~9110 spots leftby Feb 2026

ToolboxDetect Cognitive Screening for Cognitive Impairment

Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Disqualifiers: Severe vision, hearing impairment
No Placebo Group

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.12345

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.46789

Research Team

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.
See 3 more

Exclusion Criteria

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

Trial 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 (Behavioural Intervention)
Trial OverviewToolboxDetect 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
2Treatment groups
Experimental Treatment
Active Control
Group I: ToolboxDetect StrategyExperimental Treatment1 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 CareActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+
Dr. Jeffrey Sherman profile image

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler profile image

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

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.
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.
The value of assessing cognitive function in drug development.Wesnes, KA.[2023]
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.
Current advances in digital cognitive assessment for preclinical Alzheimer's disease.Öhman, F., Hassenstab, J., Berron, D., et al.[2021]

References

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]
The value of assessing cognitive function in drug development. [2023]
Developments in scalable strategies for detecting early markers of cognitive decline. [2022]
Current advances in digital cognitive assessment for preclinical Alzheimer's disease. [2021]
Unsupervised assessment of cognition in the Healthy Brain Project: Implications for web-based registries of individuals at risk for Alzheimer's disease. [2022]
The trail-making-test: Comparison between paper-and-pencil and computerized versions in young and healthy older adults. [2022]
A novel technology to screen for cognitive impairment in the elderly. [2011]
Integrated Cognitive Assessment: Speed and Accuracy of Visual Processing as a Reliable Proxy to Cognitive Performance. [2023]
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]