Memesto Wearable Repetitive Message and Music Therapy Device Music Therapy Device That Senses and Reduces Agitation in People With AD,

NCT ID: NCT06596278

Last Updated: 2024-09-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-12-31

Brief Summary

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This is a 12-week proof-of-concept study to evaluate the efficacy of Memesto in reducing agitation in persons with Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) currently living in a residential care facility. It is hypothesized that Memesto use will result in a reduction in agitation.

Detailed Description

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After informed consent is obtained and preliminary eligibility established, participants will be trained and issued the Memesto device for use over a 2-week screening/training phase. Participants successfully completing this phase will proceed into a 10-week open label treatment phase (via telephone and/or in-person data collection).

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Stage 1
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Memesto Intervention

Memesto device intervention

Group Type EXPERIMENTAL

Memesto

Intervention Type DEVICE

Memesto wearable audio player

Interventions

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Memesto

Memesto wearable audio player

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role collaborator

Edgewater Safety Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Jeffery T. Banker

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raj C. Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush Alzheimer's Disease Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ESS-MEM-001

Identifier Type: -

Identifier Source: org_study_id

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