NCT05655195Recruiting
Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy
Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Oct 2022
- Start date
- 14 Dec 2022
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Massachusetts Institute of Technology
- Diseases
- Alzheimer disease
- NCT number
- NCT05655195
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 14 Dec 2022 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are currently taking amyloid reducing therapy.
- Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
- Active treatment with one or more anti-epileptic agent.
- Subjects who have had eye surgery in the last 3 months or are scheduled to have eye surgery in the next 6 months (during the study)
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.
Other illness
- Subjects who meet any of the following conditions will not be enrolled in the study:
- Active treatment on a dosage of one or more psychiatric agents (e.g. antidepressants, antipsychotics, etc) for LESS THAN three months (a stable dose for greater than or equal to three months is ok).
- Subjects who are actively diagnosed with cancer and undergoing cancer-related treatments
- Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
- Subjects with history of seizure or epilepsy
- Subjects who have had a stroke within the past 24 months.
- Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
- Subjects who have profound hearing or visual impairment.
Other
- Subjects who do not have healthcare.
- Subjects who have \> 4 cerebral microbleeds or 1 macrobleed in their brain
- Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
- Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
- Subjects with untreated or unstable depression
- Subjects diagnosed with migraine headache.
- Subjects who have a life expectancy of less than 2 years.
- Subjects who are pregnant.
Who the study is looking for
- 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.
Age in the registry: 65 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts Institute of Technology Coordinator of this site? Confirm its status | Cambridge | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.