MyCog for Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Disqualifiers: Children, Adolescence, Younger adults
No Placebo Group
Approved in 1 Jurisdiction
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.
12345What 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.
678910How 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.
1251112Eligibility 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
+3 more
Exclusion Criteria
I am not a child, adolescent, or young adult excluded due to cognitive reasons.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: MyCog ParadigmExperimental Treatment1 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 ArmActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oak Street HealthChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
Oak Street HealthCollaborator
University of Illinois at ChicagoCollaborator
References
The Cambridge Cognitive Examination (CAMCOG): validation of the Hebrew version in elderly demented patients. [2004]The CAMCOG is the second most popular cognitive testing instrument in use by Israeli clinicians. The present study examines the reliability and validity of a Hebrew version of the CAMCOG in a group of dementia sufferers in a clinical setting.
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]Early identification of cognitive impairment (CI), including Alzheimer's disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings.
The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. [2022]The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) has developed brief, comprehensive, and reliable batteries of clinical and neuropsychological tests for assessment of patients with the clinical diagnosis of Alzheimer's disease (AD). We administered these batteries in a standardized manner to more than 350 subjects with a diagnosis of AD and 275 control subjects who were enrolled in a nationwide registry by a consortium of 16 university medical centers. The tests selected for this study measured the primary cognitive manifestations of AD across a range of severity of the disorder, and discriminated between normal subjects and those with mild and moderate dementia. The batteries also detected deterioration of language, memory, praxis, and general intellectual status in subjects returning for reassessment 1 year later. Interrater and test-retest reliabilities were substantial. Long-term observations of this cohort are in progress in an effort to validate the clinical and neuropsychological assessments and to confirm the diagnosis by postmortem examinations. Although information on validation is limited thus far, the CERAD batteries appear to fill a need for a standardized, easily administered, and reliable instrument for evaluating persons with AD in multicenter research studies as well as in clinical practice.
Validation of a new symptom impact questionnaire for mild to moderate cognitive impairment. [2022]Patient-reported outcomes assessment enhances the understanding of disease impact in a range of disorders. At mild levels of cognitive impairment the patient perspective on functioning, behavior and symptoms can be particularly valuable for syndrome characterization when clinical and neuropsychological findings are limited. We have evaluated the psychometric performance of the 55-item Patient-Reported Outcomes in Cognitive Impairment (PROCOG), a new patient-reported measure, to measure mild to moderate cognitive impairment symptoms and their impact from the perspective of patients with dementia of the Alzheimer's type (DAT) and mild cognitive impairment (MCI).
MicroCog: assessment of cognitive functioning. [2022]MicroCog: Assessment of Cognitive Functioning version 2.1 (Powell, D. H., Kaplan, E. F., Whitla, D., Catlin, R., and Funkenstein, H. H. (1993). The Psychological corporation, San Antonio, TX.) is one of the first computerized assessment batteries commercially developed to detect early signs of cognitive impairment. This paper reviews its psychometric characteristics and relates them to its clinical utility. It concludes that MicroCog provides an accurate, cost-effective screen for early dementia among elderly subjects living in the community and that it can distinguish dementia from depression. Its ability to detect cognitive decline at other ages or to discriminate dementia from other mental disorders has not been established. MicroCog measures different constructs than do traditional neuropsychological tests, making it difficult to relate test performance to current models of cognitive functioning. The review recommends further development of MicroCog and discusses its implications for the future of computer-based neuropsychological assessment.
