SBIR-STTR Award

Cognitive dysfunction in the elderly population, ranging from simple forgetfulness to a diagnosis of Alzheimer's disease, can impact one's quality of life and ability to function in daily activities. It is crucial that decline be detected as early as possible in order to evaluate whether the cause is treatable, and to employ appropriate treatment, if applicable. The majority of elderly patients rely on their primary care physician for the bulk of their healthcare needs, but there is a lack of sensitive tools available to the physician, and there is a lack of physician's time to use the tools that are available. A hesitancy to diagnose cognitive dysfunction compounds the problem, resulting in a severe under-detection of cognitive decline leading to dementia, and a failure to provide therapeutic intervention at the earliest stages of loss to potentially slow the progression of disease. There is a clear need for an easy-to-use and brief assessment tool designed to target early cognitive decline, and a need to introduce the tool to providers who most frequently care for the elderly population: Primary Care Physicians (PCPs). Psychology Software Tools, Inc. (PST) has developed such a tool, the Computer Assessment of Mild Cognitive Impairment (CAMCI), a computerized screening tool for the detection of early signs of cognitive decline, which has been shown to be more effective in the identification of patients with subtle cognitive loss than the tool most frequently used within the PCP office (i.e., MMSE). With PST's considerable experience in computerized testing and working with elderly populations, and in accordance with PST's company mission to advance the fields of research and assessment, CAMCI would provide an option for PCPs and clinicians to provide therapeutic intervention prior to a diagnosis of dementia. Recent additions to CPT codes permit insurance reimbursement for neuropsychological testing by a computer, including time for the physician's or clinical psychologist's interpretation and reporting. The introduction of this new revenue stream for PCPs and clinicians, coupled with the characteristics of being brief and self-administered make the CAMCI an attractive option for improving early intervention in the progressive condition preceding Alzheimer's disease. Hurdles such as the development of alternate forms, language translations, and effective training materials now exist in the commercialization of this promising tool that would delay or prevent the widespread adoption of the CAMCI. In the current project, we propose to address these barriers to adoption with the ultimate goal of providing a useful and effective tool in the detection of cognitive dysfunction to physicians, the providers of the majority of healthcare to the elderly population.

Public Health Relevance:
Alzheimer's disease (AD) is a significant health problem in the United States, resulting in a cost as much as $100 billion a year. We will provide a solution to Primary Care Physician's that does not impede on their time or budget so that they may identify of mild cognitive impairment (MCI) in the earliest stages so that treatment can be started to delay the transition from MCI to AD. This has the potential to delay the devastating effects of the disease, and also lessen the financial burden on the health care system in the United States.

Public Health Relevance Statement:
Project Narrative Alzheimer's disease (AD) is a significant health problem in the United States, resulting in a cost as much as $100 billion a year. We will provide a solution to Primary Care Physician's that does not impede on their time or budget so that they may identify of mild cognitive impairment (MCI) in the earliest stages so that treatment can be started to delay the transition from MCI to AD. This has the potential to delay the devastating effects of the disease, and also lessen the financial burden on the health care system in the United States.

Project Terms:
Address; Adoption; advanced age; Age; Aged 65 and Over; Alzheimer; Alzheimer disease; Alzheimer sclerosis; Alzheimer syndrome; Alzheimer's; Alzheimer's Disease; Alzheimers Dementia; Alzheimers disease; Amentia; Budgets; Care, Health; Caring; Characteristics; Clinical; Codes, CPT; Cognitive decline; Cognitive Disturbance; cognitive dysfunction; Cognitive function abnormal; Cognitive Impairment; cognitive loss; cognitively impaired; college; commercial application; commercialization; Communities; computer program/software; Computer Programs; Computer software; Computer Software Tools; computerized; Computers; Contracting Opportunities; Contracts; cost; Coupled; Current Procedural Terminology Codes; Dementia; dementia of the Alzheimer type; Dementia, Alzheimer Type; Dementia, Primary Senile Degenerative; Dementia, Senile; design; designing; Detection; Development; Diagnosis; Disease; Disease Progression; disease/disorder; Disorder; Disturbance in cognition; early detection; Early Diagnosis; Early treatment; Elderly; elderly patient; Elderly, over 65; elders; Evaluation; experience; failure; Failure (biologic function); Feedback; FLR; Focus Groups; foreign language; geriatric; Goals; Grant; Health; health care personnel; Health Care Providers; health care worker; Health Personnel; health provider; Healthcare; healthcare personnel; Healthcare Providers; Healthcare Systems; Healthcare worker; HOSP; Hospitals; Impaired cognition; improved; Individual; Industry; Insurance; Intention; Intervention; Intervention Strategies; intervention therapy; interventional strategy; Investigators; Language; late life; later life; Licensing; Market Research; Marketing; medical personnel; meetings; mild cognitive disorder; mild cognitive impairment; mild neurocognitive disorder; Mission; neurophysiology; Neuropsychologic Tests; neuropsychological; Neuropsychological Tests; older adult; older patient; older person; Patients; Physicians; Physicians' Offices; Plant Embryos; Population; prevent; preventing; Primary Care Physician; primary degenerative dementia; Primary Senile Degenerative Dementia; Professional Organizations; PROV; Provider; Psychologist; Psychology; public health relevance; QOL; Qualifying; Quality of life; recruit; Recruitment Activity; Reporting; Research; Research Personnel; Researchers; response; Retirement; Running; Scheme; Science of neurophysiology; screening; Screening procedure; screenings; seed; Seeds; Self-Administered; senile dementia of the Alzheimer type; senior citizen; Services; Site; Software; Software Tools; Solutions; Staging; Stream; System; System, LOINC Axis 4; Systems, Health Care; Testing; Therapeutic Intervention; Time; tool; Tools, Software; Training; Translations; treatment provider; United States; Universities; usability; Validation; Work; Zygotes, Plant

