ToolboxDetect Cognitive Screening for Cognitive Impairment

Overseen By Julia Yoshino Benavente, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Severe vision, hearing impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

41500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, ToolboxDetect, designed to spot early signs of memory and thinking problems in older adults. The goal is to enable doctors to identify cognitive decline more easily and quickly, allowing for earlier intervention. The trial compares this tool with the standard tests used during routine health check-ups. It is particularly suitable for individuals aged 65 and older who are patients at Northwestern Medicine or Access Community Health Network and may notice changes in their memory or thinking skills. As an unphased trial, participants can contribute to innovative research that could enhance early detection of cognitive issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ToolboxDetect strategy is safe for cognitive screening?

Research has shown that ToolboxDetect uses two well-proven tests from the NIH Toolbox Cognition Battery. These tests are easy to perform independently and focus on memory and decision-making skills. The NIH Toolbox is widely recognized for providing reliable and consistent results.

No specific side effects or safety issues have been reported with ToolboxDetect. As a tool for assessing cognitive skills, rather than a drug or medical procedure, it is generally considered safe and comfortable for use in clinical settings. The aim is to quickly identify any decline in cognitive abilities without causing discomfort or harm to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ToolboxDetect cognitive screening method because it offers a new, efficient way to assess cognitive impairment. Unlike traditional tests like the Mini-Cog, MoCA, or MMSE that are administered by a clinician, ToolboxDetect is self-administered using an app on an iPad or computer, making it easy to integrate into routine healthcare visits. It includes the NIH Toolbox Picture Sequence Memory Test and the Dimensional Change Card Sorting Test, which assess episodic memory and executive functioning, respectively. By streamlining cognitive assessments and providing immediate, standardized results, ToolboxDetect could enhance early detection and management of cognitive impairment in primary care settings.

What evidence suggests that the ToolboxDetect strategy is effective for detecting cognitive impairment?

Research has shown that the ToolboxDetect method, which participants in this trial may receive, uses tools from the NIH Toolbox to effectively measure thinking and memory skills. This includes tests like the Picture Sequence Memory Test for memory and the Dimensional Change Card Sorting for problem-solving skills. These tests have proven reliable in identifying memory and thinking problems. Individuals who have used similar tests have successfully identified issues with their cognitive abilities. The ToolboxDetect method is easy to use and can be done independently, making it a practical option for regular cognitive health checks. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 65 and older who may or may not have signs of cognitive decline, such as memory loss or confusion. They must be able to see and hear well enough to participate in the tests. Participants will come from practices linked with Northwestern Medicine and Access Community Health Network.

Inclusion Criteria

I may or may not have issues with my memory or thinking.

Practices affiliated with Northwestern Medicine and Access Community Health Network

I am 65 years old or older.

Exclusion Criteria

I have severe vision or hearing loss that cannot be corrected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of ToolboxDetect as a standard of care for cognitive assessment during Medicare Annual Wellness Visits

Up to 3 years

Routine visits as part of Annual Wellness Visits

Follow-up

Participants are monitored for cognitive decline detection and management effectiveness

Up to 3 years

Follow-up visits post AWV

What Are the Treatments Tested in This Trial?

Interventions

• ToolboxDetect

Trial Overview ToolboxDetect is being tested; it's a new strategy using electronic health records to spot early signs of cognitive decline in diverse primary care settings. It aims to be user-friendly, efficient, and sensitive to concerns about memory problems.

How Is the Trial Designed?

Group I: ToolboxDetect Strategy Experimental Treatment 1 Intervention

All practices randomized to the intervention arm will implement the ToolboxDetect battery as the standard of care routine cognitive assessment to fulfill the Medicare Annual Wellness Visit (AWV) requirement. The 7-8 minute ToolboxDetect battery contains self-administered versions of the NIH ToolBox Picture Sequence Memory Test (PSM) and the NIH ToolBox Dimensional Change Card Sorting (DCCS). PSM measures episodic memory and DCCS tests executive functioning. The validated ToolboxDetect application will be imparted either as an application on an iPad or on a PC desktop/laptop computer commonly found in a clinical exam room for EHR access.

Group II: Enhanced Usual Care Active Control 1 Intervention

At Northwestern Medicine, cognitive assessments included in Annual Wellness Visits or other routine or sick/problem-based visits vary by practice and also by clinician. However, the choice of test was limited to either a Mini-Cog©, Montreal Cognitive Assessment (MoCA), or Mini Mental Status Exam (MMSE). While we will not make any explicit recommendations to these practices with regard to their use of a cognitive assessment, we will ensure that 1) any chosen test is linked to an Epic SmartData element, which will allow the clinician to record the results of the test as discrete data (which can then be queried), and that 2) providers receive a compiled list of local medical and non-medical referrals for any detected cases of CI. The Alzheimer's Association recommendations for early detection efforts among primary care practices will also be provided to each clinic's medical leadership.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

ACCESS Community Health Network

Collaborator

Trials

7

Recruited

62,700+

Published Research Related to This Trial

The MyCog paradigm is an iPad-based cognitive assessment tool designed to improve the early detection of cognitive impairment and Alzheimer's disease in diverse primary care settings, specifically targeting low socioeconomic, Black, and Hispanic older adults.

