RecruitingNot ApplicableNCT05655195

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

Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation


Sponsor

Massachusetts Institute of Technology

Enrollment

60 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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 at least one year and completing yearly study visits. 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.


Eligibility

Min Age: 65 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests a non-invasive home therapy that uses flickering light and sound at a specific frequency (gamma waves, 40 Hz) to try to slow or improve the symptoms of mild Alzheimer's disease. Participants use a special device at home for several months. **You may be eligible if...** - You are between 65 and 100 years old - You have been diagnosed with mild Alzheimer's disease - Your score on a standard memory/thinking test (MMSE) is between 19 and 26 - You are willing to use the device at your home and attend follow-up visits - If you cannot consent yourself, a legal representative can consent on your behalf **You may NOT be eligible if...** - You do not have mild Alzheimer's disease - Your memory test score falls outside the required range - You are unable to complete the required home-based sessions - You have other conditions that would make participation unsafe (determined by the research team) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGENUS device (Active Settings)

Participants in the active, experimental group will use the GENUS devices configured to active (40Hz) setting for 60 minutes daily for 6 months.

DEVICEGENUS device (sham settings)

Participants in the control group will use the GENUS devices configured to the sham settings for 60 minutes daily for 6 months.


Locations(1)

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

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NCT05655195


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