Brain Injury, Chronic

MONDAY, Sept. 23, 2024 -- More than one-third of living former professional American-style football (ASF) players report perceived chronic traumatic encephalopathy (CTE), which is associated with an increased prevalence of self-reported suicidality, according to a study published online Sept. 23 in JAMA Neurology . Rachel Grashow, Ph.D., from Harvard University in Boston, and colleagues sought to determine the proportion, clinical correlates, and suicidality of living former professional ASF players with perceived CTE. The analysis included data from 1,980 former professional ASF players (1960 to 2020) participating in the Football Players Health Study at Harvard University (2017 to 2020). The researchers found that 34.4 percent of participants reported perceived CTE. Factors significantly associated with perceived CTE included subjective cognitive difficulties, low testosterone level, headache, concussion signs and symptoms accrued during playing years, depressive/emotional and behavioral dyscontrol symptoms, pain, and younger age. Suicidality was reported by 25.4 percent of participants with perceived CTE and 5.0 percent of those without perceived CTE. Participants with perceived CTE remained twice as likely to report suicidality (odds ratio, 2.06), even when adjusting for established suicidality predictors (e.g., depression). "Perceived CTE represents a novel risk factor for suicidality and, if present, should motivate the diagnostic assessment and treatment of medical and behavioral conditions that may be misattributed to CTE neuropathological change," the authors write. Several authors disclosed ties to the neurodiagnostics industry. Abstract/Full Text Editorial (subscription or payment may be required) Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MONDAY, Sept. 23, 2024 -- One in three former NFL players believe they have football-related brain damage that’s doing untold harm to their lives, a new study finds. Unfortunately, their fears might be harming their mental health on top of whatever risks they face from head injuries sustained during their careers, researchers report. About one-third of nearly 2,000 retired NFL players believe they have chronic traumatic encephalopathy (CTE), a degenerative brain condition linked to repeated head trauma, researchers reported Sept. 23 in the journal JAMA Neurology . Players who suspect they have CTE reported significantly more problems with brain function, low testosterone, depression and chronic pain than those who don’t think they have the condition, researchers found. In addition, about 25% of players who believe they have CTE also reported suicidal thoughts or behaviors, compared with about 5% of those who don’t think they have CTE, results showed. NFL retirees who believe they have CTE are twice as likely to report frequent thoughts of suicide, even after accounting for symptoms of depression, researchers said. These symptoms are potentially related to the dread faced by NFL retirees who are certain they have CTE and expect a long and excruciating decline in their mental function, researchers said. Incurable brain diseases like Alzheimer’s, Parkinson’s and Huntington’s disease also have been associated with elevated suicide rates. “As complex human beings, our beliefs can exert a strong impact on our health,” said researcher Dr. Ross Zafonte , chief of physical medicine and rehabilitation at Massachusetts General Hospital and Brigham and Women’s Hospital in Boston. “The symptoms that raise CTE concerns are real and CTE concerns are valid, but it’s critical to understand that having persistent fears about this condition can take a toll on mental health,” Zafonte added in a hospital news release. Doctors can help NFL retirees with their fears by effectively treating health problems that former players might chalk up to CTE, researchers said. “Many conditions common to former NFL players such as sleep apnea, low testosterone, high blood pressure and chronic pain can cause problems with thinking, memory and concentration,” said lead investigator Rachel Grashow , a research scientist with the Harvard T. H. Chan School of Public Health. “While we wait for advances in CTE research to better address living players’ experiences, it is imperative that we identify conditions that are treatable,” Grashow added. “These efforts may reduce the chances that players will prematurely attribute symptoms to CTE which may lead to hopelessness and thoughts of self-harm.” Players can also help themselves through healthy lifestyle choices, said senior researcher Dr. Aaron Baggish , a professor of medicine at the University of Lausanne in Switzerland. “Interventions including weight loss, exercise, improving sleep and implementing a low-salt diet may improve cognitive function,” Baggish said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

• Falls and car accidents lead incidence of concussions in emergency departments • Spray-dried drug formulation allows for easy delivery to patients • No pharmaceutical treatment is available for concussion; drug, ONP-002, could be first of its kind to treat concussion SARASOTA, Fla., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) (“the Company”), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced the completion of its spray-dried formulation and filling in the nasal device for its lead candidate, ONP-002, for concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity. The prefilled formulation is intended to provide the needed drug-device dosing for the planned Phase IIa clinical trial in concussed patients. For the trial, the Company produced both placebo and ONP-002 drug for use in the Phase IIa clinical trial to be conducted in Australia. The work included the production of ONP-002 as a spray-dried nanoparticle formulation, loading of the powder in Oragenics’ novel breath-propelled intranasal device, and initiating a stability program of both the drug formula alone and within the device. The Phase IIa clinical trial is expected to enroll 40 concussed patients who will receive 1:1 either placebo or the ONP-002 drug, with doses given twice a day for five consecutive days following injury. The trial aims to start treatment within 8 hours of the injury in the emergency department. It is anticipated that patient-reported outcomes and blood biomarkers will be included in the evaluation. “In preparing for the Phase IIa study, we wanted to ensure that ONP-002 could be formulated as a nanoparticle and delivered intranasally as a powder to improve brain exposure. The anti-inflammatory effects of our novel neurosteroid are designed to reduce negative outcomes after a concussion. We believe the combination of the spray-dried powder in our device is ideal for field delivery, increasing the chances of stopping the neuropathology of a concussive injury early,” commented Michael Redmond, President for Oragenics. About Concussion Concussion is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion symptomology is linked to long-term disability and occurs in as high as 20% of concussed patients. About Oragenics Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in fighting infectious diseases and neurological conditions, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com. Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug-device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law. Oragenics, Inc.Janet Huffman, Chief Financial Officer813-286-7900jhuffman@oragenics.com Investor Relations:Rich CockrellCG Capital404-736-3838ogen@cg.capital