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Behavioural Intervention

Memesto Wearable Device for Dementia

Phase 1

Waitlist Available

Led By Jeffery T. Banker, MS

Research Sponsored by Edgewater Safety Systems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.13 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 residential living facility.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

Study Summary

This trial will develop a wearable device to reduce agitation in Alzheimer's and dementia patients, alerting caregivers and using calming music to help avoid crises.

Who is the study for?

This trial is for adults with dementia, specifically those who show severe agitation that might need medication. They must have a caregiver willing to participate and be from a residential living facility.Check my eligibility

What is being tested?

The Memesto wearable device is being tested. It's designed to detect when someone with dementia gets agitated and then uses voice or music therapy to calm them down, helping both the patient and their caregivers.See study design

What are the potential side effects?

Since this trial involves a non-drug intervention (wearable device), traditional side effects like you'd see with medications are not expected. However, there may be discomfort or skin irritation from wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline to Week 10 in average Neuropsychiatric Inventory (NPI) agitation domain score

Secondary outcome measures

Change from Baseline to Week 10 in average Clinical Global Impression - Severity (CGI-S) score

Trial Design

1Treatment groups

Experimental Treatment

Group I: Persons with ADRD living in a residential care facilityExperimental Treatment1 Intervention

Each consented participant will receive the current Memesto device and will be provided formal and informal training instructions. After consent and screening, a two-week training period with a Memesto device will be followed by ten weeks of data collection. An experienced research assistant will administer the baseline NPI in order to collect the agitation ratings by the family caregiver, and the professional caregiver will be collected by a trained research assistant and captured in an electronic case report form designed using REDCap.14,15 Then, participants will undergo evaluation of the NPI agitation domain at 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 10 weeks. Adverse events related to the device will be collected from the family and professional caregivers. Human centered system designers will work with the operations team to enhance participant engagement and maintain high quality data collection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Memesto

2022

Completed Phase 1

~10

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edgewater Safety Systems, Inc.Lead Sponsor

Rush University Medical CenterOTHER

422 Previous Clinical Trials

163,522 Total Patients Enrolled

Jeffery T. Banker, MSPrincipal InvestigatorEdgewater Safety Systems, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can participate in this experiment?

"Indeed, the most recent data uploaded to clinicaltrials.gov confirms that this healthcare study is actively recruiting patients. It was first posted on August 31st 2022 and has recruited 20 participants from one medical centre since then."

Answered by AI

Are new participants able to enroll in this investigation?

"Affirmative. According to information posted on clinicaltrials.gov, this medical experiment commenced recruitment on August 31st 2022 and was last updated November 10th 2023. This trial is seeking a cohort of 20 individuals at one particular site."

Answered by AI

Does the Food and Drug Administration sanction residential care for Persons with Alzheimer's Disease and Related Disorders?

"Given the limited data on safety and efficacy, our team at Power estimates the risk of Persons with ADRD living in a residential care facility to be low (rating 1)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Memesto Wearable Device for Persons With Dementia

2022. "Memesto Wearable Device for Persons With Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153161.