WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Ki vehet részt

• Adult participants (aged 65 - 85 years inclusive) diagnosed with probable Alzheimer's disease dementia
• Willing and able to comply with study requirements
• Have a study partner who sees the participant for more than three hours a day, 5x per week and is that is willing to consent and participate in the trial
• Anticipation that the participant is able to remain on a stable regimen of medications used for the management of Alzheimer's disease and will not introduce new medications used to treat Alzheimer's disease during the study
• Participant and study partner must both be fully vaccinated from COVID-19 prior to the study screen

Ki nem vehet részt

• Were diagnosed with probable Alzheimer's disease prior to 65 years of age
• Are being treated with another neurostimulation device
• Have unresolved complications from a previous surgical procedure at the baseline visit, such as swelling or persistent pain, that requires medical intervention
• Have a cochlear implant or hearing aids that cannot be easily/reliably removed for treatment
• Have previously been diagnosed with traumatic brain injury with ongoing sequela
• Has experienced a heart attack, angina, or stroke within the past 12 months or a transient ischemic attack (TIA) within the past 6 months
• Have active ear infections, or other significant ear problems
• Have a recent history of frequent ear infections
• History of medication-refractory depression or bipolar disorder in the past three years
• History of schizophrenia
• Participation in an interventional clinical trial for any medical or psychiatric indications within 3 months of the screening visit, or at any time during the study
• Experience frequent falls
• Works night shifts
• Have chronic tinnitus