Alpha Cognition Announces CONVERGE Real-World Evidence on ZUNVEYL®(Benzgalantamine) Use in Long-Term Care
ZUNVEYL residents discontinued about twice as many other medication classes as they added over the 180-day analysis.
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Key CONVERGE Findings
Titration comparisons: p<0.0001. Each unadjusted between-group comparison of net concomitant medication-class burden was p<0.0001.
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Among residents who had not previously received an AChEI and started treatment at the initial dose,
79.1% of ZUNVEYL residents reached a therapeutic dose, compared with37.3% receiving generic AChEIs. -
Approximately
80% of ZUNVEYL residents reached a therapeutic dose whether they were new to AChEI treatment or had switched from another AChEI, compared with approximately54% of residents receiving generic AChEIs. - ZUNVEYL residents discontinued about twice as many other medication classes as they added, resulting in net decreases across all eight classes evaluated. In contrast, residents receiving generic AChEIs added more than twice as many medication classes as they discontinued, with net increases across all eight classes. The classes included antidepressants, antipsychotics, anxiolytics, hypnotics, miscellaneous CNS agents, OTC gastrointestinal medications, OTC sleep aids and prescription gastrointestinal medications.
CONVERGE Measure (180 Day) |
ZUNVEYL Cohort |
Pooled Generic AChEI Cohort |
Starting-dose, new to AChEI treatment: reached therapeutic dose |
|
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All-dose, new to AChEI treatment: reached therapeutic dose |
|
|
All-dose, previously treated with another AChEI: reached therapeutic dose |
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|
Net concomitant medication-class burden |
Decrease across all 8 classes |
Increase across all 8 classes |
“We are encouraged by the CONVERGE findings across these first two measures: therapeutic dosing and changes in concomitant medication use,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “The ability to reach a therapeutic dose is an important real-world indicator of successful treatment utilization, and understanding changes in medication burden is particularly relevant in long-term care, where polypharmacy is an important consideration. These initial findings are encouraging, and we look forward to analyzing additional measures as the CONVERGE dataset continues to grow.”
About CONVERGE
CONVERGE is an ongoing real-world evidence evaluation program utilizing longitudinal long-term care medication-administration data. The current analysis used PointClickCare long-