Dementia Clinical Trial
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Birkeland Current | Waco | Texas |
Lead Sponsor | Collaborator |
---|---|
National Institute on Aging (NIA) | Baylor Research Institute, Georgia Institute of Technology, Texas A&M University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 18 months | |
Primary | 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. | 18 months | |
Secondary | 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. | 18 months |
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