Cognition enhancers in age-related cognitive decline. [2018]A review of recently published studies on the effect of cognition enhancers in non-demented human study participants is presented. The heterogeneity of the therapeutic target, age-associated cognitive decline, can be improved by separately treating groups in whom age-extrinsic factors may underlie cognitive pathology. Standardisation of cognitive assessments is necessary, since many different tests are applied to answer the same question. Modelling cognitive dysfunction, either by pharmacological or nonpharmacological means, in humans is highly recommended since it allows hypotheses to be tested in a clearly operationalised way. Predictive validity of the currently applied models for the clinical situation remains a problem, however. The scopolamine (hyoscine) model has, to a reasonable extent, predictive validity for the cholinergic agents. The results of 67 single-dose studies and 30 multiple-dose studies are summarised. All single-dose studies and 14 multiple-dose studies were carried out in young or elderly human volunteers. In 45 of 81 volunteer studies, models of cognitive dysfunction were employed. The scopolamine model was the most used (n = 21); the other studies induced cognitive dysfunction by means of benzodiazepines (8), hypoxia (7), alcohol (5) and sleep-deprivation (4). The remaining 16 multiple-dose studies were clinical trials of a duration varying between 2 weeks and 1 year (average duration was 14 weeks). In these trials, the effects of cognition enhancers were assessed in elderly people in whom impairment of memory, psychomotor performance or cognitive function was determined. These included age-associated memory impairment (AAMI) and age-associated cognitive decline (AACD). There were many studies in which the cognition enhancing properties of substances in humans were reliably demonstrated. The cognition enhancing properties of substances that are widely used, such as caffeine, nicotine and vitamins, may already be active against AACD. New developments such as serotonin (5-hydroxytryptamine3; 5-HT3) antagonists and N-methyl-D-aspartate (NMDA) antagonists have provided marginal and disappointing results in AAMI. There is no cognition enhancer that has reliably and repeatedly been demonstrated to be efficacious for the treatment of AACD. However, this situation may change as the selectivity, specificity and adverse effect profiles of substances that are being developed for the treatment of AD may be expected to be improved in the future.
Efficacy and safety of BMY 21,502 in Alzheimer disease. [2017]To assess the efficacy and safety of BMY 21,502, a nootropic agent, in patients with mild-to-moderate Alzheimer disease.
The basics of preclinical drug development for neurodegenerative disease indications. [2021]Preclinical development encompasses the activities that link drug discovery in the laboratory to initiation of human clinical trials. Preclinical studies can be designed to identify a lead candidate from several hits; develop the best procedure for new drug scale-up; select the best formulation; determine the route, frequency, and duration of exposure; and ultimately support the intended clinical trial design. The details of each preclinical development package can vary, but all have some common features. Rodent and nonrodent mammalian models are used to delineate the pharmacokinetic profile and general safety, as well as to identify toxicity patterns. One or more species may be used to determine the drug's mean residence time in the body, which depends on inherent absorption, distribution, metabolism, and excretion properties. For drugs intended to treat Alzheimer's disease or other brain-targeted diseases, the ability of a drug to cross the blood brain barrier may be a key issue. Toxicology and safety studies identify potential target organs for adverse effects and define the Therapeutic Index to set the initial starting doses in clinical trials. Pivotal preclinical safety studies generally require regulatory oversight as defined by US Food and Drug Administration (FDA) Good Laboratory Practices and international guidelines, including the International Conference on Harmonization. Concurrent preclinical development activities include developing the Clinical Plan and preparing the new drug product, including the associated documentation to meet stringent FDA Good Manufacturing Practices regulatory guidelines. A wide range of commercial and government contract options are available for investigators seeking to advance their candidate(s). Government programs such as the Small Business Innovative Research and Small Business Technology Transfer grants and the National Institutes of Health Rapid Access to Interventional Development Pilot Program provide funding and services to assist applicants in preparing the preclinical programs and documentation for their drugs. Increasingly, private foundations are also funding preclinical work. Close interaction with the FDA, including a meeting to prepare for submission of an Investigational New Drug application, is critical to ensure that the preclinical development package properly supports the planned phase I clinical trial.
