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

NCT06596278 | Completed

• 1 other identifier: ESS-MEM-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

dementia; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Average score on the Neuropsychiatric Inventory (NPI) agitation domain

  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

  10 weeks

Study Arms (1)

Memesto Intervention

EXPERIMENTAL

Memesto device intervention

Device: Memesto

Interventions

Memesto DEVICE

Memesto wearable audio player

Memesto Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

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

Study Sites (1)

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Raj C. Shah, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: Stage 1

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2022
• Primary Completion: November 21, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Sharing of data is planned at the time of publication of the primary results or within 9 months of database lock, whichever comes first.
• Access Criteria: Researchers can set up a login account and then submit requests for data by following the instructions. Data Use Agreements are available for download. A request for data will be sent to Dr. Raj Shah (site PI for the study) via automated email alert that a request has been submitted. This initiates a web-based review process with regular and ad hoc reviewers to include a representative from Edgewater chosen based on required expertise. Upon approval and signature of a data use agreement, the data will be shared with the requestor. All requests, reviews, electronic discussions, and the final disposition of each request are archived.

Locations

US (1)