WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease (WAVE-AD)

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).

Study Overview

• Status: Withdrawn
• Conditions: Mild Alzheimer's Disease
• Intervention / Treatment: Device: Non-invasive brainstem stimulation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Tampa, Florida, United States, 33613
      • USF Health Byrd Alzheimer's Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Riverside Neurology Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Investigational Treatment 1; Investigational treatment mode (stimulation pattern) 1	Device: Non-invasive brainstem stimulation; 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.
Other: Investigational Treatment 2; Investigational treatment mode (stimulation pattern) 2	Device: Non-invasive brainstem stimulation; 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.
Other: Investigational Treatment Mode - Open Label; Investigational treatment mode (stimulation pattern)	Device: Non-invasive brainstem stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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: = Very much improved; = Much improved; = Minimally improved; = No change; = Minimally worse; = Much worse; = Very much worse	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in The NeuroPsychiatric Inventory.	a brief interview administered to caregivers to evaluate behavioral disturbances in dementia patients	24 weeks and 48 weeks
Change from baseline in The Zarit Burden Interview.	a measure of caregiver burden completed by caregivers	24 weeks and 48 weeks
Change from baseline in The Mini- Mental State Exam.	a widely used test of cognitive function among the elderly.	24 weeks and 48 weeks
Change from baseline in the Alzheimer's Disease Cooperative Study -Activities of Daily Living.	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.	24 weeks and 48 weeks
Change from baseline in the Symbol Digit Modality Test.	a brief and commonly used test to evaluate processing speed.	24 weeks and 48 weeks
Change from baseline in Phonemic Verbal Fluency Test.	a brief measure of verbal functioning.	24 weeks and 48 weeks
Change from baseline in the bloodborne biomarkers of neurodegeneration and blood-brain barrier permeability	a biomarker for neurodegeneration	24 weeks and 48 weeks
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.	48 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.	48 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: = Very much improved; = Much improved; = Minimally improved; = No change; = Minimally worse; = Much worse; = Very much worse	48 weeks

Collaborators and Investigators

• Sponsor: Scion NeuroStim

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Non-Invasive Brain Stimulation; Brainstem; Open Label Extension; Medical Devices
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: SNS-AD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No