On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04871698

Enrollment

140

Registered

2021-05-04

Start date

2020-09-14

Completion date

2022-03-31

Last updated

2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Dementia Alzheimers

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment	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	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.

Secondary

Measure	Time frame	Description
Establish initial data sets and protocols for use of the developed ADL/IADL system data for integration with AD/ADRD research	18 months	Database structures and meta-data will be established for anonymous data sets.

Countries

United States

Contacts

Primary ContactMelissa SoRelle

melissa.sorelle@birkelandcurrent.com254-742-6030

Backup ContactSarah Fitch, MA

sarah.fitch@birkelandcurrent.com254-742-6034

Outcome results