Full Press Release Details
VANCOUVER, British Columbia & GRAPEVINE, Texas--(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 inBEACON, 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 approximately200 patientsacross 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 atwww.sedar.comand 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 atwww.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.