Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People At Risk for Alzheimer's Disease
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT05776641
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Family Members
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - 90 Years
- Healthy Volunteers
- Accepted
Interventions
- GENUS — DEVICEParticipants will use the GENUS light and sound device at home for 60 minutes daily for 12 months
Study Details
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. Gamma waves are important for memory, and in patients with AD, there are fewer gamma waves in the brain. The Tsai 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. A light and sound device was developed for humans that stimulates the brain at 40Hz that can be used safely at home. The goal of this study is to see if using this device can prevent dementia in people who are at risk for developing Alzheimer's disease.
Key Dates
- Start date
- Jan 10, 2024
- Status verified
- Sep 2024
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: Active GENUS light and soundThe device is a light and sound device that delivers light stimulation using light-emitting diodes (LED) and sound stimulation through a speaker, with a centrally-mounted tablet that plays videos for entertainment. The device will be positioned on an easel such that the tablet is eye level with the participant while they are sitting 5 feet away. The active device delivers light and sound at 40Hz rate.
- Sham Comparator: Sham GENUS light and soundThe device is the same as the active device but it delivers light and sound at different frequencies.
Primary Outcome Measure
Changes in brain amyloid deposition over the study period, as measured by PiB PET. [ Time Frame: Baseline to 12 months ]
Central Contacts
- MJ Quay, MA617-807-0856
- Gabrielle de Weck, BS617-258-7723
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Diane Chan, MD PhD |
| Massachusetts Institute of Technology | Cambridge | Massachusetts | 02139 | - |
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