Using light and sound therapy to treat Alzheimer's disease

Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation

This study is testing whether a light and sound device can help people with mild Alzheimer's disease improve their memory and brain function over six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 65 Years to 100 Years
• Sex: All
• Sponsor: Massachusetts Institute of Technology (Academic / other)
• Locations: 1 site (Cambridge, Massachusetts)
• Trial ID: NCT05655195 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a light and sound device that stimulates the brain at 40Hz on individuals with mild Alzheimer's disease. Participants will use the device at home daily for six months, with their progress monitored through EEG, blood tests, microbiome analysis, MRI scans, and cognitive assessments during three in-person visits. The goal is to determine if this therapy can enhance gamma wave activity in the brain, reduce toxic protein deposits, and improve memory function. The study aims to recruit 60 participants, including a small cohort of early-onset Alzheimer's patients.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 65-100 with a diagnosis of mild Alzheimer's disease and an MMSE score between 19-26.

Not a fit: Patients currently on amyloid-reducing therapy or those with significant cerebral microbleeds may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel, non-invasive treatment option for improving cognitive function in Alzheimer's patients.

How similar studies have performed: While this approach is innovative, previous studies have shown promise in using light and sound stimulation to enhance gamma wave activity in animal models, but human applications are still largely untested.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Subjects who meet any of the following conditions will not be enrolled in the study:

* Subjects who do not have healthcare.
* Subjects who are currently taking amyloid reducing therapy.
* Subjects who have \> 4 cerebral microbleeds or 1 macrobleed in their brain
* 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 who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
* Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
* Subjects with history of seizure or epilepsy
* 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
* Active treatment with one or more anti-epileptic agent.
* Subjects who have had a stroke within the past 24 months.
* 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)
* Subjects diagnosed with migraine headache.
* 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.
* Subjects who have a life expectancy of less than 2 years.
* Subjects who are pregnant.
* 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.

Where this trial is running

Cambridge, Massachusetts

• Massachusetts Institute of Technology — Cambridge, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Li Huei Tsai, PhD — Massachusetts Institute of Technology
• Study coordinator: gamma wave

Conditions Alzheimer Disease; Alzheimer Disease, Early Onset; Alzheimer Disease, Late Onset; Alzheimer's Disease; Alzheimer's; Alzheimer; Alzheimer's disease; Light and Sound Stimulation