DementiaNCT04871698
On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs
An observational study of Dementia and Dementia Alzheimers, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this research is to compare the effectiveness of a continuous monitoring system to assess Activities of Daily Living (ADLs) over time compared to the traditional assessments used by medical professionals as Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) progresses. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Dementia Alzheimers
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 31 Mar 2022
- How long will I take part?
- 18 Months
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults 65 and older with mild to moderate dementia.
Who may be able to join
- Fluent in English to understand and sign the consent or assent documents.
- Adult over 65 years of age with no children under 18 years old living in residence.
- Adult anticipates they will be living primarily at designated residence over next 18 months.
- Must receive caregiver interaction at least 6 hours/week.
- Must undergo a Mini-Mental State Exam (MMSE) assessment at baseline during recruitment as well as at the end of the study with a resulting score of 11-25 as part of the recruitment phase of the study.
- Must be willing to have home or facility equipped with sensors to obtain activity and location data.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Birkeland Current
Waco, Texas, 76704
Melissa SoRelle, 254-742-6030, melissa.sorelle@birkelandcurrent.com
Sarah Fitch, 254-742-6034, sarah.fitch@birkelandcurrent.com
About this study
Official title: Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System
The purpose of this research is to compare the effectiveness of a continuous monitoring system to assess Activities of Daily Living (ADLs) over time compared to the traditional assessments used by medical professionals as Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) progresses.
- Conditions
- Dementia, Dementia Alzheimers
- Medical subject headings
- Dementia, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment
The ADCS-ADL/23 assessment will be utilized to measure changes in activities of daily living in the sample population while BC's system is also in place independently measuring the changes in activities of daily living.
Measured: 18 months
Identify improved sensitivities for detection of early and moderate-stage AD/ADRD activities of daily living changes
AI techniques will search sensor data for subfactor and novel groupings for statistically significant improvements from what is measured by the ADCS/ADL-23 assessment of decline.
Measured: 18 months
Secondary outcomes (1)
Establish initial data sets and protocols for use of the developed ADL/IADL system data for integration with AD/ADRD research
Database structures and meta-data will be established for anonymous data sets.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start14 Sep 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Texas A&M University, Baylor Research Institute, Georgia Institute of Technology
- Responsible party
- Principal investigator, John Fitch, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871698
- Sponsor's protocol ID
- R44AG065118
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 4 May 2021
- 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System
- ClinicalTrials.gov ID
- NCT04871698
- Acronym / sponsor ID
- R44AG065118
- Conditions
- Dementia, Dementia Alzheimers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Texas A&M University, Baylor Research Institute, Georgia Institute of Technology
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 4 May 2021 (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 research is to compare the effectiveness of a continuous monitoring system to assess Activities of Daily Living (ADLs) over time compared to the traditional assessments used by medical professionals as Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) progresses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults 65 and older with mild to moderate dementia.
Key inclusion criteria (6 listed)
- Fluent in English to understand and sign the consent or assent documents.
- Adult over 65 years of age with no children under 18 years old living in residence.
- Adult anticipates they will be living primarily at designated residence over next 18 months.
- Must receive caregiver interaction at least 6 hours/week.
- Must undergo a Mini-Mental State Exam (MMSE) assessment at baseline during recruitment as well as at the end of the study with a resulting score of 11-25 as part of the recruitment phase of the study.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment
Time frame: 18 months
The ADCS-ADL/23 assessment will be utilized to measure changes in activities of daily living in the sample population while BC's system is also in place independently measuring the changes in activities of daily living.
Identify improved sensitivities for detection of early and moderate-stage AD/ADRD activities of daily living changes
Time frame: 18 months
AI techniques will search sensor data for subfactor and novel groupings for statistically significant improvements from what is measured by the ADCS/ADL-23 assessment of decline.
1 secondary outcome
Establish initial data sets and protocols for use of the developed ADL/IADL system data for integration with AD/ADRD research
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Dementia Alzheimers, run by National Institute on Aging (NIA) 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 6 inclusion and 1 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 4 May 2021. 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 Melissa SoRelle (254-742-6030, melissa.sorelle@birkelandcurrent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment (time frame: 18 months). The study lists 2 primary outcomes in all. 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 4 May 2021.