New Digital Cognitive Assessment Tool Receives Positive FDA Review

New Digital Cognitive Assessment Tool Receives Positive FDA Review

The cognitive science company Cogstate received approval to market a new digital cognitive assessment tool to assist healthcare professionals in measuring cognition in patients ages 6 to 99, either in-clinic or at home. This tool, called the Cognigram, could help measure the progression of Parkinson’s disease and other illnesses.

The Cognigram can now be marketed in the United States after the U.S. Food and Drug Administration (FDA) reviewed the company’s 510(k) submission and found it to meet the necessary requirements established by the FDA’s Center for Devices and Radiological Health.

An individual’s cognition may be affected by mild cognitive impairment (MCI), Alzheimer’s disease, Parkinson’s disease, concussion, head injury, HIV-related dementia, major depressive disorder, and secondary effects of medication or surgery, among others, including psychological states like stress or fatigue.

The Cognigram system is a simple computerized battery of tests based on a card game designed to detect and monitor change in cognitive function over time. The system can be used to assess cognition on a single occasion or cognitive change over periodic assessments, regardless of language, education, and cultural background.

The Cognigram will be made available to U.S. health systems, hospitals, physician practices, elderly care organizations, schools, and sports teams.

“After more than fifteen years of intense efforts in supporting academic research and pharmaceutical clinical trials around the world, Cogstate is excited to enter the U.S. market for cognitive assessment on the front lines of clinical practice,” Frank Cheng, president of Cogstate Healthcare, said in a press release. “We look forward to bringing the proven and widely-published Cognigram technology into the healthcare ecosystem to benefit an exponentially larger pool of patients.”

2015 study explored controversies about mild cognitive impairment in Parkinson’s disease (PD-MCI), noting that cognitive impairment in Parkinson’s is increasing.

MCI is a known risk factor for dementia in Parkinson’s, but this process isn’t fully understood. In this study, the authors explored signs of PD-MCI, biomarkers, and how PD-MCI factors into clinical trial design.

The article also explores how PD-MCI definitions have evolved over the years, and how prevention may be incorporated into PD treatment. Today, monitoring PD-MCI is commonly incorporated as a measurement for PD clinical trials.

Titled, “Mild cognitive impairment: an update in Parkinson’s disease and lessons learned from Alzheimer’s disease,” the article was published in Neurodegenerative Disease Management.


  1. Jeff Bray says:

    I have used this test on numerous occasions and am not a fan of the structure. The test fine for a “one-time” test when used as a baseline but when you re-test a person, you cannot immediately review and compare the results from a post-injury test to the baseline. When testing multiple individuals, you must log out and log in EACH TIME.
    They’ve built in “practice tests” for each section with no way to bypass the practice tests. When re-testing a person, the practice tests cause the person being tested to become frustrated because they don’t need the practice test every time – the clinician becomes very frustrated as well. There are other issues as well… the end of the day, this test was designed without the “end user” in mind. They have priced themselves and designed themselves out of being useful in the sports setting.

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