Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy

Launched by MASSACHUSETTS INSTITUTE OF TECHNOLOGY · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new therapy for people with mild Alzheimer's disease using a device that combines light and sound to stimulate the brain at a specific frequency. Previous research in mice showed that this 40Hz stimulation could help reduce harmful proteins in the brain and improve memory. In this study, 60 participants aged 65 to 100 with mild Alzheimer's will use this device at home every day for six months. During this time, researchers will monitor brain activity and memory through tests and scans at three in-person visits.

To join the study, participants need to be between 65 and 100 years old and have mild Alzheimer's disease, as shown by a specific memory test score. They must be willing to participate and complete the daily stimulation at their home. It's important to note that those with certain medical conditions or treatments will not be eligible. At the end of the six months, participants may have the option to continue in the study for an additional year. This research aims to explore whether this non-invasive therapy could be a helpful option for managing mild to moderate Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects may be enrolled into the study if they meet all of the following criteria:
• • Subject is between the ages of 65 - 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.
• • Able to complete the 1st month of at home stimulation at their primary residence. If subjects plan to spend more than 1 week away from their primary residence during the trial, their inclusion must be assessed by the research team.
• Exclusion Criteria:
• Subjects who meet any of the following conditions will not be enrolled in the study:
• • Subjects who do not have healthcare.
• • Subjects who are currently taking amyloid reducing therapy.
• • Subjects who have \> 4 cerebral microbleeds or 1 macrobleed in their brain
• • Active treatment on a dosage of one or more psychiatric agents (e.g. antidepressants, antipsychotics, etc) for LESS THAN three months (a stable dose for greater than or equal to three months is ok).
• • Subjects who are actively diagnosed with cancer and undergoing cancer-related treatments
• • 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
• • 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 with untreated or unstable depression
• • Active treatment with one or more anti-epileptic agent.
• • Subjects who have had a stroke within the past 24 months.
• • Subjects who have had eye surgery in the last 3 months or are scheduled to have eye surgery in the next 6 months (during the study)
• • Subjects diagnosed with migraine headache.
• • 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.
• • Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.

Trial Officials