5-Cog Assessment for Dementia

Recruiting at 2 trial locations

Overseen By Erica Weiss, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Prior dementia, Nursing facility residents

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

Compensation: Varies

Number of Visits: 1

Duration: 90 days

6600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, quick cognitive test called the 5-Cog Paradigm, designed to detect early signs of memory and thinking issues related to dementia. Researchers are using it in primary care settings to determine if it helps doctors identify cognitive impairment more frequently, especially in underserved communities. Individuals aged 65 or older who have noticed memory problems and can communicate in English or Spanish might be suitable for this trial. The trial aims to increase the detection of cognitive issues and enhance dementia care. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could improve early detection of cognitive issues.

Will I have to stop taking my current medications?

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

What prior data suggests that the 5-Cog Paradigm is safe for cognitive assessment in older adults?

Research has shown that the 5-Cog Paradigm is a safe and easy tool for identifying memory and thinking problems in older adults. This test takes less than five minutes and includes simple tasks like remembering things and matching patterns. Studies indicate it greatly improves the detection of these issues. No reports of problems or safety concerns have emerged from its use, suggesting that the 5-Cog Paradigm is safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 5-Cog Paradigm because it offers a quick and efficient way to identify cognitive impairment in older adults. Unlike traditional methods that can be time-consuming and require specialized settings, the 5-Cog Paradigm is a simple, less than 5-minute cognitive assessment that can be easily integrated into primary care visits. It uses a unique combination of a cognitive test battery and a clinical decision support tool to guide primary care physicians in evaluating cognitive concerns. By providing immediate, actionable insights through electronic medical records, it empowers doctors to make informed decisions without having to strictly adhere to the tool's suggestions. This innovative approach has the potential to streamline the identification and management of dementia in primary care settings.

What evidence suggests that the 5-Cog Paradigm is effective for detecting cognitive impairment?

Research has shown that the 5-Cog method, which participants in this trial may receive, greatly improves the detection of memory and thinking problems in older adults. Studies found that using 5-Cog resulted in more than eight times as many new diagnoses of issues like mild memory loss and dementia. It also increased actions taken for dementia care by over three times. This tool is quick, taking less than five minutes, and helps doctors make earlier and more consistent diagnoses. The 5-Cog method is particularly useful because it performs well across different cultures and literacy levels, making it a fair option for people from diverse backgrounds. Meanwhile, the trial's other arm, Enhanced Usual Care, involves educational sessions for primary care physicians and clinic staff, which may also aid in cognitive detection and care. ^{1 2 3 4 6}

Who Is on the Research Team?

Malaz Boustani, MD, MPH

Principal Investigator

Indiana University

Joe Verghese, MD

Principal Investigator

Stony Brook University

Erica Weiss, PhD

Principal Investigator

Albert Einstein College of Medicie

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who have concerns about their memory or thinking but haven't been diagnosed with dementia. It's not open to those already diagnosed with dementia or living permanently in nursing facilities.

Inclusion Criteria

Presence of cognitive concerns

I am 65 years old or older.

Exclusion Criteria

I live in a nursing home permanently.

Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo cognitive concern screening and, if concerns are endorsed, the 5-Cog battery is conducted

90 days

Multiple visits (in-person)

Follow-up

Participants are monitored for new cognitive impairment diagnoses and improved dementia care

90 days

Follow-up assessments (in-person or virtual)

Implementation and Cost-effectiveness Analysis

Examine implementation issues and cost-effectiveness of the 5-Cog paradigm

What Are the Treatments Tested in This Trial?

Interventions

• 5-Cog Paradigm
• Enhanced usual care

Trial Overview The study compares a new brief cognitive assessment called the 5-Cog Paradigm, which is quick and culturally sensitive, against enhanced usual care to see if it better detects new cases of mild cognitive impairment and dementia in primary care settings.

How Is the Trial Designed?

Group I: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) Experimental Treatment 1 Intervention

A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. If cognitive concerns are endorsed the 5-Cog battery will be conducted. The simple, \<5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. Depending on whether the 5-Cog results are normal or abnormal on any one of the 3 tests, appropriate clinical decision support tools are provided to the primary care physicians in electronic medical record. The primary care physicians are not instructed to follow 5-Cog suggestions verbatim but use their clinical judgment.

