Clinical trial NCT06596278: Memesto Wearable Repetitive Message and Music Therapy Device Music Therapy Device That Senses and Reduces Agitation in People With AD,
Official title: Development of Memesto, a Wearable Repetitive Message and Music Therapy Device That Senses and Reduces Agitation in Persons With AD/ADRD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: dementia
Alzheimer's disease
Lead sponsor: Edgewater Safety Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
First posted: 2024-09-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Stage 1
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed description: 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).

Eligibility criteria: 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.

-

Primary outcomes:
measure: Average score on the Neuropsychiatric Inventory (NPI) agitation domain
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Raj C. Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: