Alzheimer's DiseaseAWARDNCT06596278
Memesto Wearable Repetitive Message and Music Therapy Device Music Therapy Device That Senses and Reduces Agitation in People With AD,
A study testing Memesto in people with Alzheimer's Disease, run by Edgewater Safety Systems, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Memesto
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country.
United States1 site
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612
About this study
Official title: Development of Memesto, a Wearable Repetitive Message and Music Therapy Device That Senses and Reduces Agitation in Persons With AD/ADRD
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.
Read the detailed description
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).
- Conditions
- Alzheimer's Disease
- Being tested
- Memesto
- Keywords
- dementia, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemestoDevice
Memesto wearable audio player
| Study group | Role | What they receive |
|---|---|---|
| Memesto Intervention | Experimental | Memesto device intervention Receives: Device: Memesto |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2022
- Primary completion21 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Stage 1
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgewater Safety Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Responsible party
- Principal investigator, Jeffery T. Banker, Edgewater Safety Systems, Inc.
- Investigators
- Raj C. Shah, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596278
- Sponsor's protocol ID
- ESS-MEM-001
- Acronym
- AWARD
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Memesto, a Wearable Repetitive Message and Music Therapy Device That Senses and Reduces Agitation in Persons With AD/ADRD
- ClinicalTrials.gov ID
- NCT06596278
- Acronym / sponsor ID
- AWARD / ESS-MEM-001
- Conditions
- Alzheimer's Disease
- Keywords
- dementia, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Edgewater Safety Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stage 1
| Arm | Type | Receives |
|---|---|---|
| Memesto Intervention | Experimental | Device: MemestoMemesto device intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemestoMemesto wearable audio player | Device | Memesto Intervention |
Primary outcome
Average score on the Neuropsychiatric Inventory (NPI) agitation domain
Time frame: 10 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj C. Shah, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memesto in people with Alzheimer's Disease, run by Edgewater Safety Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average score on the Neuropsychiatric Inventory (NPI) agitation domain (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.