Gamma Light and Sound Therapy for Alzheimer's Disease
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications, such as amyloid reducing therapy, NMDA receptor antagonists like Memantine, and medications that lower the seizure threshold. If you are on psychiatric medications, you must be on a stable dose for at least three months before joining the trial.
What data supports the effectiveness of the Gamma Light and Sound Therapy treatment for Alzheimer's Disease?
Is Gamma Light and Sound Therapy safe for humans?
How is the GENUS device treatment different from other Alzheimer's treatments?
The GENUS device treatment is unique because it uses non-invasive light and sound therapy at 40 Hz to stimulate brain activity, which may help improve cognitive function and daily living activities in Alzheimer's patients. Unlike traditional drug treatments, this therapy aims to restore normal brain oscillations and has shown promise in both animal and early human studies without reported side effects.13589
What is the purpose of this trial?
Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. The investigator's lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. The investigators developed a light and sound device for humans that stimulates the brain at 40Hz that can be used safely at home. For the present study, 60 participants with mild Alzheimer's disease will be enrolled and will use this light and sound device at-home daily for 6-months. Investigators will measure changes in brain waves with EEG, blood biomarkers, the microbiome via fecal samples, functional and structural MRI scans, memory and cognitive testing, and questionnaires at 3 in-person visits throughout the study. After the 6-month time point, participants will have the option of continuing in the study for one additional year and completing an 18-month study visit. This study will provide critical insight into extended therapy involving non-invasive 40Hz sensory stimulation as a possible therapeutic strategy for mild to moderate Alzheimer's disease.
Research Team
Li Huei Tsai, PhD
Principal Investigator
Massachusetts Institute of Technology
Eligibility Criteria
This trial is for individuals aged 50-100 with mild Alzheimer's disease, having an MMSE score of 19-26. They must be able to give consent or have a representative do so and complete the first month at their primary residence. Excluded are those without healthcare, on certain Alzheimer's medications, unstable psychiatric treatments, seizure history within two years, significant suicide risk, behavioral issues affecting compliance, recent stroke or eye surgery candidates.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use a gamma light and sound device at-home daily for 6 months, with 3 in-person visits for assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment for one additional year with guaranteed 40Hz active treatment
Treatment Details
Interventions
- GENUS device
GENUS device is already approved in United States for the following indications:
- Alzheimer's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Institute of Technology
Lead Sponsor