WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
Reason given: funding purposes
Key facts
- Where
- Boca Raton, Chapel Hill, Hampton, Tampa, and Winston-Salem, United StatesSee the 5 sites
Where in United States
- Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, United StatesNo longer taking part
- University of North Carolina at Chapel HillChapel Hill, United StatesNo longer taking part
- Riverside Neurology SpecialistsHampton, United StatesNo longer taking part
- USF Health Byrd Alzheimer's InstituteTampa, United StatesNo longer taking part
- Wake Forest University Health SciencesWinston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- Scion NeuroStim
- Trial code
- NCT05032482
- Record updated
- 13 May 2024
- Original description
This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).Read full original descriptionShow less
This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).
Inclusion: 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.
Exclusion: 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.