Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation

Status: Recruiting
Location: See location...
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. The investigator's 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. The investigators developed a light and sound device for humans that stimulates the brain at 40Hz that can be used safely at home. For the present study, 60 participants with mild Alzheimer's disease will be enrolled and will use this light and sound device at-home daily for 6-months. Investigators will measure changes in brain waves with EEG, blood biomarkers, the microbiome via fecal samples, functional and structural MRI scans, memory and cognitive testing, and questionnaires at 3 in-person visits throughout the study. After the 6-month time point, participants will have the option of continuing in the study for one additional year and completing an 18-month study visit. This study will provide critical insight into extended therapy involving non-invasive 40Hz sensory stimulation as a possible therapeutic strategy for mild to moderate Alzheimer's disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 100
Healthy Volunteers: t
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⁃ Subjects may be enrolled into the study if they meet all of the following criteria:

• Subject is between the ages of 65 - 100.

• Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19-26.

• Subject is willing to sign informed consent document.

• If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.

• Able to complete the 1st month of at home stimulation at their primary residence. If subjects plan to spend more than 1 week away from their primary residence during the trial, their inclusion must be assessed by the research team.

Locations
United States
Massachusetts
Massachusetts Institute of Technology
RECRUITING
Cambridge
Contact Information
Primary
MJ Quay, MS
mcolburn@mit.edu
617-258-7723
Backup
Remi Philips, BA
remip@mit.edu
617-258-7723
Time Frame
Start Date: 2022-12-14
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Alzheimer's Active Arm
Exposure to active sensory stimulation (40Hz) for 60 minutes daily for the length of the trial (6 months).
Sham_comparator: Alzheimer's Control Arm
Exposure to control stimulation (sham) for 60 minutes daily for the length of the trial (6 months).
Sponsors
Leads: Massachusetts Institute of Technology

This content was sourced from clinicaltrials.gov

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