DementiaNCT06140342
A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD)
An observational study of Dementia and Agitation, run by Autotune Me LLC at 1 site in United States.
Trial summary
The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Agitation, Depressive Symptoms
- What is being tested?
- Feasibility study of music-based mobile app
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Jan 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Older adults 65+.with dementia who demonstrates symptoms of dementia such as agitation or depressive symptoms. Caregiver of a person with dementia
Who may be able to join
- A person with ADRD exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.
- Stability with or without psychotropic or anti-depressant medications
- Ability to hear with or without an assistive device
- Family or close friend caregiver of persons with dementia
- Must be able to read and write in basic English
Who cannot join
- Inadequate hearing
- History of psychosis or other mental disorders other than depression
- Presence of substance or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Autotune Me, LLC
Brooklyn, New York, 11224
Kendra Ray, PhD, MPH, MBA, 347-636-7157
About this study
Official title: A Music-Based Mobile App to Combat Neuropsychiatric Symptoms in People Living With ADRD
The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.
- Conditions
- Dementia, Agitation, Depressive Symptoms
- Being tested
- Feasibility study of music-based mobile app
- Medical subject headings
- Dementia, Psychomotor Agitation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility study of music-based mobile appBehavioural
To determine the performance and usability of the app, 20 dyads will be recruited to test it for 2 weeks. The investigators will collect physiological measures based on the application's demonstration to auto-play music according to movement or sedentary states.
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of mobile app
Dyads of caregivers of people with dementia and their caregivers will wear a smartwatch and test the music-based mobile app for two weeks. The person with dementia will wear the smartwatch that will connect to the mobile app for 2 weeks. Caregivers will be asked to complete a daily checklist of their care recipients' behaviors for two weeks.
Participants will complete the Usefulness, Satisfaction and Ease of Use questionnaire that describes the usability of the mobile app. The minimum score is 30 while the maximum score is 240. The higher the score means the usability of the app is more acceptable.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start1 Aug 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autotune Me LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140342
- Sponsor's protocol ID
- 3-P30-AG-073105-02 SUPPLEMENT
- Other IDs
- 3P30AG073105-02
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Music-Based Mobile App to Combat Neuropsychiatric Symptoms in People Living With ADRD
- ClinicalTrials.gov ID
- NCT06140342
- Acronym / sponsor ID
- 3-P30-AG-073105-02 SUPPLEMENT
- Conditions
- Dementia, Agitation, Depressive Symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Autotune Me LLCUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Institute on Aging (NIA)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 Nov 2023 (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.
The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Older adults 65+.with dementia who demonstrates symptoms of dementia such as agitation or depressive symptoms. Caregiver of a person with dementia
Key inclusion criteria (5 listed)
- A person with ADRD exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.
- Stability with or without psychotropic or anti-depressant medications
- Ability to hear with or without an assistive device
- Family or close friend caregiver of persons with dementia
- Must be able to read and write in basic English
Key exclusion criteria (3 listed)
- Inadequate hearing
- History of psychosis or other mental disorders other than depression
- Presence of substance or alcohol abuse
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 |
|---|---|---|
| Feasibility study of music-based mobile appTo determine the performance and usability of the app, 20 dyads will be recruited to test it for 2 weeks. The investigators will collect physiological measures based on the application's demonstration to auto-play music according to movement or sedentary states. | Behavioural | – |
Primary outcome
Usability of mobile app
Time frame: 2 weeks
Dyads of caregivers of people with dementia and their caregivers will wear a smartwatch and test the music-based mobile app for two weeks. The person with dementia will wear the smartwatch that will connect to the mobile app for 2 weeks. Caregivers will be asked to complete a daily checklist of their care recipients' behaviors for two weeks. Participants will complete the Usefulness, Satisfaction and Ease of Use questionnaire that describes the usability of the mobile app. The minimum score is 30 while the maximum score is 240. The higher the score means the usability of the app is more acceptable.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Agitation, run by Autotune Me LLC 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?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kendra Ray, PhD, MBA, MPH (347-636-7157, kendra@autotuneme.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of mobile app (time frame: 2 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 24 Nov 2023.