Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03512301 |
| Other study ID # |
13 |
| Secondary ID |
2SB1AG037357-04A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 8, 2019 |
| Est. completion date |
May 31, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Psychology Software Tools, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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, and there is a lack of
physician's time to use the tools, leading to a failure to provide therapeutic intervention
at the earliest stages of loss to potentially slow the progression of disease. Psychology
Software Tools, Inc. (PST) has developed the Computer Assessment of Memory and Cognitive
Impairment (CAMCI), a computerized screening tool for 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 tools most frequently used within the primary care physician
(PCP) office. CAMCI would provide an option for PCPs and clinicians to provide therapeutic
intervention prior to a diagnosis of dementia. Recent additions to Current Procedural
Terminology (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 focus 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 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.
