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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 30, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 1, 2025 to Sep 1, 2026 Enrollment target: 50 to 60 · Site contact updated · Study description shortened, about 3 wordsv7 Show 3 more changesShow less
    • Enrollment target: 50 to 60
    • Site contact updated
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Site contact updatedv6
  3. Primary completion date: Sep 1, 2024 to Dec 1, 2025 Completion date: Sep 1, 2024 to Sep 1, 2026 · Eligibility criteria expanded, about 17 words · Study description revised · 1 morev5 Show 4 more changesShow less
    • Completion date: Sep 1, 2024 to Sep 1, 2026
    • Eligibility criteria expanded, about 17 words
    • Study description revised
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 16 wordsv4 See this version in full on ClinicalTrials.gov ↗
  5. Eligibility criteria expanded, about 47 wordsv3 See this version in full on ClinicalTrials.gov ↗
  6. Eligibility criteria expanded, about 39 words Study description expanded, about 91 wordsv2 Show 1 more changeShow less
    • Study description expanded, about 91 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05655195
Lead Sponsor Massachusetts Institute of Technology
Conditions Alzheimer Disease, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer's Disease (Incl Subtypes), Alzheimer's, Alzheimer's Disease
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov