Actively Recruiting
Prevention of Alzheimer's Disease Using Gamma Entrainment with Light and Sound Stimulation in At-Risk Adults
Led by Massachusetts General Hospital · Updated on 2025-01-10
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
M
Massachusetts Institute of Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Alzheimer's disease (AD) is marked by memory loss, harmful protein build-up in the brain, and changes in brain wave patterns, specifically gamma waves important for memory. Researchers found that increasing these gamma waves in mouse models reduced these proteins and improved memory. This study aims to see if a light and sound device that stimulates the brain at 40Hz can prevent dementia in people at risk for Alzheimer's disease who have normal memory but a family history of AD. Participants aged 55 to 90 with normal memory and a close family history of Alzheimer's will be randomly assigned to use either an active device delivering light and sound stimulation at 40Hz or a sham device with different frequencies. They will use the device at home for 60 minutes daily over 12 months. The study includes 4-6 visits to a hospital for scans, blood tests, memory assessments, and questionnaires. Some participants may also provide cerebral spinal fluid samples. A wearable device will track sleep and activity throughout the study. Participants will undergo PET and MRI brain scans, EEG, blood tests, and memory tests at the start, mid-point, and end of the study to monitor brain changes and disease markers. Researchers will measure changes in brain amyloid and tau deposits, brain structure, electrical activity, connectivity, blood biomarkers, and participant adherence to device use. The study spans 13 months, including assessments and device use, with safety and progress monitored regularly.
CONDITIONS
Brief Title
Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People At Risk for Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 55 and 90 years of age, inclusive
- Immediate family history of Alzheimer's disease
- Mini-Mental State Exam (MMSE) score of 27 or greater at baseline or expected range for cognitively normal adjusted for education
- Clinical Dementia Rating Global Score of 0 at baseline
- Delayed Recall score on Logical Memory IIa subtest between 8 and 15 at baseline or expected range for cognitively normal adjusted for education
- Low serum amyloid levels at baseline
- Elevated fibrillar amyloid on 11C PiB PET scan between 20 and 70 CL at baseline
- Willing and able to undergo MRI and PET brain scans
- Adequate vision and hearing for neuropsychological testing
- Able to comply with testing and study procedures per site investigator
- Willing to complete baseline assessments and participate in 13-month protocol
- Willing to provide blood samples and consider providing cerebrospinal fluid samples if asked
You will not qualify if you...
- MRI contraindications such as pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects
- High myopia less than -7 diopters or untreated cataracts affecting vision
- Significant systemic illness or unstable medical condition interfering with study compliance
- History of bleeding disorders or low platelet levels if undergoing lumbar puncture
- Use of NMDA antagonists or, if undergoing lumbar puncture, current use of warfarin or similar anti-coagulants
- History of seizures or epilepsy diagnosis
- Pregnancy or breastfeeding in female participants
- History of severe allergic or anaphylactic reactions
- Longstanding alcohol or substance abuse with continuous abuse leading to symptoms
- Neurodegenerative disorders causing cognitive impairment
- Renal disease
- MRI findings such as severe leukoencephalopathy, structural abnormalities, or cerebral amyloid angiopathy that may affect analyses
- Laboratory findings suggesting systemic illness such as renal disease
- Investigator discretion if participant cannot complete key study procedures, with case-by-case exceptions possible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
4 to 6 visits (in-person) including PET scans, MRI, EEG, blood tests, and memory assessments
Duration - 12 months
Participants use the GENUS light and sound device at home for 60 minutes daily for 12 months to evaluate the effect on Alzheimer's disease pathology.
Participants wear a watch continuously to monitor sleep and activity throughout the study
Duration - Up to 12 months after starting device use
Participants return for follow-up visits to monitor brain amyloid deposition, tau deposition, brain structure, electrical activity, and other health markers after device usage.
3 visits (in-person) including baseline, 6 months, and 12 months assessments with PET scans, MRI, EEG, blood tests, and memory tests
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139
Actively Recruiting
Research Team
M
MJ Quay, MA
G
Gabrielle de Weck, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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