Alzheimer DiseaseSPPB++NCT06489847
An Objective Assessment Tool for Evaluating Functioning in Older Adults
An observational study of Alzheimer Disease, run by Stanford University at 1 site in United States.
Trial summary
The Investigators are seeking your consent to participate in research investigating the development of a mobile application that enhances physical and cognitive assessments. This is in response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- SPPB++ Application
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Oct 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Adults
Who may be able to join
- Adult (18+)
- proficient in English
- consider themselves healthy
- Ability to participate in a meeting for consenting and video data collection on Stanford campus
Who cannot join
- We will exclude participant that do not consent to video data collection
- Under the age of 18
- limited physical mobility.
- We have no exclusions on the basis of gender or ethnic background.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Excellence Research Center
Palo Alto, California, 94304
About this study
The Investigators are seeking your consent to participate in research investigating the development of a mobile application that enhances physical and cognitive assessments.
This is in response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias (AD/ADRD) research. The SPPB has proven its value in evaluating lower extremity function and mobility in older adults, providing predictive insights into declines in daily living activities, falls, hospitalization, disability, and mortality.
Read more
Recognizing the need for accessible and automated assessment tools, this project endeavors to design a mobile app with multi-fold functionality. The final version will guide users through SPPB tests, offer real-time performance scoring, and facilitate frequent, objective, and accurate physical and cognitive assessments. This is particularly critical for monitoring the progression of ADRD, identifying subtle physical changes indicative of cognitive decline, and enabling timely interventions tailored to patients' evolving needs.
Our goal is to collect video data from 20 to 30 participants 18+ years of age who are considered healthy with no severe mobility issues to perform the SPPB. The video data will be used to develop a prototype of the SPPB application and validate testing in the lab. The video recording will be automatically encrypted and securely uploaded to Stanford privacy protected computer servers to test and refine the application results.
Read the detailed description
In response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias (AD/ADRD) research, this project aims to create a mobile application that enhances physical and cognitive assessments. The SPPB has proven its value in evaluating lower extremity function and mobility in older adults, providing predictive insights into declines in daily living activities, falls, hospitalization, disability, and mortality. Moreover, recent research has revealed the potential of SPPB in detecting cognitive decline through gait and hand movement analysis at various stages of AD and Mild Cognitive Impairment (MCI). Recognizing the need for accessible and automated assessment tools, this project endeavors to design a mobile app with multi-fold functionality. It will guide users through SPPB tests, offer real-time performance scoring, and facilitate frequent, objective, and accurate physical and cognitive assessments. This is particularly critical for monitoring the progression of ADRD, identifying subtle physical changes indicative of cognitive decline, and enabling timely interventions tailored to patients' evolving needs.
- Conditions
- Alzheimer Disease
- Being tested
- SPPB++ Application
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPPB++ ApplicationDiagnostic test
Participants will have video data collected as they perform the SPPB test one time.
What is being measured
The primary outcome is the main question the study is designed to answer.
develop an automated analysis of the SPPB clinical tests
Novel Biomarker Types: In this study, we propose to leverage video data to develop an automated analysis of the SPPB clinical tests, the same way that MRI data can automatically be analyzed. This will remove the need for subjective evaluation and lead to universally acceptable disease (digital) biomarkers from the video data, helping the clinicians. The video-based biomarkers will serve as quantifiable identifiers singling out specific subtype(s). Such digital biomarkers [9-19,21] and especially video [20] are transforming the development of drugs. Video, as a rich source of data, can provide novel information yet to be explored.
Measured: 1 year
large-scale data collection to continuously collect data for understanding NPS disease trajectories
Novel Methodologies: Processing unconstrained video data collected in clinical settings with limited data points calls for new technologies. Although we use recent video recognition technologies (including those developed by us recently), applying them to clinical data and training new machine learning models poses unique challenges requiring novel methods. In addition, implementing this on mobile phones will facilitate the platforms required for large-scale data collection to continuously collect data for understanding disease trajectories.
Measured: 1 year
SPPB++ mobile phone app
Impact: We will implement our novel algorithms in a mobile phone app, making the tests accessible and affordable to many individuals. This will enable large-scale data collection and clinical trials. The analysis of this data will identify novel biomarkers using video-based SPPB tests. The longitudinal assessment of these tests will provide a means for tracking cognitive functioning and convergence to MCI, AD, or other dementia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Ehsan Adeli, Stanford University
- Investigators
- Ehsan Adeli, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489847
- Sponsor's protocol ID
- 74617
- Acronym
- SPPB++
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Objective Assessment Tool for Evaluating Functioning in Older Adults
- ClinicalTrials.gov ID
- NCT06489847
- Acronym / sponsor ID
- SPPB++ / 74617
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 8 Jul 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.
