Clinical trial NCT05153161: Memesto Wearable Device for Persons With Dementia
Official title: Development of Memesto Wearable Repetitive Message/Music Therapy Device That Senses and Reduces Agitation in Alzheimer's Disease and Alzheimer's Disease Related Dementia (AD/ADRD) Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
ADRD
dementia
memory care
agitation
non-pharmacological intervention
medical device
SBIR
repetitive message therapy
Lead sponsor: Edgewater Safety Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
First posted: 2021-12-10
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a proven protocol to test a pharmacological treatment of agitation in AD/ADRD persons using individuals in nursing homes and assisted care settings
Primary purpose: TREATMENT

Brief summary: An estimated 70% of the 7.2+ million people in the U.S. with Alzheimer's Disease and Alzheimer's Disease-Related Dementias experience agitation, characterized by poorly organized and purposeless psychomotor activity that diminishes their quality of life. The goal of this Small Business Innovation Research (SBIR) project is to develop a wearable therapy device that automatically senses rising agitation, and alerts caregivers while deploying calming voice and music therapy to help them avoid crisis level behavior. This device will improve health outcomes for AD/ADRD sufferers and reduce the substantial stress suffered by their caregivers.

Detailed description: Edgewater Safety Systems developed a smart wearable media player (Memesto) that family and other caregivers could use with a web app to record, schedule and deliver voice and music to an ADRD patient through this device. Caregivers were able to record greetings, reminders to take medication, drink water or eat lunch, and these messages could be played for the patient via the device at set dates and times. In a follow-up survey with caregivers who used the Memesto with patients at care facilities, 11 of 11 rated it 4.5 out of 5 for "usefulness in mitigating agitation." Edgewater proposes to develop a more innovative wearable device that senses rising agitation in the patient and automatically plays therapeutic messages and music shown to have had the greatest success reducing or eliminating agitation in the wearer's previous episodes. With this next generation Memesto, Edgewater aims to improve quality of life for a diverse population of ADRD persons; diminish the use of potentially harmful drugs as an intervention; and help reduce stress and burnout in caregivers. The new Memesto will have four key elements of innovation: 1) repetitive, programmable voice and music therapy in a wearable device, a first for AD/ADRD care; 2) web-based app that enables family and friends to deliver personal messages and music anytime; 3) agitation-sensing system that reads biometric data from non-invasive body-worn sensors to automatically deploy media therapy; and 4) sensor data taken at start and end of the played media to determine effectiveness of that media in reducing agitation and continually prioritize the most effective media.In the Phase I study, Edgewater will partner with Rush Alzheimer's Disease Center to: 1) carry out a 10-week clinical trial on 20 ADRD persons to gather quantitative evidence of the original audio player's effectiveness at reducing agitation; and 2) demonstrate feasibility of ADRD agitation detection and automated intervention. Phase II will focus on complete implementation of a fully automated, miniaturized, wearable Memesto device and a broad field trial testing efficacy of the new agitation sensing and automated intervention system.

Eligibility criteria: Inclusion 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.13 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 residential living facility.

Exclusion Criteria:

* Persons could screen fail if the device cannot be utilized by the person living with AD/ADRD, family caregiver, or professional caregiver.

Primary outcomes:
measure: Change from Baseline to Week 10 in average Neuropsychiatric Inventory (NPI) agitation domain score
timeFrame: 10 weeks
Secondary outcomes:
measure: Change from Baseline to Week 10 in average Clinical Global Impression - Severity (CGI-S) score
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Edgewater Safety Systems, LLC
name: Jeffery T. Banker, MS
role: PRINCIPAL_INVESTIGATOR
References: