Recruiting

5-Cog 2.0

Sponsor:

Albert Einstein College of Medicine

Code:

NCT05515224

Conditions

Dementia

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

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

Enhanced usual care

Study Details

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

Study ID

NCT05515224

Start date

Aug 18, 2023

Status verified date

Apr, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

6600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

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.

active comparator: Enhanced usual care

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.

Interventions

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

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.

Enhanced usual care

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.

Primary outcome measure

  • New cognitive impairment diagnoses in the 90-day period following presentation of cognitive concern to the primary care physician (PCP). [ Time Frame: Up to 90 days ]

Central Contacts and Locations

Central contacts

Emmeline Ayers, MPH

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

Erica Weiss, PhD

EWEISS@montefiore.org

Locations

Indiana University

Recruiting

Bloomington, Indiana, United States, 47405

Principal Investigator:

Malaz Boustani, MD, MPH

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

Erica Weiss, PhD

EWEISS@montefiore.org

Principal Investigator:

Erica Weiss, PhD

More Information

Sponsor

Albert Einstein College of Medicine

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Albert Einstein College of Medicine on 2026-04-17.