The Investigators are seeking your consent to participate in research investigating the development of a mobile application that enhances physical and cognitive assessments.
This is in response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias (AD/ADRD) research. The SPPB has proven its value in evaluating lower extremity function and mobility in older adults, providing predictive insights into declines in daily living activities, falls, hospitalization, disability, and mortality.
Recognizing the need for accessible and automated assessment tools, this project endeavors to design a mobile app with multi-fold functionality. The final version will guide users through SPPB tests, offer real-time performance scoring, and facilitate frequent, objective, and accurate physical and cognitive assessments. This is particularly critical for monitoring the progression of ADRD, identifying subtle physical changes indicative of cognitive decline, and enabling timely interventions tailored to patients' evolving needs.
Our goal is to collect video data from 20 to 30 participants 18+ years of age who are considered healthy with no severe mobility issues to perform the SPPB. The video data will be used to develop a prototype of the SPPB application and validate testing in the lab. The video recording will be automatically encrypted and securely uploaded to Stanford privacy protected computer servers to test and refine the application results.
Detailed description
In response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias (AD/ADRD) research, this project aims to create a mobile application that enhances physical and cognitive assessments. The SPPB has proven its value in evaluating lower extremity function and mobility in older adults, providing predictive insights into declines in daily living activities, falls, hospitalization, disability, and mortality. Moreover, recent research has revealed the potential of SPPB in detecting cognitive decline through gait and hand movement analysis at various stages of AD and Mild Cognitive Impairment (MCI). Recognizing the need for accessible and automated assessment tools, this project endeavors to design a mobile app with multi-fold functionality. It will guide users through SPPB tests, offer real-time performance scoring, and facilitate frequent, objective, and accurate physical and cognitive assessments. This is particularly critical for monitoring the progression of ADRD, identifying subtle physical changes indicative of cognitive decline, and enabling timely interventions tailored to patients' evolving needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Adults
Key inclusion criteria (4 listed)
- Adult (18+)
- proficient in English
- consider themselves healthy
- Ability to participate in a meeting for consenting and video data collection on Stanford campus
Key exclusion criteria (4 listed)
- We will exclude participant that do not consent to video data collection
- Under the age of 18
- limited physical mobility.
- We have no exclusions on the basis of gender or ethnic background.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPPB++ ApplicationParticipants will have video data collected as they perform the SPPB test one time. | Diagnostic test | – |
Primary outcome
develop an automated analysis of the SPPB clinical tests
Time frame: 1 year
Novel Biomarker Types: In this study, we propose to leverage video data to develop an automated analysis of the SPPB clinical tests, the same way that MRI data can automatically be analyzed. This will remove the need for subjective evaluation and lead to universally acceptable disease (digital) biomarkers from the video data, helping the clinicians. The video-based biomarkers will serve as quantifiable identifiers singling out specific subtype(s). Such digital biomarkers [9-19,21] and especially video [20] are transforming the development of drugs. Video, as a rich source of data, can provide novel information yet to be explored.
large-scale data collection to continuously collect data for understanding NPS disease trajectories
Time frame: 1 year
Novel Methodologies: Processing unconstrained video data collected in clinical settings with limited data points calls for new technologies. Although we use recent video recognition technologies (including those developed by us recently), applying them to clinical data and training new machine learning models poses unique challenges requiring novel methods. In addition, implementing this on mobile phones will facilitate the platforms required for large-scale data collection to continuously collect data for understanding disease trajectories.
SPPB++ mobile phone app
Time frame: 1 year
Impact: We will implement our novel algorithms in a mobile phone app, making the tests accessible and affordable to many individuals. This will enable large-scale data collection and clinical trials. The analysis of this data will identify novel biomarkers using video-based SPPB tests. The longitudinal assessment of these tests will provide a means for tracking cognitive functioning and convergence to MCI, AD, or other dementia.
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 29 Apr 2026.
- 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 Alzheimer Disease, 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 4 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 29 Apr 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 an automated analysis of the SPPB clinical tests (time frame: 1 year). The study lists 3 primary outcomes in all. 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 29 Apr 2026.