Alzheimer DiseaseNCT05082883
Cognitive Screening Made Easy for PCPs
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by University of Texas at Austin at 1 site in United States.
Trial summary
In the United States and around the world, people are living longer lives. As the population ages, so does the number of older adults who may experience declines in memory, attention, reasoning, or other thinking skills. Some of these changes in cognition can be treated and reversed if caught early. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Cognitive Decline
- What is being tested?
- Risk Assessment Cognitive Screening
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults
Who may be able to join
- Cognitively normal must have no cognitive concerns, be independent in all activities of daily living, be medically stable and willing to participate in the study, and fluent in English
- Mild cognitive impairment must have self or informant concern of cognitive decline, impairment in one or more cognitive domains on objective tests when possible, preservation of independence in activities of daily living, be medically stable and willing to participate in the study, and fluent in English
- Mild dementia must exhibit cognitive and/or behavioral symptoms that represent a decline from prior levels of functioning, interfere with the ability to function at work or in usual activities, are not explained by delirium or a major psychiatric disorder, and are evident in at least two cognitive/behavioral domains
Who cannot join
- Cognitively normal and mild cognitive impairment cannot have confounding medical or psychiatric conditions that could impact cognition, dementia of any etiology, or active substance abuse that could impact cognition or substance use disorder not in remission for at least 1 year.
- Dementia cannot have psychiatric conditions that could impact cognition or active substance abuse that could impact cognition or substance use disorder not in remission for at least 1 year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Memory Center, UT Health Austin
Austin, Texas, 78712
About this study
Official title: Cognitive Screening Made Easy for Primary Care Providers
In the United States and around the world, people are living longer lives. As the population ages, so does the number of older adults who may experience declines in memory, attention, reasoning, or other thinking skills. Some of these changes in cognition can be treated and reversed if caught early. Others can be slowed down and hopefully one day prevented. Unfortunately, people with cognitive decline or very mild dementia often are not recognized until late in the disease course when treatments are less effective. As the first health care professional most people reach out to about medical concerns, primary care providers play a critical role in detecting cognitive decline early. While many primary care providers conduct cognitive screening at Medicare Annual Wellness Visits and when patients voice concerns, 9 out of 10 would like more information about who to screen, which assessment tool to use, and what to say if screening is positive. Deciding who to screen with a brief cognitive assessment tool is a key part of the process because not everyone needs to be screened, and primary care providers already face time pressures to address the obvious and immediate concerns of their patients. The long-term goal of this project is to develop a risk assessment and cognitive screening tool that requires minimal time and effort from primary care providers or their staff and is sensitive to cognitive decline in older adults from diverse educational and racial/ethnic backgrounds. The tool will be integrated into electronic health record systems to make it easy for primary care providers and patients to see results. The specific aims of the first phase of the project are to modify an existing dementia risk screening index to identify older adults who are at high-risk for cognitive impairment, develop a brief cognitive assessment tool using tasks that are easy for older adults to perform yet are sensitive to cognitive decline, confirm their utility in 150 people with varying levels of cognitive abilities that have already been well defined, and test ways to integrate findings into the electronic health record. The specific aims for the second phase are to further test the effectiveness of the newly developed tool in 250 older adults receiving care in a primary care clinic, to find out from primary care providers using the tool how much they liked it and if it was useful and easy to use, and to integrate findings into multiple electronic health record systems. Findings from this project will fill a gap in the existing toolkit of primary care providers and will make screening for cognitive decline quick, easy, and effective.
- Being tested
- Risk Assessment Cognitive Screening
- 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.
Risk Assessment Cognitive ScreeningDiagnostic test
Completion of a risk assessment cognitive screening app that includes working memory and voice-based tasks
| Study group | Role | What they receive |
|---|---|---|
| Cognitively Normal | No cognitive impairment, medically stable Receives: Diagnostic Test: Risk Assessment Cognitive Screening | |
| Mild Cognitive Impairment | Meets NIA-AA criteria for MCI Receives: Diagnostic Test: Risk Assessment Cognitive Screening | |
| Mild Dementia | Meets NIA-AA criteria for dementia Receives: Diagnostic Test: Risk Assessment Cognitive Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance score (under development)
Scored will be derived statistically from processing speed/working memory and speech tasks
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start13 Aug 2021
- Primary completion4 Nov 2022
- Study completion1 May 2023
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.
- 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Robin C. Hilsabeck, University of Texas at Austin
- Investigators
- Robin C Hilsabeck, PhD, Principal investigator, University of Texas at Austin Dell Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082883
- Sponsor's protocol ID
- AG069780-01
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All research resources (e.g., methods, tools, materials) and other information developed in this project will be made readily available to the scientific community for non-profit research purposes. As per the proposal guidelines, we will publish all of our code and scripts for statistical analysis and machine learning development on a publically available GitHub repository. We will publish or provide complete recipes for all aspects of data collection and analysis once all references to patient information have been removed. We are committed to sharing our data, models, and software in a practical, user-friendly way; we strongly believe this is required to enable this research to reach its maximum potential. More broadly, the Dell Medical School at the University of Texas at Austin is committed to improving the quality and delivery of care through research discoveries that change clinical practice.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Screening Made Easy for Primary Care Providers
- ClinicalTrials.gov ID
- NCT05082883
- Acronym / sponsor ID
- AG069780-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 19 Oct 2021 (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.
