Cognitive Decline, Mild0150-24 SORNCT07596186
Predict Early Cognitive Changes in a Healthy Elderly Population by Passively Recording Sensor Data From Mobile Devices
An observational study of Cognitive Decline, Mild, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Mild
- How many people
- 98 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2024to 1 Jan 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Tenants in assisted living housing
Who may be able to join
- Age 65 and over
- Clalit HMO members.
- Without a known diagnosis of dementia
- Uses Android mobile phones and writes text messages
Who cannot join
- A known diagnosis of dementia
- Uses IOS mobile.
- Doesn't write text messages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cognitive Decline, Mild
- Keywords
- Early Dementia, Mild Cognitive Decline
- Medical subject headings
- Cognitive Dysfunction, Lymphoma, Follicular, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction model of mobile device data, collected for 9 months of lower scores in Neurotrax cognitive assessment compared to baseline evaluation.
Mobile device sensor data
Measured: Baseline and 9 Month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Dec 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Decline, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gal Ifergane MD, Soroka University Medical Center
- Investigators
- Gal Ifergane, MD-MHA, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596186
- Sponsor's protocol ID
- 0150-24 SOR
- Other IDs
- Applebaum
- Acronym
- 0150-24 SOR
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Digital Monitoring for the Detection of Cognitive Decline How Patterns of Behavior May Predict Dementia and Alzheimer's
- ClinicalTrials.gov ID
- NCT07596186
- Acronym / sponsor ID
- 0150-24 SOR / 0150-24 SOR
- Conditions
- Cognitive Decline, Mild
- Keywords
- Early Dementia, Mild Cognitive Decline
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Tenants in assisted living housing
Key inclusion criteria (4 listed)
- Age 65 and over
- Clalit HMO members.
- Without a known diagnosis of dementia
- Uses Android mobile phones and writes text messages
Key exclusion criteria (3 listed)
- A known diagnosis of dementia
- Uses IOS mobile.
- Doesn't write text messages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gal Ifergane, MD-MHA principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline, Mild, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.