An interventional study of Memesto in Alzheimer's Disease, sponsored by Edgewater Safety Systems, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Edgewater Safety Systems, Inc. · Not applicable, Interventional, and Device feasibility
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.
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).
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 9 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Edgewater Safety Systems, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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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Memesto device intervention
Device: Memesto
Memesto wearable audio player
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
Time frame: 10 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data will be made available on the Rush Alzheimer's Disease Center Research Resource Sharing Hub, which has descriptions of the studies and variables. It has a dynamic query function to aid searches for data. 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.
Supporting information: Study protocol, Icf
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Edgewater Safety Systems, Inc.