NCT07120347

Brief Summary

The investigators aim to use smart-home sensors and artificial intelligence (AI) to monitor and detect Alzheimer's Disease and Related Dementias (ADRD)-specific daily activities among older adults, with the goal of early symptom detection and personalized support. Dementia, which impacts memory and cognition, remains a global concern. In the United States, more than 6.7 million individuals aged 65 and older are living with ADRD, and projected annual healthcare costs are expected to reach $1 trillion by 2050. This underscores the need for deeper understanding and innovative support. To address the unique challenges associated with ADRD, such as cognitive decline, personalized strategies that promote independent well-being are essential. Smart-home sensors can support older adults with ADRD as they continue to live in their homes. These sensors provide real-time data on health and daily activities, offering insights into their daily lives. However, adoption of these technologies is low, and the practical application of AI remains limited. This highlights the need for further research to make these devices more accessible to this population. The investigators' aims include: Conducting focus groups with individuals with and without ADRD and their caregivers to identify daily activities that can be measured using in-home sensors; Collecting in-home sensor data from older adults with and without ADRD; and Using AI to develop a tool for recognizing daily activities. The integration of smart-home sensors with advanced data-analysis techniques holds significant potential for transforming the support and care provided to individuals with ADRD. Ultimately, the investigators' findings will contribute to improving the quality of life for affected individuals and alleviating the burden on caregivers and healthcare systems.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Aug 2024Jul 2027

Study Start

First participant enrolled

August 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

August 13, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

May 22, 2025

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Classification accuracy of ambient sensor-based daily activity models

    Percent of daily activity labels correctly predicted by SVM, XGBoost, LSTM and Transformer models, trained and tested on ambient motion and environmental sensor data collected during weeks 1-4 from participants with and without early-stage ADRD.

    Weeks 1-4 after enrollment

  • F1 score of ambient sensor-based daily activity models

    Harmonic mean of precision and recall for SVM, XGBoost, LSTM and Transformer models, evaluated on held-out portions of the week 1-4 ambient sensor data.

    Weeks 1-4 after enrollment

  • Area under the ROC curve of ambient sensor-based daily activity models

    AUC of ROC curves for SVM, XGBoost, LSTM and Transformer models distinguishing among daily activity classes, based on training and testing using weeks 1-4 ambient sensor readings.

    Weeks 1-4 after enrollment

Study Arms (2)

Pariticpants w/ ADRD

EXPERIMENTAL
Other: Remote Ambient Sensor System

Participants w/o ADRD

ACTIVE COMPARATOR
Other: Remote Ambient Sensor System

Interventions

Remote sensors (motion, door contact) deployed in participants' home connected through raspberry pi and mobile hotspot

Pariticpants w/ ADRDParticipants w/o ADRD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling, English-speaking adults aged ≥ 50 years
  • Clinical diagnosis of mild cognitive impairment or mild dementia (ADRD)
  • Diagnosis established by a neuropsychologist, neurologist, or geriatrician within the University of Missouri Healthcare System
  • Diagnosis confirmed using the latest consensus criteria and verified through record review
  • No restriction on the etiology of the cognitive disorder (e.g., Alzheimer's disease, vascular dementia, mixed dementia)

You may not qualify if:

  • Clinical Dementia Rating (CDR) global score \> 1 (moderate or severe dementia)
  • Cognitive or functional impairments that would preclude meaningful participation in daily activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Central Study Contacts

Knoo Lee, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: While all participants is applied with sensor system, they are divided into two groups by condition (participants w/ and w/o ADRD)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ast Professor

Study Record Dates

First Submitted

May 22, 2025

First Posted

August 13, 2025

Study Start

August 1, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

August 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations