Light and Sound Stimulation for Alzheimer's Disease
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Diane Chan, MD, PhD
Principal Investigator
Massachusetts Institute of Technology
Li-Huei Tsai, 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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations 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
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
What Are the Treatments Tested in This Trial?
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