Cognitive dysfunction in the elderly population, ranging from simple forgetfulness to a diagnosis of Alzheimer’s disease, can impact one’s quality of life and ability to function in daily activities. It is crucial that decline be detected as early as possible in order to evaluate whether the cause is treatable, and to employ appropriate treatment, if applicable. The majority of older patients rely on their primary care physician for the bulk of their healthcare needs, but there is a lack of sensitive tools available to the physician, and there is a lack of physician’s time to use the tools that are available, leading to a failure to provide therapeutic intervention at the earliest stages of loss to potentially slow the progression of disease. There is a clear need for an easy-to-use and brief assessment tool designed to target early cognitive decline, and a need to introduce the tool to providers who most frequently care for the elderly population: Primary Care Physicians (PCPs). Psychology Software Tools, Inc. (PST) has developed such a tool, the Computer Assessment of Memory and Cognitive Impairment (CAMCI), a computerized screening tool for the detection of early signs of cognitive decline, which has been shown to be more effective in the identification of patients with subtle cognitive loss than the tool most frequently used within the PCP office (i.e., MMSE). With PST’s considerable experience in computerized testing and working with older populations, and in accordance with PST’s company mission to advance the fields of research and assessment, CAMCI would provide an option for PCPs and clinicians to provide therapeutic intervention prior to a diagnosis of dementia. Recent additions to CPT codes permit insurance reimbursement for neuropsychological testing by a computer, including time for the physician's or clinical psychologist's interpretation and reporting. The introduction of this new revenue stream for PCPs and clinicians, coupled with the characteristics of being brief and self-administered make CAMCI an attractive option for improving early intervention, providing an intelligent business solution for healthcare professionals, and a useful and effective tool that allows physicians to better evaluate and serve their patients. The specific aims included in the current project are focused on activities required to successfully move CAMCI to commercialization by extending support for late stage research and product development, including regulatory strategy and intellectual property development, data collection to replicate key studies, product extension through increasing minority representation, and development of a measure of meaningful change. The ultimate goal is to streamline the commercialization of CAMCI, and to provide a useful and effective tool in the detection of cognitive dysfunction to physicians, the providers of the majority of healthcare to the elderly population, to improve efficiency and effectiveness of clinical practice.

Public Health Relevance Statement:
Project Narrative Cognitive impairment is a significant health problem in the United States, resulting in costs over $100 billion a year. We will provide an efficient, effective, and financially intelligent solution to Primary Care Physician’s to identify cognitive impairment in the earliest stages, delay progression through appropriate treatment, and to afford patients the opportunity to make future plans at a time when symptoms are mild and patients are able to make informed decisions concerning financial and life activities. This has the potential to delay devastating effects of cognitive impairment, and to lessen the financial burden on the health care system in the United States.

Project Terms:
African American; Agreement; Algorithms; Alzheimer's Disease; Assessment tool; Businesses; Caring; Characteristics; Classification; Clinical; Clinical effectiveness; clinical practice; Clinical Research; Clinical Trials; clinically significant; Cognitive; cognitive function; Collection; college; commercialization; Communities; computerized; computerized tools; Computers; Consult; cost; Coupled; Current Procedural Terminology Codes; Data Collection; Data Set; Dementia; design; Detection; Development; Development Plans; Devices; Diagnosis; Disease; Disease Progression; Early Diagnosis; Early Intervention; Effectiveness; Elderly; ethnic minority population; Evaluation; experience; Failure; Family; Feedback; Funding; Future; Goals; Grouping; Health; Health Personnel; Health Professional; Healthcare; Healthcare Systems; Hispanics; Hospitals; Impaired cognition; Impairment; improved; Individual; Insurance; Intellectual Property; Investments; Lawyers; Legal patent; Life; Market Research; Marketing; Measures; Medical; Medical Device; meetings; Memory impairment; Minority; Mission; neurophysiology; Neuropsychological Tests; Neuropsychology; older patient; Older Population; Outcome; Patients; Physicians; Physicians' Offices; Population; portability; Primary Care Physician; product development; Provider; Psychologist; Psychology; Quality of life; racial and ethnic; Readability; Recruitment Activity; Reporting; Research; research and development; Research Personnel; Retirement; Sampling; Schedule; screening; Secure; Self-Administered; Sensitivity and Specificity; Site; slow potential; Software Tools; Stream; Symptoms; Testing; Therapeutic Intervention; Time; tool; Training; United States; Universities; usability; Validation