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

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.