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OpenTrials
Completed

NCT Number: NCT06596278

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Given that people living with ADRD can be of any adult age, people meeting criteria for ADRD diagnosis will be regardless of age. Younger-onset people living with ADRD, which may be smaller, will be considered for participation along with adults older than age 65 that make up the largest portion of persons living with ADRD. The family and professional caregivers can be any age greater than eighteen. We anticipate that 5% of the People living with ADRD will be less than age 65 with 70% being greater than age 75 and 25% being between ages 65 and 74. For family caregivers, we envision most will be spouses with the same age distributions as the parents with a skew to a slightly younger age group for caregivers who are children of the person living with ADRD and/or the spouses of children. For professional caregivers, we anticipate they will be between the residential care workforce ages of 20 and 65 with a skew toward persons over age 40.

Inclusion/Exclusion Criteria: Eligible participants will be adults with a dementia diagnosis who have clinically significant agitation, defined as a state of poorly organized and purposeless psychomotor activity characterized by at least one of the following: aggressive verbal (screaming, cursing), aggressive physical (destroying objects, grabbing, fighting), or non-aggressive physical (restlessness, pacing) behaviors. The behavioral symptoms must be severe enough to warrant pharmacological treatment. A family caregiver must be willing to participate along with a professional caregiver from the resident living facility.

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Treatment and study plan

Memesto

Device

Memesto wearable audio player

Primary outcomes

  1. Average score on the Neuropsychiatric Inventory (NPI) agitation domain

    Time frame: 10 weeks

    The scores on the NPI agitation domain at baseline will be the comparator. A score of zero indicates no agitation is observed. If agitation is mentioned, caregivers will rate the agitation symptom frequency from 1 to 4 (less than once a week, about one time a week, several times a week, or more than once per day). Severity for each symptom is rated from 1 to 3 (mild, moderate, or marked). The NPI's composite (frequency x severity) score ranges from 1 to 12 for each positively endorsed domain.13 The average of the family and professional caregiver rating will be utilized

Sponsors and collaborators

Lead sponsor

Edgewater Safety Systems, Inc.

Industry

Collaborators

  • Rush University Medical Center

Registry information

Official study title

Development of Memesto, a Wearable Repetitive Message and Music Therapy Device That Senses and Reduces Agitation in Persons With AD/ADRD

Acronym: AWARD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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