Latest news with #AAIC
Yahoo
16-05-2025
- Health
- Yahoo
Alzheimer's Association Statement on First Blood Test Used in Diagnosing Alzheimer's Disease Cleared for Use by FDA
CHICAGO, May 16, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has cleared the first blood test to aid in diagnosis of Alzheimer's disease. The test detects amyloid plaques, a hallmark of Alzheimer's disease, through a blood draw, making it less invasive than other more commonly used diagnostic tools. "Today marks another important step in Alzheimer's disease diagnosis," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer and medical affairs lead. "For too long Americans have struggled to get a simple and accurate diagnosis; with today's action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier." While there is no single, stand-alone test to diagnose Alzheimer's disease today — including this newly approved test — blood testing can be an important piece of the diagnostic process. Currently, physicians primarily use other, more well-established diagnostic tools combined with medical history, neurological exams, cognitive and functional assessments, brain imaging, spinal fluid analysis — and, increasingly, blood tests — to make an accurate diagnosis and to understand which patients are eligible for approved treatments. According to the FDA, "the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer's disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease." There are a variety of laboratory-developed tests on the market that can be used to detect blood-based biomarkers associated with Alzheimer's. This is the first that has been cleared by the FDA for use. For many years, blood tests have been used in clinical trials. Increasingly, they are being used by specialists in clinical settings, often as a first pass detection tool followed by additional testing. "Blood-based biomarkers are reshaping how we identify and understand Alzheimer's disease," continued Carrillo. "At the same time, there are important questions for health care professionals to consider; in particular, who should be tested and when." The Alzheimer's Association is leading the development of clinical practice guidelines for the use of blood biomarker tests in specialty care settings, which will be debuted this summer at the Alzheimer's Association International Conference (AAIC), July 27-31 in Toronto and online. The first iteration of the clinical practice guidelines will provide evidence-based recommendations for specialists to help guide them through the decision-making process around who should be tested and when. In the meantime, the Association urges providers to refer to the 2022 appropriate use recommendations for blood tests in clinical practice and trial settings. The 2025 Alzheimer's Disease Facts and Figures special report found that nearly 4 in 5 Americans would want to know if they had Alzheimer's disease before it impacted their lives. Specifically, 91% of Americans say they would want to take a simple test — such as a blood biomarker test — if it were available. Access to early treatment and care is the main reason cited for wanting a simple test. "This interest in early diagnosis and treatment highlights how important it is that we keep advancing toward diagnostic testing that is simple to administer and widely available," Carrillo said. This is the latest step toward better diagnosis and eventual treatment of Alzheimer's disease made possible by historic investment in Alzheimer's and dementia research by the National Institutes of Health (NIH), the Alzheimer's Association and other private entities. As a result of this increased investment, scientists have been able to work at a more rapid pace to advance basic disease knowledge, identify ways to reduce risk, uncover new biomarkers for early diagnosis and drug targeting, and develop disease-modifying treatments. About the Alzheimer's AssociationThe Alzheimer's Association is a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit or call 800.272.3900. View original content to download multimedia: SOURCE Alzheimer's Association
National Post
28-04-2025
- Health
- National Post
Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Clinical Data at 2025 Alzheimer's Association International Conference
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (NASDAQ: ACOG) (the 'Company' or 'Alpha Cognition') today announced three upcoming presentations at the 2025 Alzheimer's Association International Conference (the 'AAIC'), taking place July 27–31, 2025 in Toronto, Canada. Article content Article content The presentations will highlight clinical studies supporting ZUNVEYL (benzgalantamine), the Company's lead product and a novel galantamine prodrug approved by the FDA in July 2024 and commercially launched in March 2025. The studies demonstrated bioequivalence to galantamine IR and ER and were integral to the NDA submission and approval. Article content 'We're excited to share data that underscore ZUNVEYL's potential to deliver meaningful clinical benefit to patients,' said Dr. Denis Kay, Chief Scientific Officer at Alpha Cognition. 'We believe ZUNVEYL offers an attractive new option for Alzheimer's disease patients and caregivers.' Article content Presentation Schedule at AAIC 2025: Article content Bioequivalence to Galantamine ER under Steady State Conditions Poster #107147 | July 27, 2025 Bioequivalence to Galantamine IR under Fed and Fasting Conditions Poster #107030 | July 28, 2025 Dose Proportionality Across 5–15 mg Range under Fasting Conditions Poster #107255 | July 30, 2025 Article content About ZUNVEYL Article content ZUNVEYL is a twice-daily treatment designed to address the cognitive symptoms of mild-to-moderate Alzheimer's disease. By enhancing cholinergic function in the brain, ZUNVEYL supports memory, learning, and overall cognitive function, offering a meaningful improvement for patients and their caregivers. Article content Targeted for the long-term care market, ZUNVEYL is uniquely positioned to address the needs of a growing patient population in a segment valued at $2 billion annually in the United States. Alpha Cognition is committed to ensuring ZUNVEYL is accessible to patients and caregivers, supported by robust market access strategies and a dedicated commercial team. 