5-Cog Battery for Detecting Cognitive Impairment and Dementia

Dementia Clinical Trial

— 5-Cog  

Official title:

5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816644
• Other study ID #: 2018-9140
• Secondary ID: UG3NS105565
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: March 15, 2023

Study information

• Verified date: December 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of current cognitive screens to improve dementia care in primary care patients with cognitive concerns.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1201
• Est. completion date: March 15, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Mild Cognitive Impairment
• Neurocognitive Disorders

Intervention

Other:
• 5-Cog
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 Assessment
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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness	Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR.	6 months after the participant is randomized
Other	Change in Health Care Utilization	Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.	12 months after the participant is randomized
Other	Cost-effectiveness	Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR.	12 months after the participant is randomized
Primary	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.	90 days after the participant is randomized
Secondary	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.	6 months after the participant is randomized

External Links

•   The Consortium for Detecting Cognitive Impairment, Including Dementia