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Cognivue studying post-COVID cognitive function

Rochester neuroscience company Cognivue Inc. has begun a nationwide clinical study to assess post-COVID-19 Syndrome.

COG-COVID19 is an open-label, prospective, two-armed comparison clinical study to assess the impact of COVID-19 on cognitive function. Researchers from the University of Southern California, Case Western Reserve University and the University of California Irvine are collaborating on the 24-month, 1,000-person study. Enrollment is underway for the investigation, which will compare the impact of the coronavirus on the cognitive function of 500 participants who have been diagnosed, treated and recovered from COVID-19 versus 500 uninfected participants.

The primary objective is to evaluate the percentage of cognitive decline observed in both study arms using assessments of Cognivue Clarity, the Mini-Mental State Exam (MMSE) and the Montreal Cognitive Assessment (MoCA), officials explained.

“Cognitive impairment is a frequent and persistent issue among patients either recovered or recovering from critical illness such as COVID-19,” said Fred Ma, principal investigator and medical monitor of the study, and chief medical officer and senior vice president at Cognivue. “The direct impact of the pandemic on cognitive function and the indirect effects that result from the increased frequency and severity of psychiatric disorders, including post-COVID-19 syndrome (long haul syndrome), emphasize the need for prospective monitoring and management of cognitive dysfunction. Cognitive function testing should be part of the recovery plan for individuals who experience the direct or indirect whiplash of COVID-19.”

Cognivue Clarity is an FDA-cleared computerized testing tool designed to assess early signs of cognitive impairment. The technology objectively, quantitatively and reliably identifies changes in cognitive function that could indicate an impairment that patients may treat or manage.

The study will have a secondary endpoint to see the correlation of depression and anxiety scales and/or Geriatric Depression Scale (GDS) with Cognivue scores while comparing the trend of the difference between both study arms.

Earlier this year, Ma conducted a study titled “COVID-19-Related Stressors and the Role of Cognitive Assessment.” Of the 693 respondents surveyed, 63.5 percent reported anxious symptoms, of which 26.6 percent were new-onset; and 51.7 percent reported depressive symptoms, of which 21.1 percent were new-onset. Overall, 20.8 percent described a worsening of their cognitive health since the pandemic began, with a greater likelihood of such among those who also experience worsening of a health-related issue.

“The prevalence of stressors known to affect cognitive function has increased during the pandemic, underscoring the necessity of proactively establishing routine neurocognitive assessment in clinical practice in order to better mitigate the impending mental health crisis,” Ma said.

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Cognivue to join other heavy hitters in Alzheimer’s study

Rochester’s Cognivue Inc. has been selected by the Global Alzheimer’s Platform (GAP) to participate in its pioneering Bio-Hermes clinical trial study. Also participating in the study are Eli Lilly & Co., AbbVie, Merck, the Alzheimer’s Drug Discovery Foundation and other respected biopharma, technology and nonprofit entities.

Bio Hermes is the first platform study to investigate and compare blood-based biomarkers, digital markers and legacy assessments in 1,000 people over the age of 60 screened for preclinical Alzheimer’s Disease (AD), prodromal AD, or mild dementia AD. The use of biomarkers could lead to earlier and more frequent detection of amyloid build-up, prompting those affected to seek early intervention, including participation in clinical trials for Alzheimer’s prevention or treatment.

“We are excited about the collaboration with the Global Alzheimer’s Project and the opportunity to be part of the groundbreaking Bio-Hermes clinical study. This is the first wide-scale application of Cognivue technology along with state-of-the-art frontline diagnostic tools such as blood-based biomarkers and brain image scanning. This could be a milestone development to create a gold standard for the future of Alzheimer’s Disease assessment and diagnostics,” said Cognivue President and CEO Tom O’Neill. “Our ability to objectively, quantitatively, and reliably identify cognitive status further assist with the accurate diagnosis for potential cognitive impairment, which can then be treated or managed.”

Cognviue’s technologies are designed to give health care providers a useful tool for cognitive evaluation and diagnosis. The digital system is engineered to eliminate bias and variability throughout the test that establishes cognitive baselines and provides a concurrent monitoring vehicle for the evaluation and treatment of cognitive issues over time.

“The Bio-Hermes clinical trial will evaluate the most promising digital and blood biomarker tests, and we’re pleased to have Cognivue as one of our digital assessments for cognitive function,” said John Dwyer, president of the Global Alzheimer’s Platform Foundation. “This self-administered test could allow medical practices in any community to detect cognitive decline and prompt steps to diagnose Alzheimer’s. In turn, that means patients will be able to make timely decisions about treatment or participation in research.”

Cognivue is a neuroscience company focused on cognitive health with the world’s first FDA-cleared computerized test of cognitive function. The Cognivue device and technology are based on years of research that uses adaptive psychophysics to focus on cortical information processing by testing key cognitive domains.

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Cognivue names new chief medical officer

Cognivue Inc. has tapped a health sciences industry veteran as its chief medical officer and senior vice president.

Fred Ma M.D.
Fred Ma M.D.

Fred Ma M.D. brings nearly four decades of experience to the role. His career spans global medical device and pharmaceutical development and commercialization, as well as advancing neurological disorder treatments, therapies and prevention as a neurosurgeon.

“Dr. Ma’s leadership has earned the highest respect among his clinical, industry and research peers worldwide. He has the rare ability to translate extensive medical and scientific knowledge into accessible insights and market-leading products,” said Tom O’Neill, president and CEO of Cognivue. “We believe he will help take us to the next level with even better products and deeper relationships to come. His contributions in supporting existing customers and extending clinical validation through studies, manuscripts and more will be invaluable.”

Cognivue’s technologies identify changes in cognitive function that could indicate an impairment, which can then be treated or managed. Its proprietary algorithms are integrated into a portfolio of products that generate rapid self-administered, FDA-cleared computerized assessments designed for simple implementation into busy practices.

Ma most recently served as president and chief operating officer of Innovative Health Sciences, the immunology drug and subcutaneous drug infusion device company. He has served as chief medical officer for KORU Medical Systems, Innovacyn, and GE Healthcare, as well as held leadership roles within Johnson & Johnson, Merck and elsewhere. Ma managed more than 100 new product developments with more than 600 successful clinical trials and regulatory filings in the Americas, Europe, Africa and Asia-Pacific.

Ma also was a practicing neurosurgeon at the China-Japan Friendship Hospital in Beijing and the University of Tokyo Hospital, including tenures as attending physician and resident general chief.

“The passion shown by Dr. Ma for cognitive assessment and evaluation was evident from our first conversation. Among his many accomplishments, he has been involved in drug research and clinical investigation for cognitive modulation on ADHD, Alzheimer’s and dementia, plus near-infrared light therapy device development for TBI and PTSD. It’s hard to overstate his potential contributions as he becomes part of our fast-growing organization,” O’Neill said.

Cognivue this year introduced its two newest products, Cognivue Clarity and Cognivue Thrive, which provide early testing for proactive intervention via portable, battery-powered formats for use in practice and non-clinical settings. Its platforms are used across the health care spectrum, including in audiology, optometry, neurology, retail pharmacy, employee wellness, law enforcement and general practice.

[email protected] / 585-653-4021
Follow Velvet Spicer on Twitter: @Velvet_Spicer