Evidence map›Paper›PMID 40034447›Full record

ArticleResearch square2025

Does an Audio Wearable Lead to Agitation Reduction in Dementia: The Memesto AWARD Proof-of-Principle Clinical Research Study.

Raj Shah, Santosh Basapur, Kirsten Hendrickson, Julie Anderson, Jamie Plenge, Amelia Troutman, Eukesh Ranjit, Jeff Banker

Registry-linked trialAbstract readPreprint
In one paragraph

Article in Research square, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05153161 (Development of Memesto Wearable Repetitive Message/Music Therapy Device That Senses and Reduces Agitation in Alzheimer's Disease and Alzheimer's Disease Related Dementia), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05153161 phase1completednot on this map

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

TypeinterventionalSponsorEdgewater Safety Systems, Inc.Ran2022 to 2023Enrolled9ConditionsAlzheimer DiseaseArmsMemesto
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Raj ShahRush University Medical Center.
Santosh BasapurRush University Medical Center.
Kirsten HendricksonRush University Medical Center.
Julie AndersonEdgewater Safety Systems, Inc.
Jamie PlengeRush University Medical Center.
Amelia TroutmanRush University Medical Center.
Eukesh RanjitSouthern Illinois University School of Medicine.
Jeff BankerEdgewater Safety Systems, Inc.

Funding

Development of Memesto, a wearable repetitive message and music therapy device that senses and reduces agitation in persons with AD/ADRD.R43AG074725 · NIA · EDGEWATER SAFETY SYSTEMS LLC · PI BANKER, JEFFERY · 2021 to 2021
$500k
NIA NIH HHS R43 AG074725
6 · The paper itself

Abstract

Background: Agitation is a common behavioral symptom in persons living with Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD), especially in the setting of residential care. Pharmacologic and non-pharmacologic interventions are limited. Memesto is a wearable audio device designed to provide messages and music that can be scheduled or played on demand. The objective of this proof-of-principle study was to quantify whether Memesto can reduce agitation in persons with AD/ADRD. Methods: Persons living with AD/ADRD with a Clinical Global Impressions-Severity (CGI-S) average score of 4 or greater, one informal caregiver, and one formal caregiver (triad) were recruited from residential care facilities in the Midwest region of the United States. After consent and a two-week training period, the triad was monitored every two weeks from Baseline to Week 10 with the Neuropsychiatric Inventory (NPI) agitation domain subscale (primary endpoint) and the CGI-S scale (secondary endpoint) with the last observation carried forward. The average score on the NPI agitation domain subscale and the CGI-S scale at Baseline and Week 10 as rated by the two caregivers were compared. A 30% drop in the NPI agitation domain subscale in 50% of the persons living with AD/ADRD was considered a clinically meaningful finding. Results: Over thirteen months of recruitment, 9 triads were identified in 6 residential care facilities in three Midwestern states. For the NPI agitation domain, 6 of 9 (67%) persons with AD/ADRD had a 30% reduction in the average caregiver ratings at Week 10. No adverse events were identified associated with the use of the device. Device usability was rated as positive based on a survey. Discussion: This study provided quantitative data on psychometrically sound agitation scales regarding a 10-week treatment course with Memesto after a two-week training period. The results were limited by the inability to recruit the desired set of 20 triads due to disruptions in care and staff at residential care facilities. Further effectiveness testing in a larger cohort with a sham control device is necessary. Trial Registration: www.clinicaltrials.gov. NCT05153161. First posted December 10, 2021.

Indexed as

agitationAlzheimer’s Disease and Related Dementiasdeviceresidential care facilities

Identifiers

PMID40034447
PMCPMC11875299

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.