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NCT05153161

Memesto Wearable Device for Persons With Dementia

Completed Phase 1 Last updated 3 January 2024
What this trial tests

Phase 1 trial testing Memesto in Alzheimer Disease in 9 participants. Completed in 30 November 2023.

Timeline
31 August 2022
Primary endpoint
30 November 2023
30 November 2023

Quick facts

Lead sponsorEdgewater Safety Systems, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date31 August 2022
Primary completion30 November 2023
Estimated completion30 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Edgewater Safety Systems, Inc.

Who can join

Eligibility, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An estimated 70% of the 7.2+ million people in the U.S. with Alzheimer's Disease and Alzheimer's Disease-Related Dementias experience agitation, characterized by poorly organized and purposeless psychomotor activity that diminishes their quality of life. The goal of this Small Business Innovation Research (SBIR) project is to develop a wearable therapy device that automatically senses rising agitation, and alerts caregivers while deploying calming voice and music therapy to help them avoid crisis level behavior. This device will improve health outcomes for AD/ADRD sufferers and reduce the substantial stress suffered by their caregivers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Does an Audio Wearable Lead to Agitation Reduction in Dementia: The Memesto AWARD Proof-of-Principle Clinical Research Study
    Shah R, Basapur S, Hendrickson K, Anderson J, et al · · 2025 · DOI 10.21203/rs.3.rs-6008628/v1

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Other trials of Memesto

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other Edgewater Safety Systems, Inc. trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing