5-Cog 2.0: A Pragmatic Clinical Trial

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.

NCT Number	NCT05515224
Lead Sponsor	Albert Einstein College of Medicine Collaborators: Indiana University, National Institute of Neurological Disorders and Stroke (NINDS), Northwestern University, Stony Brook University
Conditions	Dementia, Cognitive Impairment
Enrollment	6,600 participants
Start Date	2023-08-18
Primary Completion	2027-11 (estimated)
Study Completion	2027-11 (estimated)
Updated on ClinicalTrials.gov	2026-04-17