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Brain Stimulation for Alzheimer's Disease

N/A
Waitlist Available
Led By Li-Huei Tsai, PhD
Research Sponsored by Massachusetts Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is between the ages of 50 - 100
Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26
Must not have
Subjects with history of seizure or epilepsy within the past 24 months
Subjects diagnosed with migraine headache
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the completion of the stimulation

Summary

This trial will test whether a non-invasive brain stimulation technique can remove toxic proteins and improve memory in people with mild Alzheimer's disease.

Who is the study for?
This trial is for individuals aged 50-100 with mild Alzheimer's Disease, having a Mini Mental State Exam score of 19-26. Participants must consent to the study; if unable, a legal representative can consent for them. Excluded are those without healthcare, on certain medications like NMDA antagonists or anti-seizure drugs, recent stroke survivors, pregnant women, and those with severe hearing or visual impairments.
What is being tested?
The GENUS device is being tested in this trial. It uses light and sound stimulation aimed at improving brain functions in patients with mild Alzheimer's disease. The study will monitor brain waves before, during, and after using the device to evaluate safety and effectiveness.
What are the potential side effects?
Since this is a non-invasive treatment involving light and sound stimulation designed to improve cognitive function in Alzheimer's patients, side effects may be minimal but are not detailed in the provided information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 100 years old.
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My Alzheimer's is mild, with an MMSE score between 19 and 26.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a seizure or been diagnosed with epilepsy in the last 2 years.
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I have been diagnosed with migraine.
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I am currently taking medication for a mental health condition.
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I have severe hearing or vision loss.
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I am currently taking medication for epilepsy.
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I am currently taking medication that affects NMDA receptors.
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I am taking medications that may increase my risk of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and immediately after the completion of the stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and immediately after the completion of the stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of gamma frequency stimulation
Safety of gamma frequency stimulation
Tolerability of gamma frequency stimulation
Other study objectives
Changes in working memory after gamma frequency stimulation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exposure to active stimulation for 30 - 60 minExperimental Treatment1 Intervention
Subjects in this arm will receive 30 - 60 minutes of active stimulation
Group II: Exposure to control stimulation for 30 - 60 minPlacebo Group1 Intervention
Subjects in this arm will receive 30 - 60 minutes of control stimulation

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor
98 Previous Clinical Trials
12,819,907 Total Patients Enrolled
Li-Huei Tsai, PhDPrincipal InvestigatorMassachusetts Institute of Technology
3 Previous Clinical Trials
115 Total Patients Enrolled
Diane Chan, MD, PhDPrincipal InvestigatorMassachusetts Institute of Technology
2 Previous Clinical Trials
75 Total Patients Enrolled
~16 spots leftby Apr 2026