DementiaNCT05515224
5-Cog 2.0: A Pragmatic Clinical Trial
A study testing 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) in people with Dementia and Cognitive Impairment, run by Albert Einstein College of Medicine at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment
- What is being tested?
- 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,600 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Aug 2023to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years and older
- Presence of cognitive concerns
- English or Spanish speaking.
- Able to see and hear well enough to complete assessments.
Who cannot join
- Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians).
- Permanent nursing facility residents.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Erica Weiss, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Indiana University
Bloomington, Indiana, 47405
Malaz Boustani, MD, MPH
Malaz Boustani, MD, MPH
- Recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10461
Erica Weiss, PhD, EWEISS@montefiore.org
Erica Weiss, PhD
About this study
Official title: 5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: 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 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.
Read the detailed description
Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings despite the increasing rates of patient cognitive complaints and the availability of numerous cognitive assessment tools. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. This problem is more prevalent among older African-Americans and Hispanics than older whites, and more common in rural than urban 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 are conducting a simple randomized clinical trial to examine the clinical efficacy of the 5-Cog paradigm (5-Cog brief cognitive assessment paired with a clinical decision-making tool) to improve dementia care in 1,200 predominantly minority sample of older adults with cognitive concerns presenting to a primary care clinic in the Bronx. Interim analysis revealed that the 5-Cog paradigm resulted in an over 8-fold increase in new cognitive impairment diagnoses and over 3-fold increase in improved dementia care actions by primary care physicians compared to an active control arm. Following up on these very promising results, 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 aim of the pragmatic cluster-randomized trial is to test the clinical effectiveness of the 5-Cog paradigm in increasing cognitive impairment detection and improving dementia care - ascertained via electronic medical record. Randomization will be at the clinic level, and select 22 primary care practices; 6 in Bronx and 18 in urban and rural Indiana. 300 participants per practice will be enrolled for a total of 6,600 older patients with cognitive concerns. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations.
Outcomes are new cognitive impairment diagnoses (primary) and improved dementia care (secondary) in the 90-day period following presentation of cognitive concern to the primary care physician.
- New cognitive impairment diagnoses (primary): New diagnosis of dementia or Mild Cognitive Impairment by primary care physicians. For patients with a previous diagnosis of Mild Cognitive Impairment in electronic medical record, only a new diagnosis of dementia will be considered as an incident outcome.
- Improved dementia care (secondary): Any of the following: 1. Tests ordered for reversible causes of cognitive impairment as per published guidelines. 2. New cognitive enhancing medication prescriptions or deprescribing anti-cholinergic. 3. Referral for cognitive/dementia evaluation by specialists (Neurology, Geriatrics, Psychiatry). 4. Referral to social worker or community-based organizations.
Implementation issues and cost-effectiveness of the 5-Cog paradigm will also be examined.
This proposed study focuses on scalable approaches to address the unmet need of early detection of incident cognitive impairment, including in populations that experience health disparities.
- Conditions
- Dementia, Cognitive Impairment
- Being tested
- 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool), Enhanced usual care
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Enhanced usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
The clinical effectiveness of the 5-Cog paradigm on improved dementia care will be examined by comparing the proportion of documentation of improved dementia care in the 5-cog paradigm and the enhanced usual care group using generalized linear mixed effects models. Improved dementia care is defined as any of the following: 1. Tests ordered for reversible causes of cognitive impairment as per published guidelines. 2. New cognitive enhancing medication prescriptions or deprescribing anti-cholinergic. 3. Referral for cognitive/dementia evaluation by specialists (Neurology, Geriatrics, Psychiatry). 4. Referral to social worker or community-based organizations.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start18 Aug 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, National Institute of Neurological Disorders and Stroke (NINDS), Northwestern University, Stony Brook University
- Responsible party
- Sponsor
- Investigators
- Joe Verghese, MD, Principal investigator, Stony Brook UniversityMalaz Boustani, MD, MPH, Principal investigator, Indiana UniversityErica Weiss, PhD, Principal investigator, Albert Einstein College of Medicie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515224
- Sponsor's protocol ID
- 2022-14144
- Other IDs
- 2U01NS105565-07
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available with appropriate ethics committee and data sharing agreements in place.
Publications
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.
PubMed 40179383
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT05515224
- Acronym / sponsor ID
- 2022-14144
- Conditions
- Dementia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,600 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Indiana University, National Institute of Neurological Disorders and Stroke (NINDS), Northwestern University, Stony Brook University
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings despite the increasing rates of patient cognitive complaints and the availability of numerous cognitive assessment tools. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. This problem is more prevalent among older African-Americans and Hispanics than older whites, and more common in rural than urban 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 are conducting a simple randomized clinical trial to examine the clinical efficacy of the 5-Cog paradigm (5-Cog brief cognitive assessment paired with a clinical decision-making tool) to improve dementia care in 1,200 predominantly minority sample of older adults with cognitive concerns presenting to a primary care clinic in the Bronx. Interim analysis revealed that the 5-Cog paradigm resulted in an over 8-fold increase in new cognitive impairment diagnoses and over 3-fold increase in improved dementia care actions by primary care physicians compared to an active control arm. Following up on these very promising results, 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 aim of the pragmatic cluster-randomized trial is to test the clinical effectiveness of the 5-Cog paradigm in increasing cognitive impairment detection and improving dementia care - ascertained via electronic medical record. Randomization will be at the clinic level, and select 22 primary care practices; 6 in Bronx and 18 in urban and rural Indiana. 300 participants per practice will be enrolled for a total of 6,600 older patients with cognitive concerns. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations.
Outcomes are new cognitive impairment diagnoses (primary) and improved dementia care (secondary) in the 90-day period following presentation of cognitive concern to the primary care physician.
- New cognitive impairment diagnoses (primary): New diagnosis of dementia or Mild Cognitive Impairment by primary care physicians. For patients with a previous diagnosis of Mild Cognitive Impairment in electronic medical record, only a new diagnosis of dementia will be considered as an incident outcome.
- Improved dementia care (secondary): Any of the following: 1. Tests ordered for reversible causes of cognitive impairment as per published guidelines. 2. New cognitive enhancing medication prescriptions or deprescribing anti-cholinergic. 3. Referral for cognitive/dementia evaluation by specialists (Neurology, Geriatrics, Psychiatry). 4. Referral to social worker or community-based organizations.
Implementation issues and cost-effectiveness of the 5-Cog paradigm will also be examined.
This proposed study focuses on scalable approaches to address the unmet need of early detection of incident cognitive impairment, including in populations that experience health disparities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) | Experimental | Other: 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. |
| Enhanced usual care | Active comparator | Other: Enhanced usual careEducational 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years and older
- Presence of cognitive concerns
- English or Spanish speaking.
- Able to see and hear well enough to complete assessments.
Key exclusion criteria (2 listed)
- Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians).
- Permanent nursing facility residents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) |
| Enhanced usual careA 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 |
Primary outcome
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
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.
1 secondary outcome
Improved dementia care in the 90-day period following presentation of cognitive concern to the primary care provider (PCP).
Time frame: Up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 40179383Chalmer 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available with appropriate ethics committee and data sharing agreements in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erica Weiss, PhD contact
Joe Verghese, MD principal investigator
Stony Brook University
Malaz Boustani, MD, MPH principal investigator
Indiana University
Erica Weiss, PhD principal investigator
Albert Einstein College of Medicie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) in people with Dementia and Cognitive Impairment, run by Albert Einstein College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmeline Ayers, MPH (718-430-3835, emmeline.ayers@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.