150 Participants NeededMy employer runs this trial

Gamma Frequency Sensory Stimulation for Alzheimer's Disease

(GENUS Trial)

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Overseen ByAna Trisini Lipsanopoulos, BS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts Institute of Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called GENUS to determine if it can slow memory and thinking problems in people with Alzheimer's disease. The device uses a type of brain stimulation to assess its effects on brain activity and safety. Participants will visit MIT for one day to undergo various tests, including brain scans and memory tests. The trial suits those who are healthy, have no history of seizures, and do not have metal implants that could interfere with MRI scans. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the chance to contribute to important advancements in Alzheimer's care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

What prior data suggests that this device is safe for use in cognitively normal adults?

Research has shown that GENUS, a device using 40Hz sound and light stimulation, is generally safe for people. Studies have found that most individuals tolerate this treatment well without serious side effects. Some mild issues, such as dizziness, headaches, or ringing in the ears, have been reported, but these are uncommon. One study found that using GENUS daily for up to two years is safe and doesn't cause major problems. This suggests that GENUS could be a suitable option for those considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Most treatments for Alzheimer's disease focus on managing symptoms or slowing progression through medication, like cholinesterase inhibitors and memantine. However, GENUS (Gamma ENtrainment Using Sensory) is unique because it targets the brain's gamma frequency oscillations, which are believed to be disrupted in Alzheimer's patients. This non-invasive technique uses sensory stimulation, like light and sound, to potentially restore these brain rhythms. Researchers are excited about GENUS because it offers a novel approach that could improve cognitive function by addressing the underlying neural activity, rather than just alleviating symptoms.

What evidence suggests that this device is effective for Alzheimer's Disease?

Research has shown that GENUS, a treatment using specific sound and light patterns, may aid in managing Alzheimer's disease. Studies have found that 40 Hz stimulation can reduce harmful brain proteins, such as amyloid and tau. Other research indicates that GENUS can enhance memory and cognitive skills. Some trials reported improvements in sleep and daily functioning after several weeks of treatment. These findings suggest that GENUS might slow memory and cognitive decline in Alzheimer's patients. Participants in this trial will receive GENUS to further evaluate its effects.13678

Who Is on the Research Team?

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Ana Trisini Lipsanopoulos, BS

Principal Investigator

Massachusetts Institute of Technology

Are You a Good Fit for This Trial?

This trial is for adults who are either cognitively healthy or have Alzheimer's disease. Participants must be able to see and hear well enough for light and sound stimulation, and be able to complete memory and thinking tests.

Inclusion Criteria

I can see and hear well enough to take part in mental function tests.
* Be able to comply with neuropsychological testing and other study procedures in opinion of site PI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive a single session of 40Hz sensory stimulation to evaluate effects on brain activity, connectivity, neuropsychological measures, blood biomarkers, and the microbiome.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations of brain oscillations, microbiome, blood biomarkers, and neuropsychiatric measures over a 1-year period.

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • GENUS

Trial Overview

The study is testing GENUS devices that use 40Hz light, sound, or touch stimulation to see their effects on the brain. It involves a single-day visit with brain scans, cognitive tests, and blood samples at MIT.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cognitively normal adultsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts Institute of Technology

Lead Sponsor

Trials
104
Recruited
12,810,000+

Citations

Gamma sensory stimulation in mild Alzheimer's dementia - PMC

Another trial reported improved sleep quality and activities of daily living in AD patients after 4–8 weeks of 40 Hz stimulation, suggesting ...

An update on the use of gamma (multi)sensory stimulation ...

Therefore Gamma Entrainment Using Sensory stimulation (GENUS) is among the most promising approaches for AD patients' treatment. This review ...

Brain Effects of Gamma Frequency Sensory Stimulation ...

40Hz gamma frequency stimulation was previously shown to reduce Alzheimer's disease pathology and improve cognitive outcomes. This study aims to ...

Gamma frequency sensory stimulation in mild probable ...

Non-invasive Gamma ENtrainment Using Sensory stimulation (GENUS) at 40Hz reduces Alzheimer's disease (AD) pathology such as amyloid and tau levels, prevents ...

The safety and efficacy of gamma frequency auditory and ...

Noninvasive gamma sensory stimulation may reduce white matter and myelin loss in Alzheimer's disease. Journal of Alzheimer's Disease. 2024 ...

GENUS Study: Can we prevent Alzheimer's disease using ...

Our work shows that our device, GENUS, is well tolerated and can slow down progression of disease in patients with mild AD. Since our device is safe and so easy ...

Gamma frequency sensory stimulation prevents brain atrophy ...

Gamma frequency light and sound stimulation can be used safely daily for 3 months and prevents AD-related degeneration. Induced entrainment ...

Gamma frequency sensory stimulation in mild probable ...

Electroencephalography recordings show that our 40Hz GENUS device safely and effectively induced 40Hz entrainment in participants with mild AD dementia. ... These ...