Latest news with #mTBI
National Post
01-07-2025
- Health
- National Post
Alpha Cognition Announces Positive Pre-Clinical Data for ALPHA-1062 Use in a Military Relevant Model of Repetitive Mild Traumatic Brain Injury
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' [ACI], or the 'Company'), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury (mTBI). The data provides additional evidence of benefits of ALPHA-1062, in the treatment of mTBI resulting from repetitive blast trauma, a highly relevant military injury. Service related mTBI results in a high incidence of persistent physical and emotional challenges for patients, impacting their quality of life and that of their families. Additionally, a history of mTBI increases the risk of dementia diagnosis later in life. Article content Data analysis for this study, supported by the US Department of Defense and conducted in collaboration with US Department of Veterans Affairs investigators and the Seattle Institute of Biomedical and Clinical Research, has been concluded, demonstrating that ALPHA-1062 administration following blast induced mTBI, results in a notable reduction in indices of TBI associated neuropathology. Article content ALPHA-1062 administration reduced the brain levels of three toxic forms of a brain protein Tau. One of these forms (pTau 217) has been suggested to identify TBI patients at greater risk of long-term cognitive decline. It is also one of the earliest emerging biomarkers in Alzheimer's disease. A second form of toxic Tau (pTau-S202/T205) can be found in very early-stage pathology in the brains of Alzheimer's patients before the appearance plaques and tangles. The third form (pTau 231) is elevated in early Alzheimer's disease and TBI. Taken together, reduction of these toxic forms of pTau suggests a potential role for ALPHA-1062 in the treatment of TBI and that this may additionally positively impact the risk of later developing Alzheimer's disease. Article content Additional benefits of ALPHA-1062 were observed following blast trauma. High dose ALPHA-1062 reduced the numbers of myeloid cells which play a critical role in neuroinflammation and tissue repair, as well as the number of astrocytes, which regulate neurotransmitters like glutamate and GABA to support neuronal health. These changes are consistent with reduced neuroinflammation following ALPHA-1062 administration. Finally, nerve growth factor receptor expression, which plays an important role in neuronal survival, was increased in an ALPHA-1062 dose-dependent manner. 'These outcomes are in agreement with those of an earlier pre-clinical study in a moderate TBI animal model, both studies demonstrated protective effects of ALPHA-1062, providing support for the continued development of ALPHA-1062 for the treatment of traumatic brain injury,' said Denis Kay, ACI's Chief Scientific Officer. Article content Alpha Cognition's next steps in this program will be to complete formulation of ALPHA-1062 for sublingual administration and conduct a bridging pharmacokinetic study vs. ZUNVEYL® (Benzgalantamine) and an existing intranasal formulation of ALPHA-1062. Article content About Alpha Cognition Inc. Article content Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. Article content ALPHA-1062 formulated as a delayed release oral tablet ZUNVEYL (Benzgalantamine) is FDA approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI. Article content Forward-looking Statements Article content This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law. 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Yahoo
17-06-2025
- Health
- Yahoo
Health Canada approves Abbott's i-STAT TBI test for suspected concussions
Health Canada has granted approval for Abbott's i-STAT TBI test cartridge, enabling clinicians to evaluate suspected concussions more effectively. The authorisation allows for the use of the test cartridge with whole blood, enabling clinicians to get lab-quality results in 15 minutes. Previously, mild traumatic brain injury (mTBI) assessment tests were authorised only for plasma or serum samples, necessitating lab processing. The approval facilitates testing in diverse healthcare settings, potentially expanding to pharmacies, clinics without radiology, and even sporting event sidelines. The i-STAT TBI test is designed to assess those who are 18 years and above with suspected mTBI (commonly referred to as concussion). It can help rule out the requirement for a head computed tomography (CT) scan and guide the further steps for individual care, using other clinical information. The authorisation also extends the test's utility to assess individuals up to 24 hours post-injury, addressing situations where individuals may delay seeking medical attention. Abbott's market offerings for TBI testing already include the i-STAT TBI Plasma test and the ARCHITECT and Alinity i lab tests for serum and plasma. To be used with the i-STAT Alinity System, the i-STAT TBI test cartridge needs only a small blood sample. It measures two brain-specific biomarkers, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), released into the bloodstream after brain injury. If levels of these biomarkers are below a certain threshold, a serious injury is unlikely, and a CT scan may be avoided. Abbott diagnostics business senior medical director Beth McQuiston said: "We're proud of this important step forward in advancing the standard of care for concussions. 'With this approval, right from the patient's bedside, clinicians are now able to order a rapid blood test that can provide powerful objective information, quickly. This dramatically changes the efficiency in the emergency room and helps optimise patient care." In April 2025, the company reported new data from its Volt CE Mark Study, indicating that individuals treated with pulsed field ablation (PFA) therapy using the Volt PFA System for atrial fibrillation (AFib) showed efficacy and safety up to 12 months. "Health Canada approves Abbott's i-STAT TBI test for suspected concussions" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
