Dementia5-CogNCT03816644
5-Cog Battery for Detecting Cognitive Impairment and Dementia
A study testing 5-Cog and Health Literacy & Grip Assessment in people with Dementia and Cognitive Impairment, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. The investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the technical, cultural and logistic barriers… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Impairment, Mild Cognitive Impairment
- What is being tested?
- 5-Cog and Health Literacy & Grip Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,201 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 and older.
- Presence of cognitive or memory concerns expressed by patient, caregiver, health care provider or other source who knows the patient.
- Registered as patient at Montefiore Medical Center and have a primary care doctor appointment that day.
- Able to hear and see well enough to complete intervention or control assessments.
- English or Spanish speaking.
Who cannot join
- Prior diagnosis of dementia or MCI as ascertained by ICD-10 codes or the documentation of prescription for anti-dementia medications in EMR. Patients with a diagnosis containing any of the following terms will be excluded:
- "Dementia"
- "Mild Cognitive Impairment"
- "Alzheimer's Disease"
- "Creutzfeldt-Jakob Disease"
- "Major Neurocognitive Disorder"
Show all 17Show fewer
- "Minor Neurocognitive Disorder"
- Patients with any of the following medications documented in their EMR will be excluded (generic = brand):
- Donepezil = Aricept
- Memantine = Namenda
- Rivastigmine = Exelon
- Galantamine = Razadyne
- Donepezil and Memantine = Namzaric
- Adults who are permanent residents of a nursing facility.
- Patients who do not speak English or Spanish.
- Patients who are not seeing a primary care physician at the clinic that day.
- Patients who are blind or deaf or cannot hear loud voice even with hearing aids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: 5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. The investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the technical, cultural and logistic barriers of current cognitive screens to improve dementia care in primary care patients with cognitive concerns.
Read the detailed description
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings, and is a more prevalent problem among older African-Americans and Hispanics than among older whites. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. To overcome the technical, cultural and logistic barriers of current cognitive screens and dementia care in primary care settings the investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to identify persons at high risk of developing dementia in multi-ethnic primary care populations.
The 5-Cog includes the Picture based Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and a brief non-memory picture based test (Symbol Match). The cognitive assessment will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. It is coupled with a decision tree to guide clinicians through the follow up based on results of the 5-Cog.
The primary objective is to test the ability of the 5-Cog and decision tree paradigm to improve dementia care in primary care patients with cognitive concerns.
The investigators propose a single-blind, randomized clinical trial (RCT) in 1,200 older primary care patients with cognitive concerns who will be randomized to receive the 5-Cog (intervention group) or a 5-minute health literacy and grip assessment (active control group). Non-physicians will administer the intervention and control assessments in primary care sites and will provide results for both arms to the treating physician with a decision tree follow up guide based on the results of the assessments.
- Being tested
- 5-Cog, Health Literacy & Grip Assessment
- Keywords
- Cognitive screening, Primary care, Dementia, Cognitive Impairment, Mild Cognitive Impairment
- Medical subject headings
- Dementia, Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-CogOther
The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.
Health Literacy & Grip AssessmentOther
The health literacy and grip assessment will take approximately 5 minutes, and will test the patient's comprehension and pronunciation of health-related terms as well as strength in their dominant hand. The screen will sort out patients with 'low health literacy' and 'frail (low grip strength)' from those with normal health literacy and normal grip strength.
| Study group | Role | What they receive |
|---|---|---|
| 5-Cog | Experimental | The 5-Cog coupled with a decision tree is a simple, 5-minute procedure that will identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. The 5-Cog includes the Picture Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and the Symbol Match test. The 5-Cog will be given after randomization and before the patients sees the physician. The 5-Cog will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. After completing the 5-Cog, the non-physician tester will send a message through the Electronic medical record (EMR) system to provide the physician with the 5-Cog results and guide the them through the follow-up based on the results. Receives: Other: 5-Cog |
| Health Literacy & Grip Assessment | Active comparator | The 5 minute assessment includes the Short Assessment of Health Literacy (SAHL) and a grip assessment measured using a handgrip dynamometer. After completing the SAHL and grip assessment, the non-physician tester will send a message through the EMR to provide the physician with the results from the assessments and guide the them through the follow-up based on the results. Receives: Other: Health Literacy & Grip Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals.
