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

Trial Summary

What is the purpose of this trial?

Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. This strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings, and is responsive to patient, family, and caregiver concerns for potential symptoms of cognitive decline (CD) and cognitive impairment (CI).

Will I have to stop taking my current medications?

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

Is ToolboxDetect Cognitive Screening safe for humans?

The available research does not provide specific safety data for ToolboxDetect Cognitive Screening or its related names. However, it is described as a non-invasive, self-administered cognitive assessment tool, which suggests it is generally safe for use in humans. ^{1 2 3 4 5}

How is the ToolboxDetect treatment different from other treatments for cognitive impairment?

ToolboxDetect is unique because it is a portable device that allows for rapid cognitive testing in various settings, unlike traditional methods that are often paper-based, time-consuming, and require a healthcare professional. This makes it more practical for widespread screening and early detection of cognitive impairment. ^{4 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Developments in scalable strategies for detecting early markers of cognitive decline. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Current advances in digital cognitive assessment for preclinical Alzheimer's disease. [2021]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

A novel technology to screen for cognitive impairment in the elderly. [2011]

8. England pubmed.ncbi.nlm.nih.gov

Integrated Cognitive Assessment: Speed and Accuracy of Visual Processing as a Reliable Proxy to Cognitive Performance. [2023]

9. United States 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. [2022]