Clinical trial NCT05032482: WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
Official title: WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mild Alzheimer's Disease
Keywords: Open Label Extension
Medical Devices
Non-Invasive Brain Stimulation
Randomized Controlled Trial
Brainstem
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL).
timeFrame: 24 weeks
measure: Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
timeFrame: 24 weeks
Other outcomes:
measure: Change from baseline in The NeuroPsychiatric Inventory.
timeFrame: 24 weeks and 48 weeks
measure: Change from baseline in The Zarit Burden Interview.
timeFrame: 24 weeks and 48 weeks
measure: Change from baseline in The Mini- Mental State Exam.
timeFrame: 24 weeks and 48 weeks
measure: Change from baseline in the Alzheimer's Disease Cooperative Study -Activities of Daily Living.
timeFrame: 24 weeks and 48 weeks
measure: Change from baseline in the Symbol Digit Modality Test.
timeFrame: 24 weeks and 48 weeks
measure: Change from baseline in Phonemic Verbal Fluency Test.
timeFrame: 24 weeks and 48 weeks
measure: Change from baseline in the bloodborne biomarkers of neurodegeneration and blood-brain barrier permeability
timeFrame: 24 weeks and 48 weeks
measure: Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14).
timeFrame: 48 weeks
measure: Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL).
timeFrame: 48 weeks
measure: Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
timeFrame: 48 weeks
Locations:
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Tampa
country: United States
facility: USF Health Byrd Alzheimer's Institute
state: Florida
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Hampton
country: United States
facility: Riverside Neurology Specialists
state: Virginia
Study officials:
References: