| NCT ID | NCT05515224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert Einstein College of Medicine |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,600 participants |
| Start Date | 2023-08-18 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,600 participants in total. It began in 2023-08-18 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Joe Verghese, MD
PRINCIPAL INVESTIGATOR
Stony Brook University
Frequently Asked Questions
Who can join the NCT05515224 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05515224 currently recruiting?
Yes, NCT05515224 is actively recruiting participants. Contact the research team at emmeline.ayers@einsteinmed.edu for enrollment information.
Where is the NCT05515224 trial being conducted?
This trial is being conducted at Bloomington, United States, The Bronx, United States.
Who is sponsoring the NCT05515224 clinical trial?
NCT05515224 is sponsored by Albert Einstein College of Medicine. The principal investigator is Joe Verghese, MD at Stony Brook University. The trial plans to enroll 6,600 participants.