Trial of the 5-Cog Assessment to Detect Cognitive Impairment and Improve Dementia Care in Older Adults with Cognitive Concerns in Primary Care
Led by Albert Einstein College of Medicine · Updated on 2026-04-17
6600
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Cognitive impairment related to dementia is often missed in primary care, especially among older adults from minority and socio-economically disadvantaged populations. Researchers are evaluating the 5-Cog brief cognitive assessment, a quick, simple, and standardized tool that takes less than 5 minutes and addresses cultural and logistical barriers. This pragmatic cluster-randomized trial aims to test whether the 5-Cog paradigm improves detection of new cases of cognitive impairment and dementia care in older adults with cognitive concerns.
The study involves 22 primary care clinics in Bronx and Indiana, enrolling about 6,600 patients aged 65 and older who report cognitive concerns. Participants receive either the 5-Cog battery combined with a clinical decision-making tool or enhanced usual care, which includes cognitive concern screening. The 5-Cog battery includes tests like Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. Primary care physicians receive results and decision support but use their clinical judgment in care decisions.
Participants undergo cognitive concern screening before their appointments. Researchers will review new cognitive impairment diagnoses and improvements in dementia care within 90 days after the primary care visit using electronic medical records. Additional evaluations include tests for reversible causes, medication changes, specialist referrals, and social support. The study also examines the 5-Cog paradigms implementation and cost-effectiveness, focusing on populations facing health disparities. Total participation duration varies by patient and clinic schedule.
CONDITIONS
Brief Title
5-Cog 2.0: A Pragmatic Clinical Trial
Research Team
E
Emmeline Ayers, MPH
E
Erica Weiss, PhD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
5‑Cog Paradigm (investigational)
Enhanced Usual Care (trial comparator)
Typical Primary Care Follow‑Up (external context)
What it is
A brief (<5‑minute) cognitive assessment using picture memory, motoric cognitive risk, and symbol matching plus a clinical decision‑support tool delivered in primary care
Cognitive concern screening results provided to primary care physicians without additional decision support
Primary care clinicians typically respond to cognitive concerns using existing brief screening tools (such as Mini‑Cog or MMSE) with no standardized decision‑support pathway
Role in trial
Investigational intervention under study to improve dementia detection and follow‑through
Active comparator arm reflecting enhanced screening information delivery
Represents typical follow‑up practice outside the trial
Primary use
Improve early detection of cognitive impairment and guide clinician response via decision tool
Alert primary care provider to cognitive concerns without structured follow‑up guidance
Identify cognitive concern and rely on clinician judgment for next steps
How it is performed
Administered before primary care visit; delivered via brief cognitive tests plus electronic decision‑support tree
Screening results provided to physician prior to visit without decision‑support elements
Routine brief screening (e.g., Mini‑Cog or MMSE) performed as part of clinical evaluation without structured follow‑up tool
Evidence status
Randomized trial evidence indicates the 5‑Cog Paradigm tripled odds of receiving dementia‑related care actions within 90 days in diverse patients
Used as comparator; trial provides relative assessment but no external evidence of efficacy
Evidence is insufficient to determine benefit of routine screening alone for cognitive impairment in older adults
Important limitations
Test performance and clinician response rely on primary care workflow adoption and EMR integration; long‑term outcomes not yet established
Leaving clinicians without structured follow‑up guidance may perpetuate under‑diagnosis or inconsistent care
Routine screening without structured decision support has insufficient evidence of benefit and may lead to variable clinician response
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
65 years and older
Presence of cognitive concerns
English or Spanish speaking
Able to see and hear well enough to complete assessments
You will not qualify if you...
Prior diagnosis of dementia documented or reported
Permanent nursing facility residents
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to primary care appointment
Treatment
Duration - Up to 90 days following presentation of cognitive concern
Participants undergo cognitive concern screening and, if concerns are endorsed, complete the 5-Cog cognitive assessment or receive enhanced usual care. Primary care physicians receive results and may use clinical decision support tools to guide care.
Assessment occurs prior to primary care appointment; follow-up care as part of routine clinical visits
Follow-up
Duration - Up to 90 days following cognitive concern presentation
Participants are monitored for new cognitive impairment diagnoses and improvements in dementia care based on care actions taken by primary care physicians.
No additional visits; outcomes assessed via electronic medical records
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial.
Rachel Beth Rosansky Chalmer, Emmeline Ayers, Erica F Weiss...