Alpha Cognition Reports Positive Top-Line Results from BEACON Real-World Study of ZUNVEYL® in Alzheimer’s Disease

Key Terms

retrospective observational study technical

A retrospective observational study looks back at existing records or data to examine patterns, outcomes or associations, like reviewing past receipts to see what purchases led to returns. It does not assign treatments or control groups, so it can suggest links but cannot prove cause, making its findings useful for early signals or hypothesis generation but less definitive for regulatory approval or investment decisions that require stronger evidence.

acetylcholinesterase inhibitor medical

A drug that slows or blocks the enzyme responsible for breaking down the neurotransmitter acetylcholine, so that the chemical signal stays active longer in the brain or nerves. Investors care because these medicines can improve symptoms in certain neurological and muscular conditions, so their effectiveness, safety profile, regulatory approval, patent protection, and market demand directly affect revenue prospects and risk for companies developing or selling them.

neuropsychiatric symptoms medical

Neuropsychiatric symptoms are changes in mood, thinking, perception or behavior—such as depression, anxiety, memory problems, hallucinations or agitation—that come from underlying brain disorders or their treatments. They matter to investors because they affect how many people need care, how drugs and devices are tested and approved, and the costs and risks faced by health companies; think of them like dashboard warning lights that shape product demand and regulatory attention.

activities of daily living (ADLs) medical

Activities of daily living (ADLs) are the basic tasks a person needs to do every day to care for themselves, such as eating, bathing, dressing, using the toilet, moving around, and getting in and out of bed—think of them as a simple checklist of personal independence. Investors care because ADL status drives demand and costs for long‑term care, medical devices, home‑care services and insurance coverage, and is often used to measure treatment impact or eligibility for benefits.

psychotropic medications medical

Psychotropic medications are drugs that act on the brain to change mood, perception, thinking, or behavior; common classes include antidepressants, antipsychotics, anti-anxiety drugs, mood stabilizers and certain stimulants. They matter to investors because approval decisions, clinical trial results, safety issues, patent protections and prescribing trends directly affect sales and risk for companies that make them — like a single major product that can make or break a business.

randomized control group technical

A randomized control group is the set of participants in a clinical study who are assigned by chance to receive a placebo or standard care instead of the experimental treatment, creating a baseline for comparison. Because assignment is random, differences in outcomes are more likely caused by the treatment itself rather than other factors, making study results more credible to regulators and investors assessing a therapy’s effectiveness and commercial potential — like comparing a new recipe against the original to see if the change truly improves the dish.

gastrointestinal (GI) tolerability medical

Gastrointestinal (GI) tolerability describes how well a drug or treatment is tolerated by the stomach and intestines — essentially whether it causes nausea, vomiting, diarrhea, constipation, or other digestive upset. For investors, it matters because poor GI tolerability can limit a medicine’s use, trigger extra warnings or trials, reduce patient adherence, and shrink potential sales; think of it like a product’s comfort level that affects customer acceptance and repeat use.

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In a retrospective observational study based on provider assessments and chart review:

• Providers reported cognitive improvement in 92% of patients following initiation of ZUNVEYL
• Providers reported improvement in neuropsychiatric symptoms in 93% of patients after initiation of ZUNVEYL
• Providers reported delayed initiation or discontinuation of concomitant psychotropic medications in 80% of patients receiving ZUNVEYL
• Providers reported favorable changes in activities of daily living (ADLs) in 71% of patients following initiation of ZUNVEYL
• Providers reported improvements across sleep-related outcomes in 72% of patients following initiation of ZUNVEYL
• Providers reported favorable gastrointestinal (GI) tolerability and overall treatment experience in patients receiving ZUNVEYL

VANCOUVER, British Columbia & GRAPEVINE, Texas--(BUSINESS WIRE)-- Alpha Cognition Inc. (NASDAQ: ACOG) (“Alpha Cognition”, “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today announced the top-line results from its BEACON real-world study evaluating provider-reported cognitive, behavioral, functional, and tolerability outcomes among long-term care residents with mild to moderate Alzheimer’s disease who were receiving ZUNVEYL.

The BEACON study evaluated provider-reported outcomes from 21 investigators treating 162 long-term care patients with mild to moderate Alzheimer’s disease who received ZUNVEYL for 3 to 12 months following prior acetylcholinesterase inhibitor (AChEI) treatment or after discontinuation of available AChEI therapies presumably due to limited efficacy or tolerability.

“We believe that long-term care patients with Alzheimer’s disease remain underrepresented in traditional clinical datasets despite representing a significant and clinically complex treatment population,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “BEACON provides valuable real-world insights into the treatment experience of long-term care patients with Alzheimer’s disease receiving ZUNVEYL.”

