Memesto Wearable Device for Persons With Dementia

NCT05153161 | Completed Phase 1 DMC

• 1 other identifier: 1R43AG074725-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; ADRD; dementia; memory care; agitation; non-pharmacological intervention; medical device; SBIR; repetitive message therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 10 in average Neuropsychiatric Inventory (NPI) agitation domain score

  The NPI agitation domain score is a composite score (symptom frequency x severity) ranging from 1 to 12; a higher score represents greater distress.

  10 weeks

Secondary Outcomes (1)

• Change from Baseline to Week 10 in average Clinical Global Impression - Severity (CGI-S) score

  10 weeks

Study Arms (1)

Persons with ADRD living in a residential care facility

EXPERIMENTAL

Each consented participant will receive the current Memesto device and will be provided formal and informal training instructions. After consent and screening, a two-week training period with a Memesto device will be followed by ten weeks of data collection. An experienced research assistant will administer the baseline NPI in order to collect the agitation ratings by the family caregiver, and the professional caregiver will be collected by a trained research assistant and captured in an electronic case report form designed using REDCap.14,15 Then, participants will undergo evaluation of the NPI agitation domain at 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 10 weeks. Adverse events related to the device will be collected from the family and professional caregivers. Human centered system designers will work with the operations team to enhance participant engagement and maintain high quality data collection.

Device: Memesto

Interventions

Memesto DEVICE

Edgewater plans to develop the next generation Memesto, a wearable device able to sense increasing agitation in ADRD sufferers and automatically deliver agitation-reducing personalized voice messages and music most effective at calming the individual based on past interventions. This innovative product will be the first wearable ADRD device to track agitation via body-worn sensors and automatically deploy agitation-reducing voice and music therapy without any caregiver interaction. The new system will use analytics to track the effectiveness of the various media and update the calming 'play list' over time.

Persons with ADRD living in a residential care facility

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Edgewater Safety Systems, Inc.: lead
• Rush University Medical Center: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Shah R, Basapur S, Hendrickson K, Anderson J, Plenge J, Troutman A, Ranjit E, Banker J. Does an Audio Wearable Lead to Agitation Reduction in Dementia: The Memesto AWARD Proof-of-Principle Clinical Research Study. Res Sq [Preprint]. 2025 Feb 17:rs.3.rs-6008628. doi: 10.21203/rs.3.rs-6008628/v1.

  PMID: 40034447 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Jeffery T. Banker, MS

  Edgewater Safety Systems, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a proven protocol to test a pharmacological treatment of agitation in AD/ADRD persons using individuals in nursing homes and assisted care settings

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 10, 2021
• Study Start: August 31, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

US (1)