WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
- Conditions
- Mild Alzheimer's Disease
- Interventions
- Device: Non-invasive brainstem stimulation
- Registration Number
- NCT05032482
- Lead Sponsor
- Scion NeuroStim
- Brief Summary
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).
- Detailed Description
Up to 45 participants will first enter the double-blind, randomized controlled trial during which they will self-administer treatments twice daily in the home setting over 24 weeks with one of two investigational treatment modes. Participants who complete the randomized controlled trial will then enter the open label extension where all participants will self-administer twice-daily treatments over 24 weeks using the same investigational treatment mode that was reported to show benefit in a previous clinical trial in another neurodegenerative disease.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Were diagnosed with probable Alzheimer's disease prior to 65 years of age.
- Has experienced a heart attack, angina, or stroke within the past 12 months or a transient ischemic attack (TIA) within the past 6 months.
- Are being treated with another neurostimulation device
- Experience frequent falls
- Works night shifts.
- Have unresolved complications from a previous surgical procedure at the baseline visit, such as swelling or persistent pain, that requires medical intervention.
- Have active ear infections, or other significant ear problems.
- Have a recent history of frequent ear infections
- Have a cochlear implant or hearing aids that cannot be easily/reliably removed for treatment.
- Have chronic tinnitus.
- Have previously been diagnosed with traumatic brain injury with ongoing sequela.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational Treatment 1 Non-invasive brainstem stimulation Investigational treatment mode (stimulation pattern) 1 Investigational Treatment Mode - Open Label Non-invasive brainstem stimulation Investigational treatment mode (stimulation pattern) Investigational Treatment 2 Non-invasive brainstem stimulation Investigational treatment mode (stimulation pattern) 2
- Primary Outcome Measures
Name Time Method Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14) 24 weeks The ADAS-Cog-14 is a modified version of the Alzheimer's Disease Assessment Scale - Cognitive Subscale - a brief neuropsychological assessment developed to assess the level of cognitive dysfunction in AD. The scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment.
- Secondary Outcome Measures
Name Time Method Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL). 24 weeks The ADCS-iADL is a 17-item subset of the Alzheimer's Disease Cooperative Study -Activities of Daily Living scale- an observer reported outcome that asks caregivers to rate the degree to which their family member or loved one can perform a variety of tasks. The scoring range is from 0 to 59 with higher scores indicated better performance.
Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC). 24 weeks The ADCS-CGIC is a clinician reported outcome that utilizes a systematic method for assessing clinically meaningful change taking input from both the participant and the informed other into account. The scale rates total change on a 7 point scale:
1. = Very much improved
2. = Much improved
3. = Minimally improved
4. = No change
5. = Minimally worse
6. = Much worse
7. = Very much worse
Trial Locations
- Locations (5)
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
USF Health Byrd Alzheimer's Institute
🇺🇸Tampa, Florida, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Riverside Neurology Specialists
🇺🇸Hampton, Virginia, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton🇺🇸Boca Raton, Florida, United States