Actively Recruiting
Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation Using Light and Sound Devices at Home
Led by Massachusetts Institute of Technology · Updated on 2026-03-30
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Alzheimer's disease (AD) causes significant memory loss and involves harmful protein buildups (amyloid and tau) in the brain, along with changes in brain wave patterns called gamma waves. Researchers found that stimulating these gamma waves at 40Hz using light and sound helped reduce these proteins and improved memory in mouse models. This study is investigating whether a similar light and sound device can safely stimulate the brains of people with mild AD to potentially improve brain function. Participants will be randomly assigned to use a device at home for 60 minutes daily over six months. Half will receive active stimulation at 40Hz, while the other half will receive a sham (inactive) version. The study includes three in-person visits for assessments at baseline, three months, and six months. Participants may continue in an extension phase for at least one year, receiving the active treatment and yearly follow-up visits. Throughout the study, participants will undergo brain wave (EEG) tests, MRI scans, blood and fecal sample collections, cognitive and memory tests, and complete questionnaires. A wearable device will track sleep and activity. Researchers will monitor changes in brain function, molecular markers, microbiome, cognition, and safety. The study aims to understand if this non-invasive therapy can be a potential treatment strategy for mild to moderate Alzheimer's disease.
CONDITIONS
Brief Title
Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 65 and 100 years
- Diagnosed with mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19-26
- Willing to sign informed consent or have a legally authorized representative provide consent
- Able to complete the first month of at-home stimulation at their primary residence
- If planning to be away from home for more than one week during the trial, inclusion must be assessed by the research team
You will not qualify if you...
- Do not have healthcare coverage
- Currently taking amyloid reducing therapy
- Have more than 4 cerebral microbleeds or 1 macrobleed in the brain
- On psychiatric medications for less than three months (stable doses longer than three months allowed)
- Actively diagnosed with cancer and undergoing treatment
- Taking NMDA receptor antagonists (e.g., Memantine)
- Taking medications that lower seizure threshold (e.g., wellbutrin, ciprofloxacin, levofloxacin)
- History of seizure or epilepsy
- Clinically significant suicide risk or suicide attempt in the past year
- Behavioral problems that interfere with protocol compliance
- Untreated or unstable depression
- Active treatment with anti-epileptic agents
- Stroke within the past 24 months
- Eye surgery in the last 3 months or planned in next 6 months
- Diagnosed with migraine headache
- Have an active implantable medical device (e.g., ICD, DBS, pacemaker)
- Profound hearing or visual impairment
- Life expectancy less than 2 years
- Pregnant
- History of neurological disorders other than dementia or prior neurosurgery/head trauma with lasting impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
3 visits at baseline, 3 months, and 6 months (in-person)
Duration - 6 months
Participants use a light and sound device daily at home for 60 minutes to stimulate the brain at 40Hz or sham settings for 6 months.
3 visits at baseline, 3 months, and 6 months (in-person)
Duration - At least 1 year
Participants may continue to use the active 40Hz device daily at home and attend yearly visits to monitor progress.
Yearly visits (in-person)
Trial Site Locations
Total: 1 location
1
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02142
Actively Recruiting
Research Team
G
gamma wave
A
Ana Trisini Lipsanopoulos, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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