ClinicalTrials.gg
CompletedNCT05082883Updated Nov 30, 2023

Cognitive Screening Made Easy for PCPs

An observational study in Alzheimer Disease, Mild Cognitive Impairment and Cognitive Decline, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by University of Texas at Austin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
152
Ages
60 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Cognitive Decline
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In context

Alzheimer Disease

3,766 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 152 is below the median of 200 across 780 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 326 studies on the registry; 78 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Older adults

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
152 participants (actual)
Patient registry
No

Groups and cohorts

  • Cognitively Normal

    No cognitive impairment, medically stable

    Diagnostic Test: Risk Assessment Cognitive Screening

  • Mild Cognitive Impairment

    Meets NIA-AA criteria for MCI

    Diagnostic Test: Risk Assessment Cognitive Screening

  • Mild Dementia

    Meets NIA-AA criteria for dementia

    Diagnostic Test: Risk Assessment Cognitive Screening

Interventions

  • Diagnostic testRisk Assessment Cognitive Screening

    Completion of a risk assessment cognitive screening app that includes working memory and voice-based tasks

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What researchers measure

Primary outcomes

  1. Cognitive Performance score (under development)

    Scored will be derived statistically from processing speed/working memory and speech tasks

    Time frame: 10 minutes

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Study locations

1 site
  • Comprehensive Memory Center, UT Health Austin
    Austin, Texas 78712, United States
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References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: One year after study completion

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Nov 2022, 14 months.

Of 351 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's 14 months is below that.

Counting every sponsor, half of 387 studies reached it within 67 months; a quarter within 36 and three quarters within 140.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2021
First posted
Oct 19, 2021
StartActual
Aug 13, 2021
Primary completionActual
Nov 4, 2022
CompletionActual
May 1, 2023
Last update
Nov 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05082883
Responsible party
Robin C. Hilsabeck (Associate Professor of Neurology, University of Texas at Austin) — Principal investigator
First posted
Oct 19, 2021
Start date
Aug 13, 2021
Primary completion
Nov 4, 2022
Completion
May 1, 2023
Last update
Nov 30, 2023

Study contacts

Robin C Hilsabeck, PhD
principal investigator · University of Texas at Austin Dell Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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