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

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Investigational Treatment Mode (Stimulation Pattern)
Sponsored by
Scion NeuroStim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Investigational Treatment 1

    Investigational Treatment 2

    Arm Description

    Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device.

    Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2021
    Last Updated
    September 1, 2021
    Sponsor
    Scion NeuroStim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05032482
    Brief Title
    WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
    Acronym
    WAVE-AD
    Official Title
    WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Scion NeuroStim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The first 24 weeks will be the randomized controlled portion of the study the remaining 24 weeks will be an open label extension.
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Investigational Treatment 1
    Arm Type
    Other
    Arm Description
    Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device.
    Arm Title
    Investigational Treatment 2
    Arm Type
    Other
    Arm Description
    Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device.
    Intervention Type
    Device
    Intervention Name(s)
    Investigational Treatment Mode (Stimulation Pattern)
    Intervention Description
    Study participants will self-administer ~19-minute treatments twice daily in the home setting using non-invasive brainstem modulation device.
    Primary Outcome Measure Information:
    Title
    Change in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)
    Description
    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.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kara Richardson
    Phone
    984-884-1020
    Email
    krichardson@scionneurostim.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jemica Warren
    Email
    jwarren@scionneurostim.com

    12. IPD Sharing Statement

    Learn more about this trial

    WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

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