Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT05515224

5-Cog 2.0: A Pragmatic Clinical Trial

Led by Albert Einstein College of Medicine · Updated on 2026-04-17

6600

Participants Needed

2

Research Sites

219 weeks

Total Duration

On this page

Sponsors

A

Albert Einstein College of Medicine

Lead Sponsor

I

Indiana University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. This problem is more prevalent in health disparities populations. The investigators developed the 5-Cog brief cognitive assessment that is simple to use, standardized, takes \<5 minutes, does not require informants, and accounts for major technical, cultural, and logistical barriers of current assessments. The investigators propose a hybrid Type 1 effectiveness-implementation design in real-world settings to adapt and test the effectiveness of the 5-Cog paradigm to increase detection of cognitive impairment care in older adults presenting with cognitive concerns. The study aim is to evaluate, using a pragmatic cluster-randomized trial design, the effectiveness of the 5-Cog paradigm to increase 'incident cognitive impairment' detection (new MCI and dementia diagnoses) relative to enhanced usual care in 6,600 older patients presenting with cognitive concerns in 22 primary care clinics in Bronx and Indiana. As diagnosis without action will not improve patient care, 'improved dementia care' will be examined as a secondary outcome. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations.

CONDITIONS

Official Title

5-Cog 2.0: A Pragmatic Clinical Trial

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Prior diagnosis of dementia documented in medical records or reported by physicians
  • Permanent residents of nursing facilities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Indiana University

Bloomington, Indiana, United States, 47405

Actively Recruiting

2

Albert Einstein College of Medicine

The Bronx, New York, United States, 10461

Actively Recruiting

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Research Team

E

Emmeline Ayers, MPH

CONTACT

E

Erica Weiss, PhD

CONTACT

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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