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WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease | Clinical Trials | Clareo Health

WITHDRAWNNA

WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

NCT05032482•Scion NeuroStim

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

Age

65 - 85 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (5)

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

Riverside Neurology Specialists

Hampton, Virginia, United States

Key Dates

Start Date

December 1, 2023

Primary Completion Date

March 1, 2024

Completion Date

March 1, 2024

Last Updated

May 13, 2024

Conditions

Mild Alzheimer's Disease

Interventions

Non-invasive brainstem stimulation

DEVICE

Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease

NCT05417555

Mild Cognitive ImpairmentAmnestic Mild Cognitive Disorder+2 more

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RECRUITING

Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study

NCT06058234

Mild Alzheimer's DiseaseMild Cognitive Impairment (MCI) Due to Alzheimer's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease

Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease

Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease