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5-Cog 2.0: A Pragmatic Clinical Trial
NCT05515224 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 6,600 participants |
| Start Date | 2023-08-18 |
| Est. Completion | 2027-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05515224
The ClinicalTrials.gov registry entry for NCT05515224 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05515224 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Indiana, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05515224?
This trial is sponsored by Albert Einstein College of Medicine, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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