Group II: Enhanced usual care Active Control 1 Intervention

Educational sessions for primary care physicians and clinic staff regarding cognitive detection and medical billing will be conducted. A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. The results will be provided to primary care physicians.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

The Chinese version of the ADAS-Cog, designed with pictures for better accessibility, demonstrated high reliability and consistency, making it a suitable tool for assessing cognitive function in individuals with varying levels of dementia.

This assessment tool effectively detects early signs of dementia through memory items and monitors disease progression using language items, proving its utility in clinical settings for Chinese Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Alzheimer's Disease Assessment Scale: findings from a low-education population. Liu, HC., Teng, EL., Chuang, YY., et al.[2019]

Free-Cog is a new screening tool for dementia that effectively assesses both cognitive and functional abilities, showing high sensitivity and specificity for diagnosing dementia in a study of 141 patients.

While Free-Cog is more specific than the Mini-Addenbrooke's Cognitive Examination (MACE) for dementia diagnosis, it is less sensitive for identifying mild cognitive impairment (MCI), suggesting that MACE may be better for detecting MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free-Cog: Pragmatic Test Accuracy Study and Comparison with Mini-Addenbrooke's Cognitive Examination. Larner, AJ.[2020]

The ADAS-Cog assessment tool effectively differentiates between healthy individuals, those with Mild Cognitive Impairment (MCI), and Alzheimer's Disease (AD) in a study of 650 participants, showing significant score differences among the groups.

Optimal cut-off points for diagnosing MCI and AD were established, with the ADAS-Cog showing high specificity for AD (98%) but lower sensitivity for MCI (58%), indicating it is more reliable for identifying advanced cognitive decline rather than early impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation study of the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) for the Portuguese patients with mild cognitive impairment and Alzheimer's disease. Nogueira, J., Freitas, S., Duro, D., et al.[2019]

The Hebrew version of the CAMCOG cognitive test demonstrated good to excellent reliability in distinguishing between dementia sufferers and non-demented elderly individuals, based on a study of 36 dementia patients and 19 control subjects.

The CAMCOG showed strong convergent validity with the MMSE score, indicating it is a reliable tool for assessing cognitive function in a clinical setting, although further research is needed to enhance its discriminatory power across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cambridge Cognitive Examination (CAMCOG): validation of the Hebrew version in elderly demented patients. Heinik, J., Werner, P., Mendel, A., et al.[2004]

The ADAS-Cog is the most commonly used cognitive assessment tool in dementia trials, but it has limitations as it does not evaluate attention, executive function, or agnosia, making it less suitable for non-Alzheimer's dementias.

There is a need for more tailored cognitive assessment tools for different types of dementia, such as frontotemporal dementia, as existing tools like the ADAS-Cog may not adequately capture the cognitive deficits present in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Target symptoms and outcome measures: cognition. Kirk, A.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9245592/

The 5-Cog paradigm to improve detection of cognitive ... The 5-Cog paradigm will achieve 'improved dementia care', helping PCPs make earlier, more consistent diagnoses and institute appropriate ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05515224

Study Details | NCT05515224 | 5-Cog 2.0: A Pragmatic ... Interim analysis revealed that the 5-Cog paradigm resulted in an over 8-fold increase in new cognitive impairment diagnoses and over 3-fold increase in improved ...

3. researchprotocols.org researchprotocols.org/2025/1/e60471

Improving Early Dementia Detection Among Diverse Older ... We will analyze the effectiveness of the 5-Cog paradigm to increase the rate of new diagnoses of mild cognitive impairment syndrome or dementia ...

4. nature.com nature.com/articles/s41591-024-03012-8

Non-literacy biased, culturally fair cognitive detection tool ... The 5-Cog paradigm helped to improve dementia care actions related to diagnosis, investigations and treatments that account for many ...

5. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/46c3b0758815a609ffd56c463daef8c4/napa-august-2024-verghese.pdf

5-Cog Paradigm • 5-Cog paradigm = 5-Cog Battery + 5-Cog recommendations. • 5-Cog is not the best test ever! • Goal is to improve dementia care. The 5-Cog ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03816644

5-Cog Battery for Detecting Cognitive Impairment and ... The 5-Cog includes the Picture Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and the Symbol Match test. The 5-Cog will be given after ...