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5-Cog 2.0: A Pragmatic Clinical Trial
5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: Pragmatic Clinical Trial
Who can join
Ages 65 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. 65 years and older 2. Presence of cognitive concerns 3. English or Spanish speaking. 4. Able to see and hear well enough to complete assessments. Exclusion Criteria: 1. Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians). 2. Permanent nursing facility residents.
About the study
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.
What is being tested
- 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) (other)
- Enhanced usual care (other)
Sponsor: Albert Einstein College of Medicine · Participants: 6,600 · Started: Aug 18, 2023
Contact the study team
- Emmeline Ayers, MPH · Phone: 718-430-3835
Official record on ClinicalTrials.gov — NCT05515224
Locations in the U.S.
| Indiana | Indiana University, Bloomington |
| New York | Albert Einstein College of Medicine, The Bronx |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.