Who is eligible for clinical trial NCT04042922?

Participants must meet protocol criteria for Alzheimer Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04042922 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-09-27

High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease (NCT04042922)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Massachusetts Institute of Technology

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (15 items).

Location: Massachusetts Institute of Technology — Cambridge, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Massachusetts Institute of Technology — Cambridge, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