Actively Recruiting
Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People At Risk for Alzheimer's Disease
Led by Massachusetts General Hospital · Updated on 2025-01-10
200
Participants Needed
2
Research Sites
120 weeks
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 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.
CONDITIONS
Official 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 score of 27 or higher or expected normal range adjusted for education
- Clinical Dementia Rating Global Score of 0 at baseline
- Delayed Recall score on Logical Memory IIa of 8 to 15 or expected normal range adjusted for education
- Low serum amyloid levels at baseline
- Elevated fibrillar amyloid on 11C PiB PET scan between 20 and 70 CL
- Willing and able to undergo MRI and PET brain scans
- Adequate vision and hearing to complete neuropsychological testing
- Able to comply with neuropsychological tests and study procedures
- Willing and able to complete baseline assessments and participate in the 13-month study
- Willing to provide blood samples and consider providing cerebrospinal fluid samples if asked
You will not qualify if you...
- MRI contraindications like pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the body or eyes
- High myopia less than -7 diopters or untreated cataracts affecting vision
- Significant systemic illness or unstable medical condition affecting study compliance
- History of bleeding disorders or low platelet levels if agreeing to lumbar puncture
- Current treatment with NMDA antagonists
- Use of warfarin or similar anti-coagulants if undergoing lumbar puncture
- History of seizures or epilepsy
- Pregnant or breastfeeding females
- History of severe allergic or anaphylactic reactions
- Long history (over 10 years) of alcohol or substance abuse up to symptom development
- Neurodegenerative disorders causing cognitive impairment
- Kidney disease
- MRI findings such as severe leukoencephalopathy, structural brain abnormalities, or cerebral amyloid angiopathy that affect data analysis
- Laboratory findings suggestive of systemic illness like kidney disease
- Investigator's judgment that participant cannot complete key study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
G
Gabrielle de Weck, BS
CONTACT
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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