What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include pharmacologic therapies like cholinesterase inhibitors and non-pharmacologic therapies such as cognitive behavioral therapy and neuromodulation techniques. Specifically, treatments similar to the Light and Sound Stimulation Device, which boosts gamma waves, include transcranial magnetic stimulation (TMS) and repetitive transcranial magnetic stimulation (rTMS). Known side effects of these neuromodulation techniques are generally mild and may include lightheadedness, tingling, and tinnitus. Long-term safety data is still limited, and larger trials are needed to fully understand the potential risks and benefits.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on symptom management and slowing disease progression. Notably, aducanumab (Aduhelm) was approved for its ability to reduce amyloid plaques in the brain, a hallmark of Alzheimer's. Other treatments include cholinesterase inhibitors like donepezil (Aricept) and NMDA receptor antagonists like memantine (Namenda), which help manage symptoms but do not directly target amyloid or tau deposits. While the Light and Sound Stimulation Device is still under study, it represents a novel approach by aiming to boost gamma waves to reduce amyloid and tau deposits, potentially offering a new avenue for treatment.

What other types of research exist?

Promising novel alternatives to the Light and Sound Stimulation Device for Alzheimer's Disease patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in reducing cognitive decline and improving memory by modulating brain activity. 2) Transcutaneous Supraorbital Nerve Stimulation, which has been effective in other neurological conditions and may offer benefits for AD by enhancing neural function. 3) Remote Electrical Neuromodulation, which uses nonpainful electrical stimulation to potentially improve cognitive function and reduce amyloid deposits.

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Behavioural Intervention

GENUS Stimulation to Prevent Alzheimer's Disease

N/A

Recruiting

Led By Diane Chan, MD PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Summary

This trial tests a light and sound device that creates brain waves at 40Hz. It targets people aged 55+ with a family history of Alzheimer's disease. The device aims to boost brain waves to reduce harmful proteins and improve memory.

Who is the study for?

This trial is for cognitively normal people aged 55-90 with a family history of Alzheimer's, who have certain scores on memory and mental state exams, and specific brain amyloid levels. They must be able to undergo MRI/PET scans, have good vision and hearing for tests, and can't be pregnant or have severe illnesses that affect study participation.

What is being tested?

The GENUS device uses light and sound at 40Hz to stimulate gamma waves in the brain. The study aims to see if this stimulation can prevent dementia in those at risk for Alzheimer's by reducing toxic proteins in the brain associated with memory loss.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from wearing the device or sensitivity to light/sound stimuli. Regular monitoring during the trial will help identify any adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in brain amyloid deposition over the study period, as measured by PiB PET.

Secondary study objectives

Change from baseline in CSF levels of amyloid and tau.

Changes in blood biomarkers of AD

Changes in brain connectivity by functional MRI

+5 more

Other study objectives

Change from baseline in activity levels

Change from baseline in gamma oscillations as measured by EEG

Change from baseline in integrity of white matter tracks and myelination as measured by diffusion MR imaging.

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active GENUS light and soundActive Control1 Intervention

The device is a light and sound device that delivers light stimulation using light-emitting diodes (LED) and sound stimulation through a speaker, with a centrally-mounted tablet that plays videos for entertainment. The device will be positioned on an easel such that the tablet is eye level with the participant while they are sitting 5 feet away. The active device delivers light and sound at 40Hz rate.

Group II: Sham GENUS light and soundPlacebo Group1 Intervention

The device is the same as the active device but it delivers light and sound at different frequencies.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and memantine. Cholinesterase inhibitors work by increasing cholinergic transmission, which helps improve cognition and global functioning by preventing the breakdown of acetylcholine, a neurotransmitter important for memory and learning. Memantine, on the other hand, regulates glutamate activity to prevent excitotoxicity, which can damage neurons. These treatments are crucial for AD patients as they provide symptomatic relief and help maintain cognitive function. Similar to the Light and Sound Stimulation Device, which aims to reduce amyloid and tau deposits by boosting gamma waves, these treatments focus on improving neurotransmitter function and protecting neurons, thereby addressing some of the underlying pathophysiological processes of AD.