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NCT05515224 · ClinicalTrials.gov registry record · NA

5-Cog 2.0: A Pragmatic Clinical Trial

A NA study of Dementia and Cognitive Impairment, sponsored by Albert Einstein College of Medicine.

Recruiting
Registry status
NA
Development phase
6,600
Enrollment target
2
Study locations

NCT05515224 is a NA study of Dementia and Cognitive Impairment that is actively recruiting participants, run by Albert Einstein College of Medicine. The registered enrollment target is 6,600 participants, below the 7,690-participant average among 199 other Dementia trials with a reported enrollment target (14% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05515224, a NA study of Dementia and Cognitive Impairment, is actively recruiting participants, sponsored by Albert Einstein College of Medicine.

RECRUITING
Registry status
NA
Development phase
6,600 participants
Enrollment target
2
Study locations

Study 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.

Interventions

  • OTHER Enhanced usual care
  • OTHER 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

Study Locations (2)

Indiana

  • Indiana University - Bloomington

New York

  • Albert Einstein College of Medicine - The Bronx

Trial Details

FieldValue
Enrollment Target 6,600 participants
Start Date 2023-08-18
Est. Completion 2027-11
Phase NA

Sponsor

Albert Einstein College of Medicine

175 total trials

What the Registry Record Tells You About NCT05515224

The ClinicalTrials.gov registry entry for NCT05515224 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 6,600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,690-participant average among 199 other Dementia trials with a reported enrollment target (14% lower). The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 2 interventions - of which Enhanced usual care is the first listed.

NCT05515224 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Indiana, New York.

Frequently Asked Questions

What is clinical trial NCT05515224 about?

NCT05515224 is a clinical study titled "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...

What is the current status of trial NCT05515224?

This trial is currently recruiting. It is a NA study. The enrollment target is 6,600 participants. The study started on 2023-08-18. Estimated completion is 2027-11.

What conditions does trial NCT05515224 study?

This clinical trial studies the following conditions: Dementia, Cognitive Impairment.

What interventions are being tested in trial NCT05515224?

The interventions under investigation include: Enhanced usual care (OTHER), 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) (OTHER).

Who is sponsoring clinical trial NCT05515224?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05515224 being conducted?

This trial has 2 study locations across Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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