Prevention of Alzheimer's Disease Using Gamma Entrainment A Study of GENUS Light and Sound Stimulation to Prevent Dementia in People at Risk for Alzheimer's

What this Trial Is About

Alzheimer's disease (AD) causes significant memory loss and buildup of harmful proteins called amyloid and tau in the brain. This condition also affects brain waves called gamma waves, which are important for memory. Researchers found that increasing gamma waves at 40Hz using light and sound helped reduce these harmful proteins and improved memory in mouse models. The study aims to test if a similar light and sound device can prevent dementia in people at risk for Alzheimer's disease, particularly those aged 55 and older with a family history of AD and normal memory. Participants who qualify will use the GENUS device at home, which delivers light and sound stimulation at 40Hz for 60 minutes daily over 12 months. The study will enroll 200 participants, with 50 who have amyloid deposits in the brain continuing in the study. Neither participants nor researchers will know who receives the active or sham stimulation. Participants will visit Massachusetts General Hospital 4-6 times during the study for tests including PET scans, MRI, EEG, blood draws, memory assessments, and questionnaires. Optionally, some may provide cerebral spinal fluid samples. Throughout the study, participants will wear a watch to track sleep and activity. During the visits, researchers will measure changes in brain amyloid levels using PET scans and monitor memory and brain activity. Blood tests and imaging will track progress and safety. The entire participation lasts about 13 months, including baseline assessments and follow-up visits at 6 and 12 months. The study evaluates whether regular stimulation at 40Hz can reduce Alzheimer's disease pathology and help prevent dementia in at-risk individuals.

Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People At Risk for Alzheimer's Disease