- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704971
Assessing Cognitive Decline at Home
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- Clinical Excellence Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- 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)
Exclusion criteria:
- Those with severe mobility impairments
- participants in non-home settings (skilled nursing facilities, etc.).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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develop a personalized and clinically interpretable NPS assessment system
Time Frame: 2 year
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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.
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2 year
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NPS Clinical Dashboard
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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generate Data and support for a large-scale study or clinical trial within the context of an R01.
Time Frame: 2 years
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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.
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ehsan Adeli, PhD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Tauopathies
- Neurodegenerative Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Cognitive Dysfunction
- Alzheimer Disease
- Dementia
- Memory Disorders
Other Study ID Numbers
- 68794
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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