Alpha Cognition Announces First Patient Enrolled in RESOLVE Phase 4 Study Evaluating ZUNVEYL® in Patients with Mild to Moderate Alzheimer’s Disease

Key Terms

phase 4 medical

Phase 4 is the stage after a drug or vaccine has been approved and is sold to the public, where regulators and companies keep watching how it performs in the real world to detect rare side effects, long‑term effects, or differences in effectiveness across different groups. Think of it as ongoing quality control for a product already on shelves; results can prompt label changes, safety warnings, sales impacts or recalls, all of which matter to investors evaluating risk and future revenue.

post-marketing medical

Post-marketing describes the period after a drug, medical device, or other regulated product has been approved and is being sold to the public, during which companies and regulators monitor how it performs in real-world use. Like a car owner tracking performance and repairs after buying a new model, post-marketing activities — such as safety monitoring, additional studies, and reporting of side effects — matter to investors because they can reveal unexpected risks, trigger label changes, recalls, or costly follow-up studies that affect sales and valuation.

tolerability profile medical

A tolerability profile is the overall record of side effects and how well people can use a medical treatment without stopping or reducing it. Like a comfort rating for a product, it summarizes how often unwanted reactions occur, how severe they are, and whether they force people to quit, and investors watch it because a poor profile can limit regulatory approval, patient uptake, market size, and future sales.

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.

adverse events medical

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

outpatient setting medical

Care provided to patients who receive medical tests, treatments, or consultations without staying overnight in a hospital; examples include clinic visits, same-day procedures, or diagnostic testing centers. For investors, the outpatient setting matters because it often lowers costs, speeds patient throughput, and exposes companies to different reimbursement rules and volume-driven revenue models—think of it like a walk-in store versus a hotel stay for medical services.

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VANCOUVER, British Columbia & GRAPEVINE, Texas--(BUSINESS WIRE)-- Alpha Cognition, Inc. (ACOG: NASDAQ) (“Alpha Cognition” or the “Company”), a biopharmaceutical company dedicated to developing innovative therapies for neurodegenerative diseases, today announced the enrollment of the first patient in RESOLVE, a Phase 4 post-marketing clinical study designed to further evaluate the tolerability profile and treatment experience associated with ZUNVEYL in routine clinical practice.

RESOLVE is a multicenter, post-approval Phase 4 study designed to further evaluate the tolerability profile of ZUNVEYL in clinical practice, in patients with Alzheimer's disease. The study will collect safety and tolerability data and will also explore changes in Alzheimer's disease-related neuropsychiatric symptoms in an outpatient setting among patients receiving ZUNVEYL.

“The approval of ZUNVEYL marked an important step forward, but our responsibility to patients and healthcare providers does not end with approval,” said Kurt Grady, Vice President of Medical Affairs at Alpha Cognition. “RESOLVE reflects our commitment to continuing to learn from real-world clinical practice and to generating evidence that helps physicians make informed treatment decisions for patients living with Alzheimer’s disease.”

The RESOLVE study is expected to enroll approximately 150 patients across multiple clinical sites and will monitor adverse events, treatment persistence, and discontinuation rates throughout the study. Data generated from RESOLVE is expected to complement findings from previous clinical studies and contribute to the growing body of evidence supporting the use of ZUNVEYL in clinical practice.

Alpha Cognition expects patient enrollment to continue through the second quarter of 2027, with topline results anticipated following completion of enrollment and study follow-up.

About Alpha Cognition Inc.

Alpha Cognition Inc. is a 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® (benzgalantamine) is an FDA-approved acetylcholinesterase inhibitor indicated for the treatment of mild to moderate Alzheimer's disease. ALPHA-1062 is also being developed as a sublingual formulation for individuals who have difficulty swallowing traditional tablets and is being investigated as a potential treatment for cognitive impairment associated with mild traumatic brain injury.

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 continued enrollment in the RESOLVE study, timing for completion of enrollement, timing and results of the RESOLVE study and other related statements regarding the RESOLVE study. 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/20260616546831/en/

For further information:
Michael McFadden, CEO
Tel: 1-858-344-4375
info@alphacognition.com

Source: Alpha Cognition, Inc.