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NCT05655195 · ClinicalTrials.gov registry record · NA
Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy
A NA study of Alzheimer Disease and Alzheimers Disease, sponsored by Massachusetts Institute of Technology.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05655195 is a NA study of Alzheimer Disease and Alzheimers Disease that is actively recruiting participants, run by Massachusetts Institute of Technology. The registered enrollment target is 50 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05655195, a NA study of Alzheimer Disease and Alzheimers Disease, is actively recruiting participants, sponsored by Massachusetts Institute of Technology.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- DEVICE GENUS device (Active Settings)
- DEVICE GENUS device (sham settings)
Study Locations (1)
Massachusetts
- Massachusetts Institute of Technology - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2026-09-01 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The listed sponsor is Massachusetts Institute of Technology, which has 24 total studies on file at ClinicalTrials.gov.
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.
NCT05655195 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
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, Alzheimers Disease, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer's Disease (Incl Subtypes).
What interventions are being tested in trial NCT05655195?
The interventions under investigation include: GENUS device (Active Settings) (DEVICE), GENUS device (sham settings) (DEVICE).
Who is sponsoring clinical trial NCT05655195?
This trial is sponsored by Massachusetts Institute of Technology, which has 24 total clinical trials registered on ClinicalTrials.gov.
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.
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