Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT05655195
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • GENUS device (Active Settings) — DEVICE
    Participants in the active, experimental group will use the GENUS devices configured to active (40Hz) setting for 60 minutes daily for 6 months.
  • GENUS device (sham settings) — DEVICE
    Participants in the control group will use the GENUS devices configured to the sham settings for 60 minutes daily for 6 months.

Study Details

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 at least one year and completing yearly study visits. 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.

Key Dates

Start date
Dec 14, 2022
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Feasibility of gamma frequency stimulation as assessed by a change of gamma frequency waves during EEG [ Time Frame: Immediately after completing the stimulation at baseline, month 3, and month 6 visits ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Institute of TechnologyCambridgeMassachusetts02142
Ana Trisini Lipsanopoulos, BS
[email protected]
617-258-7723

Find similar trials in Cambridge, MA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Massachusetts Institute of Technology· Cambridge, MA

Related Studies