50 Participants Needed

Gamma Light and Sound Therapy for Alzheimer's Disease

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Overseen ByRemi Philips, BA
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts Institute of Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as amyloid reducing therapy, NMDA receptor antagonists like Memantine, and medications that lower the seizure threshold. If you are on psychiatric medications, you must be on a stable dose for at least three months before joining the trial.

What data supports the effectiveness of the Gamma Light and Sound Therapy treatment for Alzheimer's Disease?

Research shows that 40 Hz sensory therapy, which includes light and sound, has improved cognitive scores in some Alzheimer's patients and is considered safe. Animal studies also suggest it may reduce Alzheimer's-related brain changes, and some participants reported benefits from the therapy.12345

Is Gamma Light and Sound Therapy safe for humans?

Small studies in humans have shown that 40 Hz sensory therapy using light and sound is safe and tolerable, with no reported side effects. Further research is needed to explore its effectiveness and feasibility.12367

How is the GENUS device treatment different from other Alzheimer's treatments?

The GENUS device treatment is unique because it uses non-invasive light and sound therapy at 40 Hz to stimulate brain activity, which may help improve cognitive function and daily living activities in Alzheimer's patients. Unlike traditional drug treatments, this therapy aims to restore normal brain oscillations and has shown promise in both animal and early human studies without reported side effects.13589

What is the purpose of this trial?

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.

Research Team

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Li Huei Tsai, PhD

Principal Investigator

Massachusetts Institute of Technology

Eligibility Criteria

This trial is for individuals aged 50-100 with mild Alzheimer's disease, having an MMSE score of 19-26. They must be able to give consent or have a representative do so and complete the first month at their primary residence. Excluded are those without healthcare, on certain Alzheimer's medications, unstable psychiatric treatments, seizure history within two years, significant suicide risk, behavioral issues affecting compliance, recent stroke or eye surgery candidates.

Inclusion Criteria

If I can't consent, someone legally allowed will do it for me.
I am between 50 and 100 years old.
I have mild Alzheimer's with a specific cognitive test score.
See 2 more

Exclusion Criteria

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 with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol
Subjects who have >3 microbleeds/microhemmorhages in their brain
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a gamma light and sound device at-home daily for 6 months, with 3 in-person visits for assessments

6 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment for one additional year with guaranteed 40Hz active treatment

12 months
1 visit (in-person) at 18 months

Treatment Details

Interventions

  • GENUS device
Trial Overview The study tests a device called GENUS that uses light and sound at 40Hz aimed to stimulate brain waves in people with mild Alzheimer's disease. Participants will use this device daily for six months at home while undergoing various assessments including EEGs, MRIs, cognitive tests and questionnaires to evaluate its effects on brain function and memory.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Alzheimer's Active ArmActive Control1 Intervention
Exposure to active sensory stimulation (40Hz) for 60 minutes daily for the length of the trial (6 months).
Group II: Alzheimer's Control ArmPlacebo Group1 Intervention
Exposure to control stimulation (sham) for 60 minutes daily for the length of the trial (6 months).

GENUS device is already approved in United States for the following indications:

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Approved in United States as 40Hz Light and Sound Therapy for:
  • Alzheimer's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts Institute of Technology

Lead Sponsor

Trials
104
Recruited
12,810,000+

Findings from Research

Gamma Entrainment Using Sensory stimulation (GENUS) shows promise as a non-pharmacological treatment for Alzheimer's disease, with animal studies indicating it can positively affect cognitive decline and reduce amyloid plaques and neurofibrillary tangles.
Although research on GENUS in humans is still in early stages, initial findings suggest it is feasible and warrants further investigation to establish its effectiveness as a disease-modifying intervention.
An update on the use of gamma (multi)sensory stimulation for Alzheimer's disease treatment.Manippa, V., Palmisano, A., Filardi, M., et al.[2023]
A study involving 10 patients with mild cognitive impairment due to Alzheimer's disease demonstrated that daily 1-hour sessions of gamma flicker stimulation (40 Hz) were safe, well-tolerated, and adhered to over 4 to 8 weeks.
Preliminary results indicated that this gamma flicker stimulation may positively influence neural activity and immune factors in the nervous system, suggesting potential benefits for further research in Alzheimer's treatment.
A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease.He, Q., Colon-Motas, KM., Pybus, AF., et al.[2022]
A non-invasive 40 Hz sensory therapy using light and sound was found to be safe and tolerable in a small group of 27 participants with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD), with 11 completing 6 months of therapy.
Some participants showed cognitive improvements, with 2 out of 4 with subjective complaints and 2 out of 6 with AD improving their Montreal Cognitive Assessment (MOCA) scores, suggesting potential benefits of this therapy that warrant further investigation.
A Feasibility Study of AlzLife 40 Hz Sensory Therapy in Patients with MCI and Early AD.McNett, SD., Vyshedskiy, A., Savchenko, A., et al.[2023]

References

An update on the use of gamma (multi)sensory stimulation for Alzheimer's disease treatment. [2023]
A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease. [2022]
A Feasibility Study of AlzLife 40 Hz Sensory Therapy in Patients with MCI and Early AD. [2023]
Research Note: A self-luminous light table for persons with Alzheimer's disease. [2020]
Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. [2022]
Photobiomodulation for Alzheimer's Disease: Translating Basic Research to Clinical Application. [2021]
Neuroprotective effect of a new photobiomodulation technique against Aβ25-35 peptide-induced toxicity in mice: Novel hypothesis for therapeutic approach of Alzheimer's disease suggested. [2022]
Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. [2021]
Gamma Entrainment in a Large Retrospective Cohort: Implications for Photic Stimulation Therapy for Alzheimer's Disease. [2021]
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