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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).

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 data supports the effectiveness of the Cognitive Risk Calculator and Screening Tool treatment for dementia?

The Cognitive Risk Calculator and Screening Tool is supported by research showing that risk assessment tools, like the Dementia Risk Assessment (DRA), can effectively identify individuals at high risk for dementia, which may lead to earlier detection and diagnosis. These tools have shown promise in predicting dementia risk and encouraging clinical evaluation, which is crucial for managing and potentially reducing the impact of dementia. ^{1 2 3 4 5}

Is the Cognitive Screening Tool for Dementia safe for humans?

There is no specific safety data available for the Cognitive Screening Tool for Dementia, but it is generally a non-invasive assessment tool used to identify individuals at risk for cognitive impairment. ^{1 4 6 7 8}

How does the Cognitive Risk Calculator and Screening Tool treatment differ from other dementia treatments?

The Cognitive Risk Calculator and Screening Tool is unique because it focuses on identifying individuals at high risk for dementia through an internet-based assessment, which includes questions about known risk factors and a memory test. This approach allows for early detection and encourages clinical evaluation, differing from traditional treatments that typically address symptoms after diagnosis. ^{1 3 5 6 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of the CogDrisk Instrument as Predictive of Dementia in Four General Community-Dwelling Populations. [2023]

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

Development of the CogDrisk tool to assess risk factors for dementia. [2022]

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

Internet-based screening for dementia risk. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Contributions of a risk assessment approach to the prevention of Alzheimer's disease and dementia. [2014]

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

Preliminary findings from an internet-based dementia risk assessment. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Brief Report: Using the Internet to Identify Persons with Cognitive Impairment for Participation in Clinical Trials. [2020]

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

Comparative cardiovascular safety of dementia medications: a cross-national study. [2018]

8. United States 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. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The validity and reliability of a Computerized Dementia Screening Test developed in Korea. [2019]