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RECRUITING NA

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

NCT05655195 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE GENUS device (Active Settings)
  • DEVICE GENUS device (sham settings)

Study Locations (1)

Massachusetts

  • Massachusetts Institute of Technology — Cambridge

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2022-12-14
Est. Completion 2026-09-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05655195

The ClinicalTrials.gov registry entry for NCT05655195 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Institute of Technology, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions — of which GENUS device (Active Settings) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05655195 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05655195 about?

NCT05655195 is a clinical study titled "Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy". 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 red...

What is the current status of trial NCT05655195?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-12-14. Estimated completion is 2026-09-01.

What conditions does trial NCT05655195 study?

This clinical trial studies the following conditions: Alzheimer Disease, Alzheimer's Disease, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer's Disease (Incl Subtypes). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05655195?

The interventions under investigation include: GENUS device (Active Settings) (DEVICE), GENUS device (sham settings) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05655195?

This trial is sponsored by Massachusetts Institute of Technology, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05655195 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial