RECRUITING

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

Talk to us

Conditions

Alzheimer DiseaseAlzheimer Disease, Early OnsetAlzheimer Disease, Late OnsetAlzheimer's Disease (Incl Subtypes)Alzheimer'sAlzheimer's DiseaseAlzheimerLight and Sound StimulationTactile Stimulation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, 60 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.

Official Title

Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation

Quick Facts

Study Start:2022-12-14
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05655195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is between the ages of 65 - 100.
  2. * Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19-26.
  3. * Subject is willing to sign informed consent document.
  4. * 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.
  5. * 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.
  1. * Subjects who do not have healthcare.
  2. * Subjects who are currently taking amyloid reducing therapy.
  3. * Subjects who have \> 4 cerebral microbleeds or 1 macrobleed in their brain
  4. * 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).
  5. * Subjects who are actively diagnosed with cancer and undergoing cancer-related treatments
  6. * Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
  7. * Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
  8. * Subjects with history of seizure or epilepsy
  9. * Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
  10. * Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
  11. * Subjects with untreated or unstable depression
  12. * Active treatment with one or more anti-epileptic agent.
  13. * Subjects who have had a stroke within the past 24 months.
  14. * 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)
  15. * Subjects diagnosed with migraine headache.
  16. * 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.
  17. * Subjects who have profound hearing or visual impairment.
  18. * Subjects who have a life expectancy of less than 2 years.
  19. * Subjects who are pregnant.
  20. * 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.

Contacts and Locations

Study Contact

Megan Quay, MS
CONTACT
617-258-7723
mcolburn@mit.edu
Diane Chan, MD/PhD
CONTACT
617-258-7723
dchan5@Mgb.org

Principal Investigator

Li Huei Tsai, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology

Study Locations (Sites)

Massachusetts Institute of Technology
Cambridge, Massachusetts, 02142
United States

Collaborators and Investigators

Sponsor: Massachusetts Institute of Technology

  • Li Huei Tsai, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-14
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-12-14
Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's
  • Alzheimer
  • Alzheimer's disease
  • Light and Sound Stimulation
  • Tactile Stimulation

Additional Relevant MeSH Terms

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