- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596186
Predict Early Cognitive Changes in a Healthy Elderly Population by Passively Recording Sensor Data From Mobile Devices (0150-24 SOR)
May 13, 2026 updated by: Gal Ifergane MD, Soroka University Medical Center
Passive Digital Monitoring for the Detection of Cognitive Decline How Patterns of Behavior May Predict Dementia and Alzheimer's
The study will recruit 100 participants aged 65+ residing in assisted living facilities.
Eligible participants will undergo an initial cognitive assessment to document their baseline cognitive status using cognitive tests conducted either in their assisted living facility or at Soroka Medical Center.
An app designed for research data collection (Aware-Light) will be installed on participants' mobile devices, collecting data only after participants provide consent.
Over three months, the app will automatically gather sensor data, including movement data from the accelerometer, orientation data from the gravity sensor, rotation data from the gyroscope, proximity data for measuring distance from nearby objects, ambient light levels from the light sensor, and typing dynamics such as typing frequency and duration without recording actual text.
The app will also track app usage, including activation, pauses, closures, background activity, notifications, and crashes, as well as air pressure through the barometer, phone capabilities through the telephony detector, and screen states such as on, locked, or off.
It will log communication events such as calls and messages without recording personal details, monitor vehicle speed through the linear accelerometer, track rotation angles through the rotation detector, and identify significant movements like walking, cycling, or traveling.
No typed data, such as passwords, will be collected.
After one month, the research team will contact participants to ensure the app functions correctly.
After three months, participants will undergo a second cognitive assessment, and the app will be uninstalled.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beersheba, Israel
- Soroka Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Tenants in assisted living housing
Description
Inclusion Criteria:
- Age 65 and over
- Clalit HMO members.
- Without a known diagnosis of dementia
- Uses Android mobile phones and writes text messages
Exclusion Criteria:
- A known diagnosis of dementia
- Uses IOS mobile.
- Doesn't write text messages
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction model of mobile device data, collected for 9 months of lower scores in Neurotrax cognitive assessment compared to baseline evaluation.
Time Frame: Baseline and 9 Month after
|
Mobile device sensor data
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Baseline and 9 Month after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gal Ifergane, MD-MHA, Soroka university medical center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
May 13, 2026
First Submitted That Met QC Criteria
May 13, 2026
First Posted (Actual)
May 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neurocognitive Disorders
- Cognition Disorders
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Hemic and Lymphatic Diseases
- Cognitive Dysfunction
- Lymphoma, Follicular
- Dementia
Other Study ID Numbers
- 0150-24 SOR
- Applebaum (Other Grant/Funding Number: Applebaum)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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