Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05776641
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-11-29
Brief Title:
Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimers Disease
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Prevention of Alzheimers Disease Using Gamma Entrainment
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alzheimers 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 Gamma waves are important for memory and in patients with AD there are fewer gamma waves in the brain The Tsai 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 A light and sound device was developed for humans that stimulates the brain at 40Hz that can be used safely at home The goal of this study is to see if using this device can prevent dementia in people who are at risk for developing Alzheimers disease
Detailed Description:
The investigators are recruiting participants aged 55 with normal memory who have or had a close family member with Alzheimers disease 200 participants will undergo a blood test and a subset will undergo an amyloid PET scan and only 50 participants who have cerebral amyloid deposits will continue in the study Neither the participant nor the investigators will know whether the participant is receiving sham or active stimulation Participants will use the device for 12 months at home for 60 minutes each day when they are awake Participants will come to the Massachusetts General Hospital in Boston for 4-6 visits before starting the stimulation at 6 months and after 12 months of usage The participants will undergo PET scans MRI EEG blood tests and memory tests and questionnaires at each visit to monitor progress In addition people may elect to allow for us to study their cerebral spinal fluid Participants will also wear a fitbit like watch to monitor sleep and activity throughout the study The goal of this study is to evaluate whether stimulation with our device at 40Hz will reduce AD pathology in the brain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None