WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Study Overview
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Brief Summary
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This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).

Detailed Description
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Up to 45 participants will first enter the double-blinded, controlled, randomized clinical trial (RCT) and will self-administer treatments twice daily in the home setting over a period of 24 weeks. Then participants who completed the RCT portion of the study will enter the Open Label Extension (OLE) where all participants will self-administer twice-daily treatments using a treatment mode that previously was shown to be associated with improved cognition in another neurodegenerative disorder. The OLE treatment period will last 24 weeks.

Official Title
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WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Device: Investigational Treatment Mode (Stimulation Pattern)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants (aged 65 - 85 years inclusive) diagnosed with mild, late onset Alzheimer's disease (AD). Participants must be fully vaccinated against COVID-19. Participants must be willing and able to comply with all study requirements. Participants and investigators must expect that the participant will be able to remain on a stable regimen used for the management of AD. Participant must have a study partner that is willing to participate in the trial. The study partner must be someone that sees the subject for more than three hours a day, 5x per week) that is fully vaccinated against COVID-19. Exclusion Criteria: Has experienced a heart attack, angina, or stroke within the past 12 months. Are being treated with another neurostimulation device. Experience frequent falls (defined by 2 or more falls in the past month). 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, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination performed by medically qualified Investigators. Have a recent history of frequent ear infections (≥ 1 per year over the past two years). Have a cochlear implant or hearing aids that cannot be easily/reliably removed for treatment. Have chronic (>3 months) 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Investigational Treatment 1<br>Study participants will self-administer  19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. | Device: Investigational Treatment Mode (Stimulation Pattern)<br>* Study participants will self-administer  19-minute treatments twice daily in the home setting using non-invasive brainstem modulation device.<br>|
| Other: Investigational Treatment 2<br>Study participants will self-administer  19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. | Device: Investigational Treatment Mode (Stimulation Pattern)<br>* Study participants will self-administer  19-minute treatments twice daily in the home setting using non-invasive brainstem modulation device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14) | Compare differences in change scores between the end of treatment visit and the baseline across the two treatment groups. The Alzheimer's Disease Assessment Scale - Cognitive Plus (ADAS-Cog14) scale ranges from 0 to 90. Higher scores indicate greater disease severity. | 24 weeks |