RightFit
RecruitingNot applicable

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

Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years to 100 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Time periods mentioned: 6 months
  • Procedures mentioned: MRI scans, Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "It will take place at the Massachusetts Institute of Technology in Cambridge, MA, and will last 6 months with 3 required visits to the institution: the first at baseline, the second at three months, and the last after six months."
  • "Visits will include blood tests, fecal samples, EEG (using light, sound, and tactile stimulation), MRI, memory and cognitive tests, and questionnaires to monitor progress."
  • "Participants will use the device for six months at home, for 60 minutes each day when they are awake."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether daily light and sound therapy at home may help people ages 65–100 with mild Alzheimer's disease. The device uses light and sound at 40 cycles per second to stimulate brain waves. Participants use it for 6 months and have 3 in-person visits to check memory, brain activity, and other health measures.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 65–100 years old.
  • You have mild Alzheimer's disease and a score of 19–26 on the Mini Mental State Exam (MMSE), a memory and thinking test.
  • You agree to sign a consent form. If you cannot give consent, a legally authorized person must give consent for you.
  • You can do the first month of home treatment at your main home. The study team must review plans to spend more than 1 week away during the study.

Who can't join

  • You do not have health care, are pregnant, or are expected to live less than 2 years.
  • You take treatment that lowers amyloid, a protein that builds up in the brain; an NMDA-blocking drug such as memantine; seizure medicine; or medicine that raises seizure risk, such as Wellbutrin, ciprofloxacin, or levofloxacin.
  • Your dose of medicine for a mental health condition has been stable for less than 3 months. You have untreated or unstable depression, a serious suicide risk, a suicide attempt in the past year, or behavior that could prevent you from following study rules.
  • You have a history of seizures or epilepsy, migraines, or another brain or nerve disorder besides dementia, including stroke, multiple sclerosis, or damaged areas in the brain. Past brain surgery or a head injury with lasting nerve or brain problems also excludes you.
  • You have more than 4 tiny brain bleeds or 1 large brain bleed, or you had a stroke in the past 24 months.
  • You currently have cancer and are getting cancer treatment.
  • You had eye surgery in the past 3 months, plan to have it in the next 6 months, or have severe hearing or vision loss.
  • You have an active medical device inside your body, such as a pacemaker, heart defibrillator, deep brain stimulator, or a device that stimulates nerves in the lower back.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA