On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

Dementia Clinical Trial

Official title:

Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871698
• Other study ID #: R44AG065118
• Status: Recruiting
• Start date: September 14, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2021
• Source: National Institute on Aging (NIA)
• Contact: Melissa SoRelle
• Phone: 254-742-6030
• Email: melissa.sorelle[@]birkelandcurrent.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• 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: -

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia Alzheimers

Locations

Country	Name	City	State
United States	Birkeland Current	Waco	Texas

Sponsors (4)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	Baylor Research Institute, Georgia Institute of Technology, Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

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