WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Mild Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The first 24 weeks will be the randomized controlled portion of the study; the remaining 24 weeks will be an open label extension.

Study Groups

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Investigational Treatment 1

Investigational treatment mode (stimulation pattern) 1

Group Type OTHER

Non-invasive brainstem stimulation

Intervention Type DEVICE

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.

Investigational Treatment 2

Investigational treatment mode (stimulation pattern) 2

Group Type OTHER

Non-invasive brainstem stimulation

Intervention Type DEVICE

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.

Investigational Treatment Mode - Open Label

Investigational treatment mode (stimulation pattern)

Group Type OTHER

Non-invasive brainstem stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No