16-06-2025
- Health
- Yahoo
Abbott Receives Health Canada Authorization for Whole Blood Rapid Test to Help Assess Suspected Concussions
The test, run on Abbott's portable i-STAT® Alinity® instrument, uses whole blood to help evaluate patients with a suspected mild traumatic brain injury (mTBI), otherwise known as concussion The test produces lab-quality results in 15 minutes Clinicians can get a result at the patient's bedside, making the test accessible at urgent care clinics and healthcare settings outside of the hospital emergency room The test can be used to help evaluate patients up to 24 hours after injury MISSISSAUGA, ON, June 16, 2025 /CNW/ -- Abbott (NYSE: ABT) announced today that Health Canada has approved the company's i-STAT TBI test cartridge for use with whole blood, helping clinicians to assess suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests used to help assess mild traumatic brain injury (mTBI) were only authorized for use with plasma or serum, requiring samples to be sent to a lab for processing. This new authorization will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments, including urgent care clinics. This is an important step toward a future where testing could be done in settings such as in pharmacies, clinics without radiology or even in locations such as the sidelines of a sporting event. "Particularly in the emergency setting, we have long needed a reliable and expedient way to assess and triage patients for urgent computed tomography (CT) imaging of the brain after head trauma," said Andrew Beckett, M.D., a trauma surgeon and medical director of the Trauma Program at St. Michael's Hospital, Unity Health Toronto, and an associate professor at the University of Toronto. "The availability of a rapid point of care and objective test for traumatic brain injury will be a major advancement in emergency care as it can help facilitate immediate and precise diagnosis, ensuring prompt, appropriate treatment." The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mTBI, commonly known as a concussion. Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care in conjunction with other clinical information. The ability to perform the test with a whole blood sample means testing can take place in healthcare settings without a lab, which helps to accelerate head trauma evaluation. With this authorization, the i-STAT TBI test cartridge can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait to seek care. It is estimated that 165,000 Canadians will experience a TBI this year.1 Likewise, each year in Canada, more than 20,000 people are hospitalized for TBI, which can range from mild to severe and include concussions.2 Among all types of TBIs, concussions are the most common, accounting for approximately 80 to 95 percent of such injuries.3 Even a mild form of TBI can have long-term consequences.2 For decades, standard TBI assessment has remained the same, with doctors leveraging tools such as the Canadian CT Head Rule which uses the Glasgow Coma Scale, a subjective assessment as well as CT scans, to detect brain tissue damage or lesions. A blood test provides objective information and helps remove the ambiguity of a standard concussion assessment. "Abbott has pioneered breakthroughs in TBI testing technology for more than a decade," said Beth McQuiston, M.D., senior medical director in Abbott's diagnostics business. "We're proud of this important step forward in advancing the standard of care for concussions. With this approval, right from the patient's bedside, clinicians are now able to order a rapid blood test that can provide powerful objective information, quickly. This dramatically changes the efficiency in the emergency room and helps optimize patient care." This approval expands Abbott's TBI test on market offerings, which already includes the i-STAT TBI Plasma test and the ARCHITECT® and Alinity i lab test (serum and plasma). How the test works: The i-STAT TBI test cartridge with the i-STAT Alinity System requires a small venous blood sample – just a few drops applied to the test cartridge. The cartridge is then inserted into the portable i-STAT Alinity instrument. The test measures two brain-specific biomarkers that are released into the blood stream when there is a significant brain injury. If neither of these biomarkers measured are above an established cutoff, a significant injury has likely not occurred, and a CT scan can likely be avoided. Testing for these two biomarkers – ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) – following an injury can provide essential and objective information about a patient's condition and can help healthcare providers decide an appropriate treatment plan. About Abbott:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and YouTube. The i-STAT TBI test cartridge was developed with support by the U.S. Department of Defense U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA). The USAMRDC has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than two decades and has played a critical role in developing the TBI test on Abbott's i-STAT Alinity platform. (Reference to USAMRDC and USAMMDA does not imply or constitute endorsement by these organizations or by the Department of Defense or the U.S. Army.) The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team was the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care. References 1 Brain Injury Canada. Statistics: Traumatic brain injury (TBI) general statistics. Available at Accessed on April 29, 2025.2 Government of Canada. Injury in review, 2020 edition: Spotlight on traumatic brain injuries across the life course. Available at Accessed November 2024.3 Statistics Canada. Self-reported concussions in Canada: A cross-sectional study. Available at Accessed November 2024. SOURCE Abbott View original content to download multimedia: Sign in to access your portfolio
