Prevention of Alzheimer's Disease Using Gamma Entrainment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: t
View:

• Between 55 - 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 score range for cognitively normal adjusted for education level.

• Clinical Dementia Rating Global Score of 0 at baseline.

• Delayed Recall score on the Logical Memory IIa subtest of 8 to 15 at baseline or expected score range for cognitively normal adjusted for education level.

• Low serum amyloid levels at baseline.

• Elevated fibrillar amyloid using 11C PiB PET at baseline between 20 - 70 CL.

• Willing and able to undergo MRI brain and PET brain scans.

• Adequate visual and auditory acuity to allow for neuropsychological testing.

⁃ Able to comply with neuropsychological testing and other study procedures in opinion of site PI.

⁃ Willing and able to complete baseline assessments, and willing to participate in 13-month study protocol.

⁃ Willing to provide blood samples at specified timepoints. Willing to consider contributing CSF samples at specified timepoints, if asked.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Massachusetts Institute of Technology
RECRUITING
Cambridge
Contact Information
Primary
MJ Quay, MA
mquay@mgb.org
617-807-0856
Backup
Gabrielle de Weck, BS
gdeweck@mit.edu
617-258-7723
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2026-05
Participants
Target number of participants: 200
Treatments
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.
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Massachusetts Institute of Technology

This content was sourced from clinicaltrials.gov