This study will involve 24 primary care practices and over 45,000 patients over a 3-year period, comparing the effectiveness of the MyCog intervention against usual care in identifying cognitive deficits and improving care planning for dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm. Lovett, R., Bonham, M., Yoshino Benavente, J., et al.[2023]

The Integrated Cognitive Assessment (CGN_ICA) is a new 5-minute computerized tool that effectively assesses cognitive performance, showing excellent reliability and validity when compared to standard pen-and-paper tests like the MoCA and SDMT.

With 448 participants of varying ages and education levels, CGN_ICA addresses limitations of traditional cognitive assessments, making it suitable for large-scale screening and monitoring of cognitive impairment in neurodegenerative disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Cognitive Assessment: Speed and Accuracy of Visual Processing as a Reliable Proxy to Cognitive Performance. Khaligh-Razavi, SM., Habibi, S., Sadeghi, M., et al.[2023]

Measuring cognitive function using the Cognitive Drug Research computerized assessment system in clinical trials can provide valuable insights from the very first phase of testing, helping to ensure that new medications do not impair cognitive abilities or interact negatively with other substances.

Incorporating cognitive function assessments into drug development is essential, as it allows for a nuanced understanding of how new treatments affect cognitive abilities, which is particularly important for conditions like dementia, and future advancements in testing methods, such as telephone and internet assessments, will enhance the feasibility of these evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of assessing cognitive function in drug development. Wesnes, KA.[2023]

New strategies for detecting early cognitive decline are being developed that are non-invasive, cost-effective, and can be conducted outside of traditional laboratory settings, making them suitable for large-scale monitoring.

These methods include using peripheral blood samples to identify neuropathology, smartphone technology for passive monitoring of speech and movement, and gamified cognitive tasks, which could significantly improve early detection of cognitive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in scalable strategies for detecting early markers of cognitive decline. Whelan, R., Barbey, FM., Cominetti, MR., et al.[2022]

In a study involving 1594 middle-aged adults, unsupervised cognitive testing using the Cogstate Brief Battery showed high acceptability with 98% of participants completing the assessments, indicating that this method is well-received.

The tests also demonstrated high usability, with 95% of participants achieving low error rates and high learnability, confirming that unsupervised cognitive assessments can provide valid measures of cognitive function, especially in contexts like Alzheimer's disease risk registries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsupervised assessment of cognition in the Healthy Brain Project: Implications for web-based registries of individuals at risk for Alzheimer's disease. Perin, S., Buckley, RF., Pase, MP., et al.[2022]

The DETECT device effectively identifies and differentiates between normal cognitive function, mild cognitive impairment (MCI), and dementia in older adults, showing a strong correlation with expert neuropsychologist assessments in a study of 405 participants aged 65 and older.

With a predictive modeling accuracy of 0.85 for any cognitive impairment and 0.99 for dementia, DETECT offers a rapid and practical alternative for cognitive screening, making it suitable for widespread use in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel technology to screen for cognitive impairment in the elderly. Wright, DW., Nevárez, H., Kilgo, P., et al.[2011]

The Memory Guard (MG) screening tool for mild cognitive impairment (MCI) demonstrated high accuracy (93.75%) and strong predictive performance with an area under the curve (AUC) of 0.923, based on a validation study involving 333 participants.

MG effectively integrates various cognitive dimensions and features, including demographic data and performance scores, making it a reliable and valid tool for early detection of MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validity of computerized neuropsychological assessment devices for screening mild cognitive impairment: Ensemble of models with feature space heterogeneity and retrieval practice effect. Xiao, Y., Jia, Z., Dong, M., et al.[2022]

Digital cognitive assessments for preclinical Alzheimer's disease (AD) are evolving rapidly, utilizing various platforms like smartphones and digital pens, and show promising validity when compared to traditional assessment methods and biomarkers.

Initial data from at least 11 studies indicate that these digital assessments can effectively track cognitive changes in clinically normal individuals, suggesting they could play a significant role in the future of AD screening and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current advances in digital cognitive assessment for preclinical Alzheimer's disease. Öhman, F., Hassenstab, J., Berron, D., et al.[2021]

The digital version of the Trail-Making-Test (dTMT) shows high reliability and strong correlation with the traditional paper-pencil version (ppTMT), making it a valid alternative for assessing cognitive performance in individuals aged 19 to 82.

The dTMT not only effectively distinguishes between younger and older adults but also offers enhanced sensitivity and additional measures, suggesting its potential as an early diagnostic tool for cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The trail-making-test: Comparison between paper-and-pencil and computerized versions in young and healthy older adults. Park, SY., Schott, N.[2022]

Citations

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Cognition assessment using the NIH Toolbox - PMC Cognition is 1 of 4 domains measured by the NIH Toolbox for the Assessment of Neurological and Behavioral Function (NIH-TB), and complements ...

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ToolBox Detect: Low Cost Detection of Cognitive Decline in ... ToolboxDetect is an iPad-based, self-administered assessment that leverages two well validated measures from the NIH Toolbox Cognition Battery: Dimensional ...