Light and Sound Stimulation for Alzheimer's Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Institute of Technology

Must not be taking: NMDA antagonists, Seizure threshold reducers, Anti-epileptics, Psychiatric agents

Disqualifiers: Seizure, Stroke, Migraine, Suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6-9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily light and sound therapy using the GENUS device can help individuals with mild Alzheimer's disease. The goal is to determine the safety of this new approach and its potential to improve symptoms. Participants will receive either active stimulation or a controlled (inactive) version for comparison. Ideal candidates have mild Alzheimer's, live within two hours of Boston, and can complete one month of home-based therapy without long absences.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research in Alzheimer's treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, you cannot be on NMDA receptor antagonists, medications that lower seizure threshold, anti-epileptic agents, or psychiatric medications like antidepressants or antipsychotics.

What prior data suggests that the GENUS device is safe for people with mild Alzheimer's Disease?

Research shows that the GENUS device, which uses light and sound, is generally safe for people with mild Alzheimer's disease. Small studies have tested a 40Hz light and sound treatment similar to what this device offers. These studies confirm that the treatment is safe and has not caused serious side effects. Participants have tolerated the treatment well.

In one study, patients used this type of stimulation daily and did not report major problems. The treatment involved a routine of daily light and sound exposure, which participants found manageable. Although researchers are still examining the long-term effects, current information suggests it is safe. As with any treatment, staying in touch with healthcare providers for updates and personal advice is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GENUS device because it explores a novel approach for Alzheimer's disease through light and sound stimulation. Unlike current treatments, which often focus on managing symptoms with medications like cholinesterase inhibitors or NMDA receptor antagonists, the GENUS device aims to directly influence brain activity. By using specific frequencies of light and sound, it targets brain waves to potentially improve cognitive function. This innovative method could offer a non-invasive, drug-free option, which is a significant shift from traditional pharmacological treatments.

What evidence suggests that the GENUS device is effective for Alzheimer's Disease?

Research has shown that using daily light and sound at a specific frequency, known as 40Hz or gamma frequency, might help slow memory problems in people with Alzheimer's disease. One study found that this type of stimulation can improve brain health by enhancing brain waves important for memory and thinking. Another long-term study suggested that this method might help people with late-onset Alzheimer's experience slower memory loss. In this trial, participants will join different arms: one group will receive daily exposure to active 40Hz light and sound stimulation using the GENUS device, while another group will receive control stimulation. Although the results are promising, this treatment might not work as well for early-onset Alzheimer's due to differences in the disease. Overall, evidence suggests that this approach could be a hopeful option for managing Alzheimer's symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Emery Brown, MD, PhD

Principal Investigator

Massachusetts Institute of Technology

Li-Huei Tsai, PhD

Principal Investigator

Massachusetts Institute of Technology

Diane Chan, MD, PhD

Principal Investigator

Massachusetts Institute of Technology

Edward S Boyden, PhD

Principal Investigator

Massachusetts Institute of Technology

Are You a Good Fit for This Trial?

This trial is for people aged 50-100 with mild Alzheimer's Disease, scoring 19-26 on the MMSE. They must live within two hours of Boston and be able to do a month of home stimulation. Excluded are those at suicide risk, recent stroke survivors, life expectancy under 24 months, without healthcare, taking certain medications like NMDA antagonists or seizure threshold lowering drugs, with active implants (e.g., pacemakers), pregnant women, those on anti-epileptic or psychiatric meds, and individuals with severe hearing/vision loss or behavioral issues.

Inclusion Criteria

Subjects whose primary residence is within 2 hours of Boston

If I can't consent, a legal representative will do it for me.

My Alzheimer's is mild, with an MMSE score between 19 and 26.

Exclusion Criteria

I am currently taking medication for epilepsy.

I have not had a seizure or been diagnosed with epilepsy in the last 2 years.

I have had a stroke in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the GENUS device at home for 1 hour per day for 6 or 9 months, with evaluations at baseline, Month 1, Month 3, and Month 6 or 9

6-9 months

4 visits (in-person) at baseline, Month 1, Month 3, and Month 6 or 9

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at Month 7 or 10 and Month 12 or 18

1 month

2 visits (in-person) at Month 7 or 10 and Month 12 or 18

Open-label extension (optional)

Participants may opt into continuation of treatment for an additional 6 or 9 months with active settings

6-9 months

Long-term extension

Participants who complete the study protocol are offered a long-term extension for a total of 36 months with yearly follow-up evaluations

36 months

What Are the Treatments Tested in This Trial?

Interventions

• GENUS device

Trial Overview The GENUS device is being tested for its safety and effectiveness in improving brain functions in mild Alzheimer's patients through daily light and sound stimulation. Participants will use either the active settings of the device or sham (inactive) settings as a comparison over an extended period due to COVID-19 adjustments.

How Is the Trial Designed?

Group I: Daily exposure to active stimulation Experimental Treatment 1 Intervention

Subjects in this arm will receive daily exposure to active stimulation

Group II: Daily exposure to control stimulation Placebo Group 1 Intervention

Subjects in this arm will receive daily exposure to control stimulation

GENUS device is already approved in United States for the following indications:

Approved in United States as 40Hz Light and Sound Therapy for:

• Alzheimer's disease

Who Is Running the Clinical Trial?

Massachusetts Institute of Technology

Lead Sponsor

Trials

104

Recruited

12,810,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05655195

Chronic Treatment of Alzheimer's Disease by Gamma Light ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12552893/

Gamma sensory stimulation in mild Alzheimer's dementia We evaluated the long‐term effects of daily 40 Hz (gamma frequency) audiovisual stimulation on cognition and biomarkers in five patients ...

3. neurosciencenews.com neurosciencenews.com/daily-light-sound-memory-alzheimers-29865/

Daily Light and Sound Therapy May Slow Alzheimer's ... A long-term study found that daily 40Hz light and sound stimulation may help slow cognitive decline in people with late-onset Alzheimer's ...

4. news.mit.edu news.mit.edu/2025/evidence-40hz-gamma-stimulation-promotes-brain-health-expanding-0314

Evidence that 40Hz gamma stimulation promotes brain ... A decade of studies provide a growing evidence base that increasing the power of the brain's gamma rhythms could help fight Alzheimer's, and perhaps other ...

5. picower.mit.edu picower.mit.edu/news/small-study-suggests-40hz-sensory-stimulation-may-benefit-some-alzheimers-patients-years

Small study suggests 40Hz sensory stimulation may benefit ... “GENUS may be less effective in early onset Alzheimer's disease patients, potentially owing to broad pathological differences from late-onset ...

6. picower.mit.edu picower.mit.edu/news/small-studies-40hz-sensory-stimulation-confirm-safety-suggest-alzheimers-benefits

Small studies of 40Hz sensory stimulation confirm safety ... MIT researchers report early stage clinical study results of tests with non-invasive 40Hz light and sound treatment.

7. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/genusprevention

GENUS Study: Can we prevent Alzheimer's disease using ... This study will look at how our device, GENUS (Gamma ENtrainment Using Sensory stimuli), can potentially prevent Alzheimer's dementia.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11952037/

40 Hz multisensory stimulation therapy for cognitive impairment This study explores the impact of a 40 Hz multisensory stimulation treatment on brain function, behavior, and disease progression in animal models