Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Dementia
About this trial
This is an interventional treatment trial for Alzheimer Disease, Early Onset focused on measuring Dementia, Alzheimer's Disease, Memory Loss
Eligibility Criteria
Inclusion Criteria:
- >= 50 Years Old
- MMSE 24 - 30
- Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- Participation of a caregiver / care partner
- Amyloid Positive PET Scan
Exclusion Criteria:
- Profound hearing or visual impairment
- Seizure Disorder
- Use of memantine (Namenda or Namzaric)
- Implantable devices (non-MR compatible)
Sites / Locations
- Boston Center for Memory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort 1, Arm A
Cohort 1, Arm B
Cohort 2, Arm C
Cohort 2, Arm D
Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)
Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)
Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)
Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)