Clinical trial NCT03816644: 5-Cog Battery for Detecting Cognitive Impairment and Dementia
Official title: 5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Cognitive Impairment
Mild Cognitive Impairment
Neurocognitive Disorders
Keywords: Cognitive screening
Primary care
Dementia
Cognitive Impairment
Mild Cognitive Impairment
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-01-25
Enrollment: 1201
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Age 65 and older.
2. Presence of cognitive or memory concerns expressed by patient, caregiver, health care provider or other source who knows the patient.
3. Registered as patient at Montefiore Medical Center and have a primary care doctor appointment that day.
4. Able to hear and see well enough to complete intervention or control assessments.
5. English or Spanish speaking.

Exclusion Criteria:

1. 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:

   1. "Dementia"
   2. "Mild Cognitive Impairment"
   3. "Alzheimer's Disease"
   4. "Creutzfeldt-Jakob Disease"
   5. "Major Neurocognitive Disorder"
   6. "Minor Neurocognitive Disorder"

   Patients with any of the following medications documented in their EMR will be excluded (generic = brand):
   1. Donepezil = Aricept
   2. Memantine = Namenda
   3. Rivastigmine = Exelon
   4. Galantamine = Razadyne
   5. Donepezil and Memantine = Namzaric
2. Adults who are permanent residents of a nursing facility.
3. Patients who do not speak English or Spanish.
4. Patients who are not seeing a primary care physician at the clinic that day.
5. Patients who are blind or deaf or cannot hear loud voice even with hearing aids.

Primary outcomes:
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.
timeFrame: 90 days after the participant is randomized
Secondary outcomes:
measure: New Occurrence of in Health Care Utilization
timeFrame: 6 months after the participant is randomized
Other outcomes:
measure: Cost-effectiveness
timeFrame: 6 months after the participant is randomized
measure: Change in Health Care Utilization
timeFrame: 12 months after the participant is randomized
measure: Cost-effectiveness
timeFrame: 12 months after the participant is randomized
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Joe Verghese, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chalmer 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.