Dementia care is defined as the occurrence of any of the following endpoints following the screening visit. The endpoint is the number of participants who received 1 or more of the following orders:
- Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR.
- Tests ordered for reversible causes of cognitive impairment as recommended by the published guidelines of professional societies (i.e. thyroid function tests, B-12 level, Syphilis Panel, human immunodeficiency virus (HIV) test, computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans) documented in the EMR.
- Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR.
- Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR.
Measured: 90 days after the participant is randomized
Secondary outcomes (1)
New Occurrence of in Health Care Utilization
Utilization is defined in terms of emergency room visits and hospitalizations following the screening visit. The number of participants who went to the emergency room or had a hospitalization in the 6 months following the screening visit are presented in aggregate.
Measured: 6 months after the participant is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start28 May 2019
- Primary completion15 Dec 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe Verghese, MBBS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816644
- Sponsor's protocol ID
- 2018-9140
- Other IDs
- UG3NS105565
- Acronym
- 5-Cog
- Status last verified
- Dec 2023
- First submitted
- 22 Jan 2019
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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.
Publications
Malik R, Weiss EF, Gottesman R, Zwerling J, Verghese J. Picture-Based Memory Impairment Screen: Effective Cognitive Screen in Ethnically Diverse Populations. J Am Geriatr Soc. 2018 Aug;66(8):1598-1602. doi: 10.1111/jgs.15422. Epub 2018 May 29.
PubMed 29808583Verghese J, Chalmer R, Stimmel M, Weiss E, Zwerling J, Malik R, Rasekh D, Ansari A, Corriveau RA, Ehrlich AR, Wang C, Ayers E. Non-literacy biased, culturally fair cognitive detection tool in primary care patients with cognitive concerns: a randomized controlled trial. Nat Med. 2024 Aug;30(8):2356-2361. doi: 10.1038/s41591-024-03012-8. Epub 2024 Jun 4.
PubMed 38834847Chalmer R, Ayers E, Weiss EF, Malik R, Ehrlich A, Wang C, Zwerling J, Ansari A, Possin KL, Verghese J. The 5-Cog paradigm to improve detection of cognitive impairment and dementia: clinical trial protocol. Neurodegener Dis Manag. 2022 Aug;12(4):171-184. doi: 10.2217/nmt-2021-0043. Epub 2022 May 23.
PubMed 35603666
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT03816644
- Acronym / sponsor ID
- 5-Cog / 2018-9140
- Keywords
- Cognitive screening, Primary care, Dementia, Cognitive Impairment, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,201 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. The investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the technical, cultural and logistic barriers of current cognitive screens to improve dementia care in primary care patients with cognitive concerns.
Detailed description
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings, and is a more prevalent problem among older African-Americans and Hispanics than among older whites. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. To overcome the technical, cultural and logistic barriers of current cognitive screens and dementia care in primary care settings the investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to identify persons at high risk of developing dementia in multi-ethnic primary care populations.
The 5-Cog includes the Picture based Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and a brief non-memory picture based test (Symbol Match). The cognitive assessment will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. It is coupled with a decision tree to guide clinicians through the follow up based on results of the 5-Cog.
The primary objective is to test the ability of the 5-Cog and decision tree paradigm to improve dementia care in primary care patients with cognitive concerns.
The investigators propose a single-blind, randomized clinical trial (RCT) in 1,200 older primary care patients with cognitive concerns who will be randomized to receive the 5-Cog (intervention group) or a 5-minute health literacy and grip assessment (active control group). Non-physicians will administer the intervention and control assessments in primary care sites and will provide results for both arms to the treating physician with a decision tree follow up guide based on the results of the assessments.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Cog | Experimental | Other: 5-CogThe 5-Cog coupled with a decision tree is a simple, 5-minute procedure that will identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. The 5-Cog includes the Picture Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and the Symbol Match test. The 5-Cog will be given after randomization and before the patients sees the physician. The 5-Cog will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. After completing the 5-Cog, the non-physician tester will send a message through the Electronic medical record (EMR) system to provide the physician with the 5-Cog results and guide the them through the follow-up based on the results. |
| Health Literacy & Grip Assessment | Active comparator | Other: Health Literacy & Grip AssessmentThe 5 minute assessment includes the Short Assessment of Health Literacy (SAHL) and a grip assessment measured using a handgrip dynamometer. After completing the SAHL and grip assessment, the non-physician tester will send a message through the EMR to provide the physician with the results from the assessments and guide the them through the follow-up based on the results. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 and older.