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 Contraindications Article content ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL. Article content Warnings and Precautions Article content Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of (ZUNVEYL) tablets. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Cardiovascular conditions: Cholinesterase inhibitors, including ZUNVEYL, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil. Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Genitourinary conditions: Although not observed in clinical trials of ZUNVEYL, bladder outflow obstruction may occur. Pulmonary conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. Monitor for respiratory adverse effects. Article content Article content Adverse Reactions Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content Drug Interactions Article content Cholinesterase inhibitors, including galantamine, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. 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 presentation of ZUNVEYL at the 2025 Alzheimer's Association International Conference, the contraindications of ZUNVEYL, the warning and precautions of ZUNVEYL, the adverse reactions of ZUNVEYL, the clinical benefits of ZUNVEYL to patients, ZUNVEYL's efficacy and tolerability, ZUNVEYL's long-term benefits, the Company's timing and planned activities to launch ZUNVEYL, potential timing for the availability of ZUNVEYL, potential future developments of ZUNVEYL, the potential market size for ZUNVEYL, the Company's business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company's products. 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 January 10, 2025 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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Ottawa Citizen
28-04-2025
- Health
- Ottawa Citizen
Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Clinical Data at 2025 Alzheimer's Association International Conference
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (NASDAQ: ACOG) (the 'Company' or 'Alpha Cognition') today announced three upcoming presentations at the 2025 Alzheimer's Association International Conference (the 'AAIC'), taking place July 27–31, 2025 in Toronto, Canada. Article content Article content The presentations will highlight clinical studies supporting ZUNVEYL (benzgalantamine), the Company's lead product and a novel galantamine prodrug approved by the FDA in July 2024 and commercially launched in March 2025. The studies demonstrated bioequivalence to galantamine IR and ER and were integral to the NDA submission and approval. Article content Article content 'We're excited to share data that underscore ZUNVEYL's potential to deliver meaningful clinical benefit to patients,' said Dr. Denis Kay, Chief Scientific Officer at Alpha Cognition. 'We believe ZUNVEYL offers an attractive new option for Alzheimer's disease patients and caregivers.' Article content Presentation Schedule at AAIC 2025: Article content Bioequivalence to Galantamine ER under Steady State Conditions Poster #107147 | July 27, 2025 Bioequivalence to Galantamine IR under Fed and Fasting Conditions Poster #107030 | July 28, 2025 Dose Proportionality Across 5–15 mg Range under Fasting Conditions Poster #107255 | July 30, 2025 Article content About ZUNVEYL Article content ZUNVEYL is a twice-daily treatment designed to address the cognitive symptoms of mild-to-moderate Alzheimer's disease. By enhancing cholinergic function in the brain, ZUNVEYL supports memory, learning, and overall cognitive function, offering a meaningful improvement for patients and their caregivers. Article content Targeted for the long-term care market, ZUNVEYL is uniquely positioned to address the needs of a growing patient population in a segment valued at $2 billion annually in the United States. Alpha Cognition is committed to ensuring ZUNVEYL is accessible to patients and caregivers, supported by robust market access strategies and a dedicated commercial team. 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 Warnings and Precautions Article content Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of (ZUNVEYL) tablets. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Cardiovascular conditions: Cholinesterase inhibitors, including ZUNVEYL, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil. Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Genitourinary conditions: Although not observed in clinical trials of ZUNVEYL, bladder outflow obstruction may occur. Pulmonary conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. Monitor for respiratory adverse effects. Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content Drug Interactions Article content Cholinesterase inhibitors, including galantamine, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. 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 presentation of ZUNVEYL at the 2025 Alzheimer's Association International Conference, the contraindications of ZUNVEYL, the warning and precautions of ZUNVEYL, the adverse reactions of ZUNVEYL, the clinical benefits of ZUNVEYL to patients, ZUNVEYL's efficacy and tolerability, ZUNVEYL's long-term benefits, the Company's timing and planned activities to launch ZUNVEYL, potential timing for the availability of ZUNVEYL, potential future developments of ZUNVEYL, the potential market size for ZUNVEYL, the Company's business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company's products. 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 January 10, 2025 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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