45257 Participants Needed

MyCog for Cognitive Impairment

MS
MR
Overseen ByMorgan R Bonham, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Our study intends to offer 'real world' evidence of a viable, sustainable means to mobilize primary care via a comprehensive strategy for detecting cognitive impairment and dementias, advancing next steps for referral, and participating in the care planning and management of affected patients and caregivers. We will conduct a clinic-randomized, pragmatic trial testing the effectiveness and fidelity of our NIH Toolbox-derived paradigm to improve early detection and management of cognitive impairment/dementia in primary care settings serving health disparate patient populations.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data exists for MyCog or similar treatments for cognitive impairment?

The research does not provide specific safety data for MyCog or similar treatments for cognitive impairment.12345

How is the MyCog treatment different from other treatments for cognitive impairment?

MyCog is unique because it is an iPad-based, self-administered cognitive assessment tool designed to detect cognitive impairment in diverse primary care settings. Unlike traditional tests, it uses technology to provide a validated assessment and includes decision-support tools for clinicians, making it more accessible and tailored for early detection in underserved communities.678910

What data supports the effectiveness of the treatment MyCog for cognitive impairment?

The MyCog paradigm, which includes the NIH Toolbox Cognition Battery, is designed to detect cognitive impairment and Alzheimer's disease in diverse primary care settings. It is based on validated cognitive assessments and is tailored for early identification of cognitive issues, which is crucial for effective management.7891112

Are You a Good Fit for This Trial?

The MyCog trial is for individuals who have visited an Oak Street healthcare provider at one of the 24 participating practices, had a clinic visit in the last 3 years, and have not been previously diagnosed with cognitive deficits or dementias.

Inclusion Criteria

Had at least one clinic visit (routine or Annual Wellness Visit) during the 3-year study period
Not been diagnosed previously with cognitive deficits, impairments or dementias.
Been seen by an Oak Street healthcare provider affiliated with one of the 24 enrolled practices
See 3 more

Exclusion Criteria

I am not a child, adolescent, or young adult excluded due to cognitive reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation of MyCog Paradigm

Participants undergo cognitive assessment using the MyCog paradigm, which includes self-administered tests linked to electronic health records.

3 years
Regular visits as per primary care schedule

Follow-up

Participants are monitored for cognitive impairment detection rates, referrals, and caregiver involvement.

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • MyCog
Trial Overview This study tests a new approach using health technologies to detect early signs of cognitive impairment and dementia in primary care settings. It's a practical trial that randomly assigns clinics to use this NIH Toolbox-derived method.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: MyCog ParadigmExperimental Treatment1 Intervention
Group II: Usual Care ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Oak Street Health

Collaborator

Trials
1
Recruited
45,300+

University of Illinois at Chicago

Collaborator

Trials
653
Recruited
1,574,000+

Published Research Related to This Trial

The Hebrew version of the CAMCOG cognitive test demonstrated good to excellent reliability in distinguishing between dementia sufferers and non-demented elderly individuals, based on a study of 36 dementia patients and 19 control subjects.
The CAMCOG showed strong convergent validity with the MMSE score, indicating it is a reliable tool for assessing cognitive function in a clinical setting, although further research is needed to enhance its discriminatory power across diverse populations.
The Cambridge Cognitive Examination (CAMCOG): validation of the Hebrew version in elderly demented patients.Heinik, J., Werner, P., Mendel, A., et al.[2004]
The MyCog paradigm is an iPad-based cognitive assessment tool designed to improve the early detection of cognitive impairment and Alzheimer's disease in diverse primary care settings, specifically targeting low socioeconomic, Black, and Hispanic older adults.
This study will involve 24 primary care practices and over 45,000 patients over a 3-year period, comparing the effectiveness of the MyCog intervention against usual care in identifying cognitive deficits and improving care planning for dementia.
Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm.Lovett, R., Bonham, M., Yoshino Benavente, J., et al.[2023]
The CERAD batteries of clinical and neuropsychological tests were administered to over 350 Alzheimer's disease (AD) patients and 275 control subjects, demonstrating substantial reliability in assessing cognitive decline associated with AD.
These tests effectively distinguished between normal cognitive function and varying severities of dementia, and they were able to track cognitive deterioration over a year, indicating their potential utility in both research and clinical settings.
The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease.Morris, JC., Heyman, A., Mohs, RC., et al.[2022]

Citations

The Cambridge Cognitive Examination (CAMCOG): validation of the Hebrew version in elderly demented patients. [2004]
Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm. [2023]
The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. [2022]
Validation of a new symptom impact questionnaire for mild to moderate cognitive impairment. [2022]
MicroCog: assessment of cognitive functioning. [2022]
Cognition enhancers in age-related cognitive decline. [2018]
Efficacy and safety of BMY 21,502 in Alzheimer disease. [2017]
The basics of preclinical drug development for neurodegenerative disease indications. [2021]
The "rights" of precision drug development for Alzheimer's disease. [2023]
The value of assessing cognitive function in drug development. [2023]
Computerized Neurocognitive Test (CNT) in mild cognitive impairment and Alzheimer's disease. [2020]
Sensitivity and specificity of a briefer version of the Cambridge Cognitive Examination (CAMCog-Short) in the detection of cognitive decline in the elderly: An exploratory study. [2019]
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