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Recruiting NCT05655195

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

Conditions: Alzheimer Disease, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer's Disease (Incl Subtypes), Alzheimer's, Alzheimer's Disease

Sex: All
Ages: 50 Years – 100 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: Massachusetts Institute of Technology

Location: United States

Summary

Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. The investigator's lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. The investigators developed a light and sound device for humans that stimulates the brain at 40Hz that can be used safely at home. For the present study, 50 participants with mild Alzheimer's disease will be enrolled and will use this light and sound device at-home daily for 6-months. Investigators will measure changes in brain waves with EEG, blood biomarkers, the microbiome via fecal samples, functional and structural MRI scans, memory and cognitive testing, and questionnaires at 3 in-person visits throughout the study. After the 6-month time point, participants will have the option of continuing in the study for one additional year and completing an 18-month study visit. This study will provide critical insight into extended therapy involving non-invasive 40Hz sensory stimulation as a possible therapeutic strategy for mild to moderate Alzheimer's disease.

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 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.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 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.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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05655195). StuddyBuddy aggregates publicly available trial information.