Cognitive Screening Tools for Dementia

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Multiple study sites

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Cognitive Risk Calculator and Screening Tool, to help doctors identify early signs of dementia, a condition affecting memory and thinking skills. The goal is to determine if this tool changes how doctors assess and treat patients. The trial compares clinics using the tool with those not yet using it to observe differences in care. Participating doctors should see patients aged 60 or older and work at one clinic site. As an unphased trial, this study allows patients to contribute to innovative research that could enhance early dementia detection and care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this cognitive screening tool is safe?

Research has shown that cognitive screening tools like the Cognitive Risk Calculator and the Brief Assessment of Cognitive Health (BACH) are generally safe. These tools help identify individuals at risk for dementia or mild cognitive impairment (MCI). Studies have found that these tools can more accurately identify patients with dementia or MCI compared to some older methods.

The Cognitive Risk Calculator uses data from electronic health records to identify patients for cognitive screening before symptoms appear, making it an affordable and easy-to-use option. Importantly, no serious side effects have been reported from using these tools, indicating they are well-tolerated by patients.

Overall, evidence suggests these tools are safe and could be a useful part of regular health check-ups, especially for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to screen for dementia using the Cognitive Risk Calculator (RC) and the Brief Assessment of Cognitive Health (BACH). Unlike traditional methods that often rely on lengthy assessments or invasive tests, these tools offer a quick and non-invasive approach to identifying cognitive decline. The RC and BACH are designed to be user-friendly and accessible, potentially allowing for earlier detection and intervention in dementia, which is crucial for managing the condition effectively. This trial represents a significant step forward in making dementia screening more efficient and widely available.

What evidence suggests that this cognitive screening tool is effective for dementia?

Research has shown that a computerized tool, which participants in this trial may experience, can identify individuals at high risk for memory and thinking problems before symptoms appear. Integrated into electronic health records (EHR), this tool helps doctors determine which patients should be evaluated for these issues during regular visits. Studies have found that using this tool leads to earlier tests for memory problems, potentially catching dementia sooner. Additionally, these automated tools assist doctors in deciding which older adults need memory tests, streamlining management in busy clinics. Early detection may help slow memory and thinking decline. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for primary care settings within the Cleveland Clinic Health System. It's designed to assess how well a new cognitive risk calculator and screening tool work in real-world clinics. The study will look at whether these tools change how doctors manage dementia risks.

Inclusion Criteria

Must be a prescribing provider

I am a healthcare provider who treats adults 60 years or older.

Exclusion Criteria

Provider sees patients at more than one participating study site

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Prior to implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

up to 1 year

Active Phase

Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Risk Calculator and Screening Tool

Trial Overview The trial is testing a cognitive risk calculator and an automated screening tool called BACH, aiming to improve early detection of dementia. Clinics are randomly chosen over time to start using these tools, allowing researchers to compare results across different stages.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Active Phase: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

Group II: Control Active Control 1 Intervention

Control Phase: Prior to implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a survey of 3712 patients, 863 were prescribed anti-dementia drugs, with 21% experiencing confirmed adverse events, primarily excitation/anxiety (45.1%).

Risk factors for these adverse events included polypharmacy (taking 10 or more medications), inappropriate use of anti-dementia drugs, and irregular medication adherence, highlighting the need for careful medication management by healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of and risk factors for adverse events in Alzheimer's patients receiving anti-dementia drugs in at-home care. Imai, H., Hirai, T., Kumazawa, R., et al.[2020]

In a study of 46,737 Medicare beneficiaries and 29,496 Danish participants, cholinesterase inhibitors like donepezil showed similar cardiovascular safety profiles, with no significant differences in the risk of myocardial infarction (MI) or heart failure compared to other medications.

Memantine was linked to a higher risk of fatal or nonfatal MI and cardiac death in the Danish cohort, as well as increased all-cause mortality in both cohorts, suggesting that patients prescribed memantine may have been sicker overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cardiovascular safety of dementia medications: a cross-national study. Fosbøl, EL., Peterson, ED., Holm, E., et al.[2018]

Citations

1. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/automated-risk-calculator-for-cognitive-screening

Automated Risk Calculator Prompts Cognitive Screening A low-cost, scalable risk calculator based on EHR data shows promise for flagging patients for cognitive screening before symptoms appear.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06506877

A Cognitive Risk Calculator and Screening Tool for Primary ... The first tool is a Cognitive Risk-Calculator (RC), integrated into the Electronic Health Record, to help providers identify patients who are at high risk of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12501348/

A critical review and classification of dementia risk ... A risk indicator is a variable that indicates cognitive decline or neurodegeneration and hence is not independent of the outcome [20]. Examples ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/dad2.70136

Automated identification of older adults at risk for cognitive ... Automated models that predict cognitive risk in older adults can aid decisions about which patients to screen in busy primary care settings.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0749379725005926

Systematic Review of Dementia Risk Screening Tools in ... The online screening and intervention program, Maintain Your Brain, was recently shown to reduce cognitive decline and lifestyle risk factors ( ...

6. alz.org alz.org/getmedia/9687d51e-641a-43a1-a96b-b29eb00e72bb/cognitive-assessment-toolkit

COGNITIVE ASSESSMENT TOOLKIT The use of a brief, structured cognitive assessment tool correctly classifies patients with dementia or mild cognitive impairment (MCI) more often than ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4119094/

Development and validation of a brief dementia screening ... The Dementia Screening Indicator is a simple tool that may be useful in primary care settings to identify high-risk patients to target for cognitive screening.

8. cogdrisk.neura.edu.au cogdrisk.neura.edu.au/

Cognitive Health and Dementia Risk Assessment Discover your personal risk profile. Start Assessment. The Cognitive Health and Dementia Risk Assessment Tool is supported and developed by NeuRA and UNSW.