The "rights" of precision drug development for Alzheimer's disease. [2023]There is a high rate of failure in Alzheimer's disease (AD) drug development with 99% of trials showing no drug-placebo difference. This low rate of success delays new treatments for patients and discourages investment in AD drug development. Studies across drug development programs in multiple disorders have identified important strategies for decreasing the risk and increasing the likelihood of success in drug development programs. These experiences provide guidance for the optimization of AD drug development. The "rights" of AD drug development include the right target, right drug, right biomarker, right participant, and right trial. The right target identifies the appropriate biologic process for an AD therapeutic intervention. The right drug must have well-understood pharmacokinetic and pharmacodynamic features, ability to penetrate the blood-brain barrier, efficacy demonstrated in animals, maximum tolerated dose established in phase I, and acceptable toxicity. The right biomarkers include participant selection biomarkers, target engagement biomarkers, biomarkers supportive of disease modification, and biomarkers for side effect monitoring. The right participant hinges on the identification of the phase of AD (preclinical, prodromal, dementia). Severity of disease and drug mechanism both have a role in defining the right participant. The right trial is a well-conducted trial with appropriate clinical and biomarker outcomes collected over an appropriate period of time, powered to detect a clinically meaningful drug-placebo difference, and anticipating variability introduced by globalization. We lack understanding of some critical aspects of disease biology and drug action that may affect the success of development programs even when the "rights" are adhered to. Attention to disciplined drug development will increase the likelihood of success, decrease the risks associated with AD drug development, enhance the ability to attract investment, and make it more likely that new therapies will become available to those with or vulnerable to the emergence of AD.
The value of assessing cognitive function in drug development. [2023]This paper reviews the value and utility of measuring cognitive function in the development of new medicines by reference to the most widely used automated system in clinical research. Evidence is presented from phase 1 to 3 of the nature and quality of the information that can be obtained by applying the Cognitive Drug Research computerized assessment system to ongoing clinical trials. Valuable evidence can be obtained even in the first trial in which a novel compound is administered to man. One application of such testing is to ensure that novel compounds are relatively free from cognition-impairing properties, particularly in relation to competitor products. Another is to ensure that unwanted interactions with alcohol and other medications do not occur, or, if they do, to put them in context. In many patient populations, cognitive dysfunction occurs as a result of the disease process, and newer medicines which can treat the symptoms of the disease without further impairing function can often reveal benefits as the disease-induced cognitive dysfunction is reduced. Another major application is to identify benefits for compounds designed to enhance cognitive function. Such effects can be sought in typical phase 1 trials, or a scopolamine model of the core deficits of Alzheimer's disease can be used to screen potential antidernentia drugs. Ultimately, of course, such effects can be demonstrated using properly validated and highly sensitive automated procedures in the target populations. The data presented demonstrate that the concept of independently assessing a variety of cognitive functions is crucial in helping differentiate drugs, types of dementia, and different illnesses. Such information offers a unique insight into how the alterations to various cognitive functions will manifest themselves in everyday behavior. This reveals a major limitation of scales that yield a single score, because such limited information does not permit anything but a quantitative interpretation; and the concept of "more" cognitive function or "less" is manifestly inappropriate for something as complex and diverse as the interplay between cognitive function and human behavior. Finally, the next generations of cognitive testing are described. Testing via the telephone has just been introduced and will have dramatic effects on the logistics of conducting cognitive testing in large patient trials. Testing via the Internet is not far off either, and will come fully into play as the proportion of homes connected to the Internet increases in Europe and North America. There are no sound reasons for not wishing to include cognitive function testing in the development protocol of any novel medicine.
Computerized Neurocognitive Test (CNT) in mild cognitive impairment and Alzheimer's disease. [2020]Currently, computerized batteries are of great value in detecting cognitive impairment. This aim of this review was to compare the computerized neurocognitive batteries used in most studies with cognitive decline over the last 10 years. Using the search words computerized cognitive assessment with: dementia, mild cognitive impairment, and Alzheimer's disease, the CogState, CNS Vital Sings, COGDRAS and Mindstreams batteries were retrieved.
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]To create a reduced and briefer version of the widely used Cambridge Cognitive Examination (CAMCog) battery as a concise cognitive test to be used in primary and secondary levels of health care to detect cognitive decline. Our aim was to reduce the administration time of the original test while maintaining its diagnostic accuracy.