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

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • GENUS — DEVICE
    Participants 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 sound
    The 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 sound
    The 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

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
MJ Quay, MA
617-807-0856
Andrew Becker, BS
617-258-7723
Diane Chan, MD PhD
Massachusetts Institute of TechnologyCambridgeMassachusetts02139-

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