"The importance of the BEACON study lies in its focus on the patients we care for every day in long-term care facilities—individuals with Alzheimer's disease whose cognitive decline is often accompanied by neuropsychiatric symptoms, functional impairment, and substantial medication burden,” said Erik Cabrera, MD, Board-Certified Psychiatrist and Long-Term Care Practitioner. “The provider-reported observations from BEACON provide descriptive real-world information regarding treatment experiences among long-term care patients receiving ZUNVEYL. While the study was not designed to establish causality, these findings may help inform clinical discussions and future research in this challenging patient population.”

Because BEACON was a retrospective observational study without a randomized control group, the reported observations cannot establish causality and should not be interpreted as evidence that ZUNVEYL caused the reported outcomes.

Key Findings

• 98% of providers reported a favorable overall treatment experience among patients receiving ZUNVEYL

Cognitive and Functional Reports

• Providers reported cognitive improvement in 92% of patients following ZUNVEYL treatment
• Providers reported improvement in activities of daily living (ADLs) in 71% of patients following treatment with ZUNVEYL

Neuropsychiatric and Behavioral Reports

• Providers reported improvement in neuropsychiatric symptoms in 93% of patients following ZUNVEYL administration
• These observations were provider-reported and do not establish that ZUNVEYL improves agitation, aggression, anxiety, sleep disturbances, or other neuropsychiatric symptoms

Reduction in Medication Burden

• Providers reported delaying initiation or discontinuing concomitant psychotropic medications in 80% of patients; the study was not designed to determine whether these changes were attributable to ZUNVEYL.
• Antipsychotics and anxiolytics were the medication classes most frequently reported as delayed or discontinued during the observation period

Tolerability Reports

• Providers reported improvement in sleep-related issues in 72% of affected patients after transitioning to ZUNVEYL. These observations were based on provider assessments and do not establish an effect of ZUNVEYL on sleep-related outcomes.
• When taking ZUNVEYL, providers reported favorable gastrointestinal tolerability observations in 89% of patients with a history of GI side effects while receiving prior acetylcholinesterase inhibitors.

About the BEACON Study

BEACON was a Phase IV, retrospective, observational real-world effectiveness and tolerability study designed to capture provider assessments and chart review observations in long-term care clinical practice settings. Providers participating in the BEACON study reported observations related to cognition, neuropsychiatric symptoms, medication utilization, and tolerability, which may contribute to understanding treatment experiences in complex elderly patients receiving routine clinical care.

As a retrospective observational study, BEACON was not designed to establish causality, and findings reflect provider-reported clinical experience in real-world long-term care practice settings. The findings reported in the BEACON study are subject to limitations inherent in observational research, including potential bias, confounding factors, variability in clinical practice, and the absence of randomization or a control group. As a result, provider-reported observations regarding cognition, neuropsychiatric symptoms, functional outcomes, medication utilization, tolerability, and other clinical measures may not be attributable to ZUNVEYL and may not be predictive of future clinical outcomes. There can be no assurance that the observations reported in the BEACON study will be confirmed in prospective, controlled clinical trials, will be replicated in broader patient populations, or will support future regulatory, medical, reimbursement, commercial, or clinical conclusions regarding ZUNVEYL.

About ZUNVEYL (benzgalantamine)

ZUNVEYL was designed with a differentiated metabolic profile that results in reduced gastrointestinal exposure to galantamine relative to conventional oral galantamine formulations. The clinical significance of this pharmacokinetic difference has not been established beyond findings described in the approved prescribing information.

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 acetylcholinesterase inhibitor approved for the treatment of mild-to-moderate Alzheimer's disease in adults. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, including the alpha-7 subtype, which has been studied in preclinical and clinical research. Benzgalantamine 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.

INDICATION AND USAGE

ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred.

WARNINGS AND PRECAUTIONS

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.

Anesthesia: See Drug Interactions Section

Cardiovascular Conditions: Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.

Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope.

Gastrointestinal Conditions: 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). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.

Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL

Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction.

Neurological Conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL.

Pulmonary Conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions.

ADVERSE REACTIONS

The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.

DRUG INTERACTIONS

Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications.

Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data may cause fetal harm.

Hepatic Impairment: In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended.

Renal Impairment: In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended.

These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information.

Forward-looking Statements

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. These statements include but are not limited to statements regarding the impact of provider-reported observations from the BEACON study on future care decision including the possibility to support simplified treatment management in complex elderly patients. 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. 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 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 most recent Annual Report on Form 10-K filed with the SEC on March 31, 2026 and the Company’s other filings with the SEC 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/20260609909539/en/

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

Source: Alpha Cognition Inc.