MyCog for Cognitive Impairment

Overseen By Morgan R Bonham, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Children, Adolescence, Younger adults

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

45257 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 5 11 12}

Eligibility Criteria

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

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: MyCog Paradigm Experimental Treatment 1 Intervention

The MyCog paradigm establishes a protocol for implementing our self-administered assessment in the clinic whenever a patient or involved family member reports a concern. The MyCog test can be completed either in the exam room or the waiting room. The MyCog app, on an iPad, can be readily linked to the electronic health record, so once the two tests are completed, results are securely transmitted and will populate within discrete, fields that can be queried found in the patient record; specifically: 1) in a screening tab, under 'cognitive abilities', 2) a flow sheet to capture trend with future repeated tests - informing physicians of a patient's relative vs. normative cognitive decline. Both a binary, objective classification of 'impairment detected or suspected' or 'no impairment detected' will populate in the record, as well as a summary score to further guide the clinician by clarifying the extent to which a patient's performance falls outside a normal threshold.

Group II: Usual Care Arm Active Control 1 Intervention

At Oak Street Health, cognitive assessments included when concerns are reported by patients or family members, if a clinician suspects a concern, or during Annual Wellness Visits (AWVs) are limited to the Mini-Cog©, and are variably administered, particularly outside of AWVs. Oak Street practices vary by clinician in terms of making referrals, how results are documented, what diagnosis code, placement in problem list or visit diagnosis, and any follow-up plans. While we will not make any explicit recommendations to usual care practices regarding their use of a cognitive assessment, we will ensure that 1) any chosen test is linked to a data field that can be queried in the EHR, and 2) providers receive a compiled list of local medical and non-medical referrals for any detected cases of CI. The Alzheimer's Association recommendations for early detection efforts among primary care practices will be provided to each clinical leadership.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The 55-item Patient-Reported Outcomes in Cognitive Impairment (PROCOG) measure has shown good to excellent psychometric properties in assessing symptoms and impacts of mild to moderate cognitive impairment in patients with dementia of the Alzheimer's type (DAT) and mild cognitive impairment (MCI).

In a study involving 186 participants (75 DAT patients, 78 MCI patients, and 33 cognitively intact controls), PROCOG scores effectively differentiated between cognitive impairment levels and correlated moderately to highly with established quality of life and depression measures, highlighting its utility in capturing the patient perspective on cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a new symptom impact questionnaire for mild to moderate cognitive impairment. Frank, L., Flynn, JA., Kleinman, L., et al.[2022]

MicroCog is an effective and cost-efficient tool for screening early signs of dementia in elderly individuals living in the community, demonstrating its clinical utility in identifying cognitive impairment.

The assessment can differentiate between dementia and depression, but its effectiveness in detecting cognitive decline in younger populations or distinguishing dementia from other mental disorders remains unproven.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MicroCog: assessment of cognitive functioning. Elwood, RW.[2022]

Cognition enhancers like caffeine and nicotine have shown reliable effects in improving age-associated cognitive decline (AACD), but no single cognition enhancer has consistently proven effective for treating AACD across studies.

The review highlights the importance of standardized cognitive assessments and the use of models like scopolamine to better understand cognitive dysfunction, although predictive validity for clinical situations remains a challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognition enhancers in age-related cognitive decline. Riedel, WJ., Jolles, J.[2018]

In a study of 69 patients with mild-to-moderate Alzheimer's disease, BMY 21,502 showed a slight improvement in cognitive scores compared to placebo, particularly in patients with moderate dementia, but these results were not statistically significant.

While BMY 21,502 was generally well tolerated, it was associated with higher rates of abnormal liver enzyme levels and nausea, leading to a higher discontinuation rate among patients compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of BMY 21,502 in Alzheimer disease. Shrotriya, RC., Cutler, NR., Sramek, JJ., et al.[2017]

Preclinical development is essential for transitioning from laboratory drug discovery to human clinical trials, involving safety assessments and pharmacokinetic profiling using rodent and nonrodent models to identify potential toxicity and determine appropriate dosing.

For drugs targeting conditions like Alzheimer's disease, understanding the ability to cross the blood-brain barrier is crucial, and regulatory oversight ensures that preclinical studies meet safety and efficacy standards before advancing to clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The basics of preclinical drug development for neurodegenerative disease indications. Steinmetz, KL., Spack, EG.[2021]

Alzheimer's disease drug development faces a significant challenge, with 99% of trials failing to show a difference between drug and placebo, highlighting the need for improved strategies to enhance success rates.

Key strategies for optimizing Alzheimer's drug development include identifying the right biological target, drug, biomarkers, participants, and trial design, which can help increase the likelihood of successful outcomes and attract investment for new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "rights" of precision drug development for Alzheimer's disease. Cummings, J., Feldman, HH., Scheltens, P.[2023]

Measuring cognitive function using the Cognitive Drug Research computerized assessment system in clinical trials can provide valuable insights from the very first phase of testing, helping to ensure that new medications do not impair cognitive abilities or interact negatively with other substances.

Incorporating cognitive function assessments into drug development is essential, as it allows for a nuanced understanding of how new treatments affect cognitive abilities, which is particularly important for conditions like dementia, and future advancements in testing methods, such as telephone and internet assessments, will enhance the feasibility of these evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of assessing cognitive function in drug development. Wesnes, KA.[2023]

Computerized neurocognitive batteries, such as CogState, CNS Vital Signs, COGDRAS, and Mindstreams, are valuable tools for detecting cognitive impairment in conditions like dementia and Alzheimer's disease.

This review highlights the evolution of these computerized assessments over the last decade, emphasizing their importance in identifying cognitive decline effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Neurocognitive Test (CNT) in mild cognitive impairment and Alzheimer's disease. de Oliveira, MO., Brucki, SMD.[2020]

The CAMCog-Short, a reduced version of the original Cambridge Cognitive Examination, was developed from an analysis of 835 tests across 429 subjects, maintaining high diagnostic accuracy while significantly reducing administration time.

This shorter test effectively differentiates between cognitive decline levels, achieving an area under the ROC curve (AUC) greater than 0.9 for distinguishing dementia from controls and mild cognitive impairment, making it a promising tool for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Radanovic, M., Facco, G., Forlenza, OV.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The Cambridge Cognitive Examination (CAMCOG): validation of the Hebrew version in elderly demented patients. [2004]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Validation of a new symptom impact questionnaire for mild to moderate cognitive impairment. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

MicroCog: assessment of cognitive functioning. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Cognition enhancers in age-related cognitive decline. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of BMY 21,502 in Alzheimer disease. [2017]

8. England pubmed.ncbi.nlm.nih.gov

The basics of preclinical drug development for neurodegenerative disease indications. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The "rights" of precision drug development for Alzheimer's disease. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The value of assessing cognitive function in drug development. [2023]

11. Brazil pubmed.ncbi.nlm.nih.gov

Computerized Neurocognitive Test (CNT) in mild cognitive impairment and Alzheimer's disease. [2020]

12. England pubmed.ncbi.nlm.nih.gov

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]