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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

In this trial, the safety and effect of daily exposure to light and sound stimulation on people with mild Alzheimer's Disease (AD) will be studied. COVID-19 Amendment: Due to the ongoing suspension of all in-person humans subject research across MIT in response to the COVID-19 pandemic, all enrolled participants who have not completed their 6-month visit will have their visit postponed to 9 months with a follow up at 18 months. Subjects who have completed their 6-month visit will still be instructed to continue and return at Month 12 for an evaluation. OPTIONAL: If the subject would like to come in for an evaluation between Month 9 and 18, we will invite participants to come on Month 12 to complete cognitive testing and EEG.

Research Team

Li-Huei Tsai, PhD

Principal Investigator

Massachusetts Institute of Technology

Diane Chan, MD, PhD

Principal Investigator

Massachusetts Institute of Technology

Emery Brown, MD, PhD

Principal Investigator

Massachusetts Institute of Technology

Edward S Boyden, PhD

Principal Investigator

Massachusetts Institute of Technology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+