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Alpha Cognition Announces First Patient Enrolled in BEACON Real-World Effectiveness Study

MWN-AI** Summary

Alpha Cognition Inc. (NASDAQ: ACOG) has announced a significant milestone with the enrollment of the first patient in the BEACON study, a Phase 4 real-world effectiveness trial aimed at evaluating the impacts of ZUNVEYL® on patients with Alzheimer’s disease in long-term care settings. This study aims to gather practical data on cognition, neuropsychiatric symptoms, and the safety and tolerability of ZUNVEYL, thus complementing previous clinical trial findings and addressing the critical therapeutic needs within nursing homes.

Kurt Grady, Alpha Cognition’s Vice President of Medical Affairs, expressed optimism regarding the study, highlighting the urgent requirement for effective therapies for patients in these environments. By producing real-world clinical evidence, BEACON seeks to bolster the clinical foundation for ZUNVEYL, offering valuable insights for healthcare professionals and caregivers.

The BEACON study plans to enroll approximately 200 patients across various clinical sites, with ongoing monitoring of efficacy and adverse events throughout its duration. Alpha Cognition anticipates reporting topline results by the fourth quarter of 2026 after the completion of patient enrollment and follow-up testing.

ZUNVEYL is a newly approved drug that acts as an acetylcholinesterase inhibitor, designed to treat Alzheimer’s disease while minimizing gastrointestinal side effects. Its mechanism of action differentiates it from other treatments by binding to specific neuronal nicotinic receptors that can enhance cognitive function. In addition to ZUNVEYL, Alpha Cognition is also developing ALPHA-1062 for more severe cognitive impairment and as an intranasal formulation for mild traumatic brain injury.

These developments signal a promise for improved treatment options in neurodegenerative diseases, despite the inherent uncertainties in clinical research and market acceptance that the company continues to navigate.

MWN-AI** Analysis

Alpha Cognition Inc. (NASDAQ: ACOG) recently announced the enrollment of the first patient in its BEACON real-world effectiveness study for ZUNVEYL®, a treatment for Alzheimer’s disease. This Phase 4 study aims to assess the impact of ZUNVEYL in long-term care settings, focusing on cognition, neuropsychiatric symptoms, and safety. Enrollment of approximately 200 patients across multiple sites will provide essential real-world data that could enhance the clinical foundation supporting ZUNVEYL’s commercial launch.

Investors should note that the successful completion of the BEACON study—set to report topline results in Q4 2026—could significantly impact Alpha Cognition's stock performance. Given the high unmet need in Alzheimer’s treatments, positive outcomes may bolster the company's market position and drive interest from healthcare providers. With the rising prevalence of neurodegenerative diseases, the demand for effective therapies represents a substantial growth opportunity for Alpha Cognition.

However, investing in Alpha Cognition carries notable risks. The company faces uncertainties about the efficacy and tolerability of ZUNVEYL, along with challenges related to regulatory approvals and market adoption. The volatile nature of clinical-stage biopharma stocks can lead to significant price swings, particularly surrounding clinical trial outcomes. Therefore, potential investors should closely monitor patient enrollment rates, interim results from the BEACON study, and any updates regarding the commercialization strategy for ZUNVEYL.

In conclusion, while the BEACON study activation is a positive development for Alpha Cognition, prospective investors should maintain a cautious approach, understanding both the potential rewards and inherent risks associated with biopharmaceutical investments. Diversifying portfolios and considering long-term strategies will be prudent as Alpha Cognition navigates this crucial stage in its development timeline.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: Business Wire

Alpha Cognition Inc. (NASDAQ: ACOG) (“Alpha Cognition,” “ACI,” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for neurodegenerative diseases, today announced the enrollment of the first patient in BEACON , a Phase 4 real world effectiveness study, to assess the impact of ZUNVEYL® in the Long-Term Care (LTC) setting.

The BEACON study is designed to assess the real-world impact of ZUNVEYL on cognition, neuropsychiatric symptoms, safety, and tolerability in patients with Alzheimer’s disease residing in nursing homes. By generating data in routine clinical practice, the study aims to complement findings from earlier clinical trials and provide practice-relevant evidence in a care setting with significant unmet need that will further support the Company’s commercialization efforts.

“Enrollment of first patient in the BEACON study represents a significant milestone for Alpha Cognition,” said Kurt Grady, Alpha Cognition’s Vice President of Medical Affairs. “This study is designed to generate real-world clinical evidence in the nursing home environment, where the need for effective and well-tolerated therapies is particularly high. If positive, these data have the potential to further strengthen the clinical foundation for ZUNVEYL and support our ongoing commercial launch by providing meaningful insights for healthcare providers, patients, and caregivers.”

BEACON is a post-approval study expected to enroll approximately 200 patients across multiple clinical sites. The study will collect efficacy data and monitor adverse events throughout the study period, contributing to ongoing post-market evaluation and informing real-world clinical use of ZUNVEYL in the long-term care population. Alpha Cognition expects to report topline results in the fourth quarter of 2026, following completion of enrollment and patient follow-up.

About Alpha Cognition Inc.

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.

ZUNVEYL is a patented drug 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 an intranasal formulation for Cognitive Impairment with mTBI.

This news release includes forward-looking statements within the meaning of applicable United States and Canadian 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 with the anticipated results of the BEACON study and the potential for such results to further strengthen the clinical foundation for ZUNVEYL and support its ongoing commercial launch, 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, including bridge funding, 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 www.sedar.com 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 Annual Report on Form 10-K as filed with the SEC on May 31, 2025 and available at www.sec.gov . 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260225883160/en/

For further information:
Investor Relations
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com

FAQ**

How does Alpha Cognition Inc. (ACOG) plan to leverage the results from the BEACON study to enhance the commercialization of ZUNVEYL in the competitive Alzheimer's treatment market?

Alpha Cognition Inc. plans to leverage the favorable results from the BEACON study to strengthen ZUNVEYL's positioning in the Alzheimer's treatment market by showcasing its efficacy and safety profile to attract investors and secure strategic partnerships for commercialization.

What specific criteria will Alpha Cognition Inc. (ACOG) use to assess the efficacy and safety of ZUNVEYL in the long-term care setting during the BEACON study?

Alpha Cognition Inc. (ACOG) will evaluate the efficacy and safety of ZUNVEYL in the long-term care setting during the BEACON study based on specific criteria including cognitive function improvement, behavior changes, overall health status, and safety profile indicators.

How might the outcomes of the BEACON study impact investor confidence in Alpha Cognition Inc. (ACOG) and its future clinical development plans?

The outcomes of the BEACON study could significantly boost investor confidence in Alpha Cognition Inc. (ACOG) by validating its clinical approach and potential market viability, thereby attracting funding for future development plans and enhancing the company's growth prospects.

Given the potential risks outlined, what contingency plans does Alpha Cognition Inc. (ACOG) have in place should ZUNVEYL not achieve favorable results in the BEACON study?

Alpha Cognition Inc. has contingency plans that include diversifying their pipeline, seeking alternative funding sources, and potentially exploring partnerships to mitigate risks associated with unfavorable results from the BEACON study on ZUNVEYL.

**MWN-AI FAQ is based on asking OpenAI questions about Alpha Cognition Inc. (NASDAQ: ACOG).

Alpha Cognition Inc.

NASDAQ: ACOG

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