ToolboxDetect for Cognitive Decline

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwestern University, Chicago, IL
Cognitive Decline+1 More
ToolboxDetect - Other
Eligibility
65+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a new tool can help detect cognitive decline in individuals who are not experiencing any symptoms.

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Eligible Conditions

  • Cognitive Decline
  • Dementia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cognitive Decline

Study Objectives

This trial is evaluating whether ToolboxDetect will improve 1 primary outcome and 4 secondary outcomes in patients with Cognitive Decline. Measurement will happen over the course of Up to 3 years.

Up to 3 years
Caregiver involvement
Rate of cognition-related referrals
Rate of cognitive testing
Rate of detected cases with mild impairment
Rate of detected impairment

Trial Safety

Safety Progress

1 of 3

Other trials for Cognitive Decline

Trial Design

2 Treatment Groups

Enhanced Usual Care
1 of 2
ToolboxDetect Strategy
1 of 2
Active Control
Experimental Treatment

This trial requires 41500 total participants across 2 different treatment groups

This trial involves 2 different treatments. ToolboxDetect is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ToolboxDetect Strategy
Other
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.
Enhanced Usual CareAt 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Who is running the study

Principal Investigator
M. S. W.
Prof. Michael S. Wolf, Professor
Northwestern University

Closest Location

Northwestern University - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals aged 65 and older will be considered.
Adults who may or may not have cognitive impairments.
Practices affiliated with Northwestern Medicine and Access Community Health Network.

Patient Q&A Section

What are the common side effects of toolboxdetect?

"Toolboxdetect is an effective and widely available cognitive screening tool in the aging population. Its high sensitivity to cognitive impairments in the aging population makes it a candidate for evaluating the impact of aging-related cognitive symptoms on clinical outcomes, including fall risk and functional decline." - Anonymous Online Contributor

Unverified Answer

What are the signs of cognitive decline?

"There is a wide range of features in the general population of the elderly associated with neuropathological change. There is a strong need for well-designed, prospective studies into the diagnosis of specific brain aging syndromes and for effective dementia preventive strategies." - Anonymous Online Contributor

Unverified Answer

Can cognitive decline be cured?

"Mild cognitive decline is common among older adults and is associated with poorer function. Results from a recent clinical trial suggest that even mildly affected cognitive function should be evaluated in older patients to identify those who may require early intervention to avoid future decline." - Anonymous Online Contributor

Unverified Answer

How many people get cognitive decline a year in the United States?

"The numbers of people who experience cognitive decline in the real world are much larger. It is more than double the numbers reported in academic literature. The reasons for the discrepancy are uncertain but it highlights the fact that there is a lack of studies on cognitive decline in the real world which can be very informative." - Anonymous Online Contributor

Unverified Answer

What is cognitive decline?

"The most common types of post-mature cognitive decline were memory, attention, and executive functions. These impairments are related to the cognitive symptoms of older adults." - Anonymous Online Contributor

Unverified Answer

What causes cognitive decline?

"The causes of cognitive decline are complex. They include the cognitive reserve (brain's ability) in which each person differs; the environment (exposure to risk factors for cognitive decline); and the individual's own age, genetics, and history. It is not possible to identify a single cause, such as a single germ. Understanding the complexity of causation is important for developing effective prevention measures." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cognitive decline?

"There is no single treatment for CAD or ND that can work in every patient. Instead, treatments which are effective in one domain such as memory might not work well in another domain such as thinking in a patient with CAD. There are no clinical trials designed specifically to test a particular treatment for CAD or ND. The majority of treatments for CAD and ND only try general strategies such as addressing the patient's environment and lifestyle and using the treatment they use for other conditions such as depression. These treatments have not been empirically tested for their long-term effectiveness in CAD or ND - so they cannot be recommended on their own and further observational studies are needed to confirm their effectiveness." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cognitive decline?

"Older people generally are better at holding and remembering information than are younger people. As people age, it becomes progressively more difficult to use and control information. In the case of simple information like the age of someone, in a given time frame, the memory may not degrade at a similar rate as the aging of the person. In many cognitive domains, there is a significant effect of age beginning in the mid-70s; by the late 80s, most people cannot hold or recall most information. It is important for caregivers to stay vigilant for cognitive decline, and to continue to keep a record of personal and family histories, as well as other important information." - Anonymous Online Contributor

Unverified Answer

Is toolboxdetect typically used in combination with any other treatments?

"A toolboxdetect scan combined with either TBI or OA may be useful to identify AD. The presence of TBI, especially in conjunction with OA, in elderly people is important for early diagnosis and is independent of cognitive deterioration or dementia." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cognitive decline?

"The study findings do not support an increase in Alzheimer's disease (AD) risk with cumulative exposure to lead in adulthood. The current study findings showed a decrease of a composite measure of AD, which included the clinical diagnoses of AD or mild cognitive impairment (MCI). When analyzed by type of exposure (poetry, music, or lead), there was an interaction effect between cumulative exposure exposure and the measure of AD. For the measure of MCI the results showed some evidence of a decreasing effect of cumulative exposure. As the study analyzed cumulative exposure (poetry, music, or lead), there was an interaction effect between cumulative exposure exposure and the measure of MCI." - Anonymous Online Contributor

Unverified Answer

How serious can cognitive decline be?

"Cognitive decline is common among older people and is associated with reduced quality of life and greater functional disability, and with high-risk of death at all ages. Cognitive deficits may affect our ability to engage in social and physical health-promoting activities." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in toolboxdetect for therapeutic use?

"It seems that newer tools are bringing more information about patient needs and optimizing patient selection for treatment. This information adds to the clinician's ability to select the best treatment for each patient. In the process, physicians should be aware of the increased complexity of this therapy and the need for a clinical gerologist in order to evaluate and manage the patient and to manage the medications." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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