NCT04042922 · ACTIVE NOT RECRUITING
High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease
This trial tests a device that delivers flickering light and rhythmic sound at 40 Hz to stimulate brain activity in people with mild Alzheimer's disease. Researchers want to know whether the device is safe and practical to use, and they are measuring brain waves with EEG to understand how the brain responds. This is a Phase NA feasibility study — it is exploratory and early, not a test of whether the device treats or prevents Alzheimer's.
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.
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 1 year.
- 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 2 years.
- 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 2024-10-01