- Presence of cognitive or memory concerns expressed by patient, caregiver, health care provider or other source who knows the patient.
- Registered as patient at Montefiore Medical Center and have a primary care doctor appointment that day.
- Able to hear and see well enough to complete intervention or control assessments.
- English or Spanish speaking.
Key exclusion criteria (17 listed)
- Prior diagnosis of dementia or MCI as ascertained by ICD-10 codes or the documentation of prescription for anti-dementia medications in EMR. Patients with a diagnosis containing any of the following terms will be excluded:
- Patients with any of the following medications documented in their EMR will be excluded (generic = brand):
- Adults who are permanent residents of a nursing facility.
- Patients who do not speak English or Spanish.
- Patients who are not seeing a primary care physician at the clinic that day.
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-CogThe 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'. | Other | 5-Cog |
| Health Literacy & Grip AssessmentThe health literacy and grip assessment will take approximately 5 minutes, and will test the patient's comprehension and pronunciation of health-related terms as well as strength in their dominant hand. The screen will sort out patients with 'low health literacy' and 'frail (low grip strength)' from those with normal health literacy and normal grip strength. | Other | Health Literacy & Grip Assessment |
Primary outcome
New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals.
Time frame: 90 days after the participant is randomized
Dementia care is defined as the occurrence of any of the following endpoints following the screening visit. The endpoint is the number of participants who received 1 or more of the following orders: 1. Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR. 2. Tests ordered for reversible causes of cognitive impairment as recommended by the published guidelines of professional societies (i.e. thyroid function tests, B-12 level, Syphilis Panel, human immunodeficiency virus (HIV) test, computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans) documented in the EMR. 3. Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR. 4. Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR.
1 secondary outcome
New Occurrence of in Health Care Utilization
Time frame: 6 months after the participant is randomized
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29808583Malik R, Weiss EF, Gottesman R, Zwerling J, Verghese J. Picture-Based Memory Impairment Screen: Effective Cognitive Screen in Ethnically Diverse Populations. J Am Geriatr Soc. 2018 Aug;66(8):1598-1602. doi: 10.1111/jgs.15422. Epub 2018 May 29.
- Derived from this study: PubMed 38834847Verghese J, Chalmer R, Stimmel M, Weiss E, Zwerling J, Malik R, Rasekh D, Ansari A, Corriveau RA, Ehrlich AR, Wang C, Ayers E. Non-literacy biased, culturally fair cognitive detection tool in primary care patients with cognitive concerns: a randomized controlled trial. Nat Med. 2024 Aug;30(8):2356-2361. doi: 10.1038/s41591-024-03012-8. Epub 2024 Jun 4.
- Derived from this study: PubMed 35603666Chalmer R, Ayers E, Weiss EF, Malik R, Ehrlich A, Wang C, Zwerling J, Ansari A, Possin KL, Verghese J. The 5-Cog paradigm to improve detection of cognitive impairment and dementia: clinical trial protocol. Neurodegener Dis Manag. 2022 Aug;12(4):171-184. doi: 10.2217/nmt-2021-0043. Epub 2022 May 23.
- The Consortium for Detecting Cognitive Impairment, Including DementiaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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. This study is not recruiting at the moment.
Joe Verghese, MBBS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Cog and Health Literacy & Grip Assessment in people with Dementia and Cognitive Impairment, run by Albert Einstein College of Medicine at 1 site 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals. (time frame: 90 days after the participant is randomized). 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 NCT03816644, which also lists 3 linked publications.
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 9 Jan 2024.