High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

Alzheimer's disease (AD) is characterized by significant memory loss and toxic protein deposits (amyloid and tau) in the brain. The investigators' lab found a non-invasive way to remove these toxic proteins from the brain in AD mouse models. Remarkably, treated mice also have improved memory on behavioral testing. The investigators aim to translate this non-invasive method, which uses light and sound to stimulate the brain, to be used in mild Alzheimer's patients. 40 participants with mild Alzheimer's disease will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) before, during, and after light and sound stimulation for safety, feasibility, and to optimize the stimulation device for use in the mild AD population.

Key facts

Study ID

NCT04042922

Run by

Massachusetts Institute of Technology

People needed

80

Starts

2019-04-19

Expected to finish

2027-04-30

Last updated by the study team

2024-10-01

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subject is willing to sign informed consent document.
• If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.

You may not qualify if…

• Subjects who do not have healthcare.
• Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
• Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
• Subjects with history of seizure or epilepsy within the past 24 months.
• Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
• Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
• Active treatment with one or more anti-epileptic agent.
• Subjects who have had a stroke within the past 24 months.
• Subjects diagnosed with migraine headache.
• Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
• Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
• Subjects who have profound hearing or visual impairment.
• Subjects who have a life expectancy of less than 2 years.
• Subjects who are pregnant.

Where it is running

• Massachusetts Institute of Technology — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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