5-Cog 2.0: A Pragmatic Clinical Trial

NCT05515224 | Recruiting DMC

• 2 other identifiers: 2022-141442U01NS105565-07
• Study Type: interventional
• Target: 6,600
• Locations: 1 country
• Sites: 2

Brief Summary

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

Dementia; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• New cognitive impairment diagnoses in the 90-day period following presentation of cognitive concern to the primary care physician (PCP).

  The clinical effectiveness of the 5-Cog paradigm on new cognitive impairment detection will be examined by comparing the proportion of 'new Mild Cognitive Impairment (MCI) and dementia diagnoses' over 90-days in the 5-cog paradigm and the enhanced usual care group using generalized linear mixed effects models. For patients with a previous diagnosis of MCI in the electronic medical record, only a new diagnosis of dementia will be considered as an incident outcome.

  Up to 90 days

Secondary Outcomes (1)

• Improved dementia care in the 90-day period following presentation of cognitive concern to the primary care provider (PCP).

  Up to 90 days

Study Arms (2)

5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

EXPERIMENTAL

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.

Other: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

Enhanced usual care

ACTIVE COMPARATOR

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.

Other: Enhanced usual care

Interventions

Enhanced usual care OTHER

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.

Enhanced usual care

5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) OTHER

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 5-Cog battery includes the Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. The simple, \<5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation.

5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years and older
• Presence of cognitive concerns
• English or Spanish speaking.
• Able to see and hear well enough to complete assessments.

You may not qualify if:

• Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians).
• Permanent nursing facility residents.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Indiana University: collaborator
• Northwestern University: collaborator
• Stony Brook University: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (2)

• Chalmer R, Ayers E, Weiss E, Fowler N, Telzak A, Summanwar D, Zwerling J, Wang C, Xu H, Holden R, Fiori K, French D, Nsubayi C, Ansari A, Dexter P, Higbie A, Yadav P, Walker J, Congivaram H, Adhikari D, Melecio-Vazquez M, Boustani M, Verghese J Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial JMIR Res Protoc 2025;14:e60471

  RESULT

• Chalmer RBR, Ayers E, Weiss EF, Fowler NR, Telzak A, Summanwar D, Zwerling J, Wang C, Xu H, Holden RJ, Fiori K, French DD, Nsubayi C, Ansari A, Dexter P, Higbie A, Yadav P, Walker JM, Congivaram H, Adhikari D, Melecio-Vazquez M, Boustani M, Verghese J. Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial. JMIR Res Protoc. 2025 Apr 3;14:e60471. doi: 10.2196/60471.

  PMID: 40179383 DERIVED

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Joe Verghese, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

• Malaz Boustani, MD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

• Erica Weiss, PhD

  Albert Einstein College of Medicie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmeline Ayers, MPH

CONTACT

718-430-3835; emmeline.ayers@einsteinmed.edu

Erica Weiss, PhD

CONTACT

EWEISS@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: August 18, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 1 year of study completion.
• Access Criteria: Data access requests will be reviewed by the PI and Steering Committee. Requestors will be required to sign a Data Access Agreement.

Locations

US (2)