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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Study participants will self-administer \~19-minute treatments twice daily in the home setting over 24 weeks using a non-invasive brainstem modulation device. All participants will use the same treatment mode during the open label extension.
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
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)
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.
Time frame: 24 weeks
Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL).
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.
Time frame: 24 weeks
Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
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
Time frame: 24 weeks
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Riverside Neurology Specialists
Hampton, Virginia, United States