Actively Recruiting

Phase Not Applicable
Age: 65Years - 100Years
All Genders
Healthy Volunteers
NCT05655195

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

Led by Massachusetts Institute of Technology · Updated on 2026-03-30

60

Participants Needed

1

Research Sites

193 weeks

Total Duration

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AI-Summary

What this Trial Is About

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 at least one year and completing yearly study visits. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 65 and 100 years old
  • Diagnosed with mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19-26
  • Willing to sign informed consent or have a legally authorized representative provide consent
  • Able to complete the first month of at-home stimulation at their primary residence
  • If planning to be away from primary residence for more than one week during the trial, inclusion must be assessed by the research team
Not Eligible

You will not qualify if you...

  • No healthcare coverage
  • Currently taking amyloid reducing therapy
  • More than 4 cerebral microbleeds or 1 macrobleed in the brain
  • On psychiatric medications for less than three months (stable doses longer than three months are allowed)
  • Actively diagnosed with cancer and undergoing treatment
  • Taking NMDA receptor antagonists (e.g., Memantine)
  • Taking medications that lower seizure threshold (e.g., Wellbutrin, ciprofloxacin, levofloxacin)
  • History of seizure or epilepsy
  • Clinically significant suicide risk or suicide attempt in the past year
  • Behavioral problems interfering with protocol compliance (e.g., aggression, agitation, impulsivity)
  • Untreated or unstable depression
  • Active treatment with anti-epileptic agents
  • Stroke within the past 24 months
  • Eye surgery in the last 3 months or planned in next 6 months
  • Diagnosed with migraine headaches
  • Active implantable medical devices such as ICD, DBS, pacemaker, or sacral nerve stimulator
  • Profound hearing or visual impairment
  • Life expectancy less than 2 years
  • Pregnancy
  • History of neurological disorders other than dementia, including epilepsy, stroke, progressive neurologic diseases, brain lesions, previous neurosurgery, or head trauma with lasting neurological impairment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States, 02142

Actively Recruiting

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Research Team

G

gamma wave

CONTACT

A

Ana Trisini Lipsanopoulos, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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