 24 months.
- Subjects with clinically significant suicide risk and/or suicide attempt in the past 12 months.
- Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
- Active treatment with one or more anti-epileptic agent.
- Subjects who have had a stroke within the past 24 months.
- Subjects diagnosed with migraine headache.
- Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
- 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 24 months.
- Subjects who are pregnant.
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 2026-05-26