NCT04042922Active, not recruiting
High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease
Acute Treatment of Alzheimer's Disease With Gamma Frequency Stimulation
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 24 Jul 2019
- Start date
- 19 Apr 2019
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Massachusetts Institute of Technology
- Diseases
- Alzheimer disease
- NCT number
- NCT04042922
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 19 Apr 2019 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
- Active treatment with one or more anti-epileptic agent.
- Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
Other illness
- 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 who have had a stroke within the past 24 months.
- 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.
Other
- Subjects who do not have healthcare.
- 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.
- Subjects diagnosed with migraine headache.
- Subjects who have a life expectancy of less than 2 years.
- Subjects who are pregnant.
Who the study is looking for
- 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.
Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts Institute of Technology Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.