In the United States and around the world, people are living longer lives. As the population ages, so does the number of older adults who may experience declines in memory, attention, reasoning, or other thinking skills. Some of these changes in cognition can be treated and reversed if caught early. Others can be slowed down and hopefully one day prevented. Unfortunately, people with cognitive decline or very mild dementia often are not recognized until late in the disease course when treatments are less effective. As the first health care professional most people reach out to about medical concerns, primary care providers play a critical role in detecting cognitive decline early. While many primary care providers conduct cognitive screening at Medicare Annual Wellness Visits and when patients voice concerns, 9 out of 10 would like more information about who to screen, which assessment tool to use, and what to say if screening is positive. Deciding who to screen with a brief cognitive assessment tool is a key part of the process because not everyone needs to be screened, and primary care providers already face time pressures to address the obvious and immediate concerns of their patients. The long-term goal of this project is to develop a risk assessment and cognitive screening tool that requires minimal time and effort from primary care providers or their staff and is sensitive to cognitive decline in older adults from diverse educational and racial/ethnic backgrounds. The tool will be integrated into electronic health record systems to make it easy for primary care providers and patients to see results. The specific aims of the first phase of the project are to modify an existing dementia risk screening index to identify older adults who are at high-risk for cognitive impairment, develop a brief cognitive assessment tool using tasks that are easy for older adults to perform yet are sensitive to cognitive decline, confirm their utility in 150 people with varying levels of cognitive abilities that have already been well defined, and test ways to integrate findings into the electronic health record. The specific aims for the second phase are to further test the effectiveness of the newly developed tool in 250 older adults receiving care in a primary care clinic, to find out from primary care providers using the tool how much they liked it and if it was useful and easy to use, and to integrate findings into multiple electronic health record systems. Findings from this project will fill a gap in the existing toolkit of primary care providers and will make screening for cognitive decline quick, easy, and effective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitively Normal | – | Diagnostic Test: Risk Assessment Cognitive ScreeningNo cognitive impairment, medically stable |
| Mild Cognitive Impairment | – | Diagnostic Test: Risk Assessment Cognitive ScreeningMeets NIA-AA criteria for MCI |
| Mild Dementia | – | Diagnostic Test: Risk Assessment Cognitive ScreeningMeets NIA-AA criteria for dementia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults
Key inclusion criteria (3 listed)
- Cognitively normal must have no cognitive concerns, be independent in all activities of daily living, be medically stable and willing to participate in the study, and fluent in English
- Mild cognitive impairment must have self or informant concern of cognitive decline, impairment in one or more cognitive domains on objective tests when possible, preservation of independence in activities of daily living, be medically stable and willing to participate in the study, and fluent in English
- Mild dementia must exhibit cognitive and/or behavioral symptoms that represent a decline from prior levels of functioning, interfere with the ability to function at work or in usual activities, are not explained by delirium or a major psychiatric disorder, and are evident in at least two cognitive/behavioral domains
Key exclusion criteria (2 listed)
- Cognitively normal and mild cognitive impairment cannot have confounding medical or psychiatric conditions that could impact cognition, dementia of any etiology, or active substance abuse that could impact cognition or substance use disorder not in remission for at least 1 year.
- Dementia cannot have psychiatric conditions that could impact cognition or active substance abuse that could impact cognition or substance use disorder not in remission for at least 1 year.
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 |
|---|---|---|
| Risk Assessment Cognitive ScreeningCompletion of a risk assessment cognitive screening app that includes working memory and voice-based tasks | Diagnostic test | Cognitively Normal, Mild Cognitive Impairment, Mild Dementia |
Primary outcome
Cognitive Performance score (under development)
Time frame: 10 minutes
Scored will be derived statistically from processing speed/working memory and speech tasks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Yes. All research resources (e.g., methods, tools, materials) and other information developed in this project will be made readily available to the scientific community for non-profit research purposes. As per the proposal guidelines, we will publish all of our code and scripts for statistical analysis and machine learning development on a publically available GitHub repository. We will publish or provide complete recipes for all aspects of data collection and analysis once all references to patient information have been removed. We are committed to sharing our data, models, and software in a practical, user-friendly way; we strongly believe this is required to enable this research to reach its maximum potential. More broadly, the Dell Medical School at the University of Texas at Austin is committed to improving the quality and delivery of care through research discoveries that change clinical practice.
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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.
Robin C Hilsabeck, PhD principal investigator
University of Texas at Austin Dell Medical School
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 and Mild Cognitive Impairment, run by University of Texas at Austin 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 3 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: finished, as of the sponsor's last update on 30 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive Performance score (under development) (time frame: 10 minutes). 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 30 Nov 2023.