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Behavioural Intervention

GENUS Stimulation to Prevent Alzheimer's Disease

N/A
Recruiting
Led By Diane Chan, MD PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

Study Summary

This trial is testing a device that stimulates the brain with light/sound to reduce toxic proteins & boost memory in people at risk of Alzheimer's.

Who is the study for?
This trial is for cognitively normal people aged 55-90 with a family history of Alzheimer's, who have certain scores on memory and mental state exams, and specific brain amyloid levels. They must be able to undergo MRI/PET scans, have good vision and hearing for tests, and can't be pregnant or have severe illnesses that affect study participation.Check my eligibility
What is being tested?
The GENUS device uses light and sound at 40Hz to stimulate gamma waves in the brain. The study aims to see if this stimulation can prevent dementia in those at risk for Alzheimer's by reducing toxic proteins in the brain associated with memory loss.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from wearing the device or sensitivity to light/sound stimuli. Regular monitoring during the trial will help identify any adverse reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in brain amyloid deposition over the study period, as measured by PiB PET.
Secondary outcome measures
Change from baseline in CSF levels of amyloid and tau.
Changes in blood biomarkers of AD
Changes in brain connectivity by functional MRI
+5 more
Other outcome measures
Change from baseline in activity levels
Change from baseline in gamma oscillations as measured by EEG
Change from baseline in integrity of white matter tracks and myelination as measured by diffusion MR imaging.
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active GENUS light and soundActive Control1 Intervention
The device is a light and sound device that delivers light stimulation using light-emitting diodes (LED) and sound stimulation through a speaker, with a centrally-mounted tablet that plays videos for entertainment. The device will be positioned on an easel such that the tablet is eye level with the participant while they are sitting 5 feet away. The active device delivers light and sound at 40Hz rate.
Group II: Sham GENUS light and soundPlacebo Group1 Intervention
The device is the same as the active device but it delivers light and sound at different frequencies.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,441 Total Patients Enrolled
Massachusetts Institute of TechnologyOTHER
97 Previous Clinical Trials
12,729,787 Total Patients Enrolled
Diane Chan, MD PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

GENUS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05776641 — N/A
Alzheimer's Disease Research Study Groups: Active GENUS light and sound, Sham GENUS light and sound
Alzheimer's Disease Clinical Trial 2023: GENUS Highlights & Side Effects. Trial Name: NCT05776641 — N/A
GENUS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05776641 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients within the scope of this clinical trial?

"The present medical study is seeking individuals aged between 55 and 90 years old."

Answered by AI

What criteria must be met to join this research endeavor?

"To be accepted for admission to this research study, applicants must have been diagnosed with Alzheimer's disease and at least 55 years of age but not more than 90. Ultimately, 200 participants are being recruited by the clinical trial."

Answered by AI

Is this experiment still in need of volunteer participants?

"Affirmative. Clinicaltrials.gov's information indicates that this research is presently enrolling patients, with the trial having been first published on May 1st 2023 and modified most recently on March 17th 2023. 200 participants must be recruited from one centre."

Answered by AI

How many individuals are contributing to this experiment?

"Affirmative. The clinical trial data hosted on clinicaltrials.gov reveals that this study, which was initially launched on May 1st 2023, is still recruiting participants. Approximately 200 patients are needed from a single medical facility."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimer's Disease
Diane Chan 2024. "Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776641.
All > Alzheimers Disease Boston
~133 spots leftby May 2026
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