Mild Cognitive ImpairmentNCT06704971
Assessing Cognitive Decline at Home
An observational study of Mild Cognitive Impairment and Mild Dementia, run by Stanford University at 1 site in United States.
Trial summary
Neuropsychiatric symptoms (NPS) refer to a range of mental and emotional issues that can be observed through how patients move, perform daily tasks, and express feelings on their faces. In this study, the investigators want to find ways to accurately and unobtrusively track these symptoms in people's homes over time. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Dementia Alzheimers
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Dec 2026
- 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: Older Adults - 65+
Who may be able to join
- Age 65+ years old
- Any age and ethnicity.
- With or without, or at risk of mild to moderate dementia and healthy controls.
- Availability of a study partner (informant) who has contact with the patient at least once a week (this can also be the surrogate/LAR but does not necessarily have to be)
Who cannot join
- Those with severe mobility impairments
- participants in non-home settings (skilled nursing facilities, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Excellence Research Center
Palo Alto, California, 94304
About this study
Official title: Automatic Assessment of Neuropsychiatric Symptoms at Home Predictive of Mental Health and Cognitive Disorders Using Non-Intrusive Ambient Intelligence Technologies
Neuropsychiatric symptoms (NPS) refer to a range of mental and emotional issues that can be observed through how patients move, perform daily tasks, and express feelings on their faces. In this study, the investigators want to find ways to accurately and unobtrusively track these symptoms in people's homes over time. Our goals are to note when these symptoms happen, predict potential problems, and gather clear data to help doctors make accurate diagnoses.
To do this, the investigators will first collect information from participants who have in-home sensors. the investigators will then use special computer programs that can recognize everyday activities and identify features that connect to scores from the Mild Behavioral Impairment Checklist (MBI-C). These scores will be compared to a questionnaire (NPIQ) filled out by caregivers or family members, along with any relevant information from doctors about the patients' symptoms. The investigators aim to see how these features can help differentiate between types of NPS, such as mood changes and agitation.
Finally, the investigators will create a dashboard for doctors that summarizes the patterns of these symptoms in patients, making it easier to monitor and manage their mental health.
Read the detailed description
What the investigators would need from participants:
- Collect the participants' own data of daily activities from a room in participants home such as the participant's living room via a small camera the investigators provide for no less than 7 days and up to 30 days. The participant will have full control over the camera to turn on and off.
- The participant and a loved one will regularly answer short surveys asking about the participant's mood and daily functioning.
- At the end of agreed observation period, return the memory card of the participant's collected data from the camera in person or pre-paid FedEx envelope.
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Dementia Alzheimers, Dementia, Memory Impairment, NPS
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Memory Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
develop a personalized and clinically interpretable NPS assessment system
Assessing NPS relies primarily on clinician observation \& interviews with caregivers, usually within brief \& infrequent clinical visits. Precise assessment and monitoring methods would incorporate objective, patient- \& caregiver-friendly, real-time tools and provide reliable \& frequently captured data. We aim to create a system that can monitoring individual and subsyndromes of NPS; and detect early changes in NPS by automatically quantifying \& detecting relevant behavioral abnormalities based on both intra- \& inter-individual comparisons. Our approach is a video sensor, information processing, \& alert system that utilizes in-home cameras \& ambient sensors with video features that can recognize \& track behaviors securely, pre-defines domains involved in a behavior; personalizes the results by assessing the individual's behavioral norms and the home environment; and analyzes, learns, and provides explainable items from different modalities of data: time, location, video, and audio.
Measured: 2 year
NPS Clinical Dashboard
Overall, the investigators envision the clinical dashboard as a transformative tool that delivers clear and comprehensive data on each individual. Therefore enhancing the quality of diagnosis of NPS for individuals, leading to better patient interventions and more effective long term management strategies.
Measured: 1 year
Secondary outcomes (1)
generate Data and support for a large-scale study or clinical trial within the context of an R01.
the ultimate goal of this project is to generate feasibility data and infrastructure for a large-scale study with a possible clinical trial within the context of an R01. In parallel, to translate the technology into clinical practice, we will work with the Stanford Office of Technology Licensing (OTL) to productize the outcomes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Oct 2024
- Primary completion30 Oct 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Rochester
- Responsible party
- Principal investigator, Ehsan Adeli, Stanford University
- Investigators
- Ehsan Adeli, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704971
- Sponsor's protocol ID
- 68794
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gould CE, Davis CH, Schuz N, Lin FV, Samus QM, Terada T, Daniel M, Tee S, Adeli E. Designing AI-Enabled Video Monitoring Clinician Dashboard for Neuropsychiatric Symptoms: A Survey of User Needs. Am J Geriatr Psychiatry Open Sci Educ Pract. 2026 Mar;9:46-51. doi: 10.1016/j.osep.2026.01.001. Epub 2026 Feb 8.
PubMed 41987876
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Assessment of Neuropsychiatric Symptoms at Home Predictive of Mental Health and Cognitive Disorders Using Non-Intrusive Ambient Intelligence Technologies
- ClinicalTrials.gov ID
- NCT06704971
- Acronym / sponsor ID
- 68794
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Dementia Alzheimers, Dementia, Memory Impairment, NPS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Rochester
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (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.
Neuropsychiatric symptoms (NPS) refer to a range of mental and emotional issues that can be observed through how patients move, perform daily tasks, and express feelings on their faces. In this study, the investigators want to find ways to accurately and unobtrusively track these symptoms in people's homes over time. Our goals are to note when these symptoms happen, predict potential problems, and gather clear data to help doctors make accurate diagnoses.
To do this, the investigators will first collect information from participants who have in-home sensors. the investigators will then use special computer programs that can recognize everyday activities and identify features that connect to scores from the Mild Behavioral Impairment Checklist (MBI-C). These scores will be compared to a questionnaire (NPIQ) filled out by caregivers or family members, along with any relevant information from doctors about the patients' symptoms. The investigators aim to see how these features can help differentiate between types of NPS, such as mood changes and agitation.
Finally, the investigators will create a dashboard for doctors that summarizes the patterns of these symptoms in patients, making it easier to monitor and manage their mental health.
Detailed description
What the investigators would need from participants:
- Collect the participants' own data of daily activities from a room in participants home such as the participant's living room via a small camera the investigators provide for no less than 7 days and up to 30 days. The participant will have full control over the camera to turn on and off.
- The participant and a loved one will regularly answer short surveys asking about the participant's mood and daily functioning.
- At the end of agreed observation period, return the memory card of the participant's collected data from the camera in person or pre-paid FedEx envelope.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older Adults - 65+
Key inclusion criteria (4 listed)
- Age 65+ years old
- Any age and ethnicity.
- With or without, or at risk of mild to moderate dementia and healthy controls.
- Availability of a study partner (informant) who has contact with the patient at least once a week (this can also be the surrogate/LAR but does not necessarily have to be)
Key exclusion criteria (2 listed)
- Those with severe mobility impairments
- participants in non-home settings (skilled nursing facilities, etc.).
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
develop a personalized and clinically interpretable NPS assessment system
Time frame: 2 year
Assessing NPS relies primarily on clinician observation \& interviews with caregivers, usually within brief \& infrequent clinical visits. Precise assessment and monitoring methods would incorporate objective, patient- \& caregiver-friendly, real-time tools and provide reliable \& frequently captured data. We aim to create a system that can monitoring individual and subsyndromes of NPS; and detect early changes in NPS by automatically quantifying \& detecting relevant behavioral abnormalities based on both intra- \& inter-individual comparisons. Our approach is a video sensor, information processing, \& alert system that utilizes in-home cameras \& ambient sensors with video features that can recognize \& track behaviors securely, pre-defines domains involved in a behavior; personalizes the results by assessing the individual's behavioral norms and the home environment; and analyzes, learns, and provides explainable items from different modalities of data: time, location, video, and audio.
NPS Clinical Dashboard
Time frame: 1 year
Overall, the investigators envision the clinical dashboard as a transformative tool that delivers clear and comprehensive data on each individual. Therefore enhancing the quality of diagnosis of NPS for individuals, leading to better patient interventions and more effective long term management strategies.
1 secondary outcome
generate Data and support for a large-scale study or clinical trial within the context of an R01.
Time frame: 2 years
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 18 May 2026.
- Results publication: PubMed 41987876Gould CE, Davis CH, Schuz N, Lin FV, Samus QM, Terada T, Daniel M, Tee S, Adeli E. Designing AI-Enabled Video Monitoring Clinician Dashboard for Neuropsychiatric Symptoms: A Survey of User Needs. Am J Geriatr Psychiatry Open Sci Educ Pract. 2026 Mar;9:46-51. doi: 10.1016/j.osep.2026.01.001. Epub 2026 Feb 8.
- Individual participant dataSharing planned: No
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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.
Ehsan Adeli, PhD principal investigator
Stanford University
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 Mild Cognitive Impairment and Mild Dementia, run by Stanford University at 1 site in United States.
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 2 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 18 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 United States. 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?
develop a personalized and clinically interpretable NPS assessment system (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704971, which also lists 1 linked publication.
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 18 May 2026.