200 Participants Needed
Massachusetts General Hospital logo

GENUS Stimulation to Prevent Alzheimer's Disease

Recruiting in Cambridge (>99 mi)
+1 other location
MC
Gd
KA
MQ
DC
Overseen ByDiane Chan, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants do not take NMDA antagonists. If you are undergoing a lumbar puncture, you cannot use warfarin or similar blood thinners. Other medications are not specifically mentioned, so check with the study team for more details.

Is GENUS (Gamma Entrainment Using Sensory stimulation) safe for humans?

Studies show that GENUS, which uses 40Hz light and sound stimulation, is generally safe and well-tolerated in humans, including those with mild Alzheimer's disease. Participants in trials experienced no significant adverse effects, and the treatment was well-received over periods of up to six months.12345

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

GENUS is unique because it uses non-invasive sensory stimulation with light and sound at 40Hz to improve brain function and reduce Alzheimer's disease markers, unlike traditional drug treatments. This approach aims to restore normal brain rhythms and improve cognitive and daily living activities without medication.12346

What data supports the effectiveness of the treatment GENUS, Gamma Entrainment Using Sensory stimulation, 40Hz Light and Sound Stimulation, in preventing Alzheimer's disease?

Research shows that GENUS, which uses 40Hz light and sound stimulation, can reduce Alzheimer's disease markers like amyloid and tau in mice, and improve memory and daily activities in humans with mild Alzheimer's. Studies also found that this treatment is safe, well-tolerated, and can improve brain connectivity and reduce brain shrinkage in patients.12347

Who Is on the Research Team?

DC

Diane Chan, MD PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to comply with neuropsychological testing and other study procedures in opinion of site PI
My immediate family has a history of Alzheimer's disease.
Delayed Recall score on the Logical Memory IIa subtest of 8 to 15 at baseline or expected score range for cognitively normal adjusted for education level
See 10 more

Exclusion Criteria

Laboratory findings, if known (study does not perform testing) suggestive of systemic illness such as renal disease
I have a brain condition like fluid buildup or a tumor.
I don't have bleeding disorders or low platelet levels if I agree to undergo a lumbar puncture.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants use the GENUS light and sound device at home for 12 months, 60 minutes each day

12 months
4-6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • GENUS
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Active GENUS light and soundActive Control1 Intervention
Group II: Sham GENUS light and soundPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as GENUS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Massachusetts Institute of Technology

Collaborator

Trials
104
Recruited
12,810,000+

Published Research Related to This Trial

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 6-month study involving 22 patients with mild to moderate Alzheimer's disease showed that daily 40 Hz gamma sensory stimulation therapy was well tolerated and helped maintain functional abilities, unlike the sham group which experienced a decline.
Patients receiving the active treatment had improved sleep quality, as indicated by reduced nighttime activity, suggesting that gamma sensory stimulation may have beneficial effects on both sleep and cognitive function in Alzheimer's patients.
Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients.Cimenser, A., Hempel, E., Travers, T., et al.[2021]
Gamma entrainment through non-invasive auditory stimulation at 40 Hz has shown potential in enhancing beta amyloid uptake and improving cognitive symptoms in Alzheimer's disease, making it a promising therapeutic approach.
A study involving 13 elderly participants with memory complaints recorded EEG signals during auditory stimulation, providing valuable data for understanding brain oscillatory activity and its implications for dementia treatment.
Non-invasive auditory brain stimulation for gamma-band entrainment in dementia patients: An EEG dataset.Lahijanian, M., Sedghizadeh, MJ., Aghajan, H., et al.[2022]

Citations

An update on the use of gamma (multi)sensory stimulation for Alzheimer's disease treatment. [2023]
Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. [2021]
Non-invasive auditory brain stimulation for gamma-band entrainment in dementia patients: An EEG dataset. [2022]
Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. [2023]
Enhancement of the neural response during 40 Hz auditory entrainment in closed-eye state in human prefrontal region. [2023]
Cognitive tasks propagate the neural entrainment in response to a visual 40 Hz stimulation in humans. [2022]
Gamma-patterned sensory stimulation reverses synaptic plasticity deficits in rat models of early Alzheimer's disease. [2023]
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