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?

Despite the huge healthcare and economic impact of AD, there is still no disease modifying therapeutics available. In fact, the available therapeutics show low efficacy at best in the treatment of cognitive impairment in dementia. Development of a non-invasive medical device that is effective in slowing cognitive impairment is not only revolutionary but also possibly cost- effective. In this study, participants will come to MIT for a 1-day visit and the investigators will evaluate the effects of GENUS in cognitively normal, healthy adults. Investigators will use Electroencephalogram (EEG), Magnetoencephalography (MEG), magnetic resonance imaging (MRI), neuropsychological testing, and blood sampling in subsets of participants to evaluate for biological effects and safety of GENUS stimulation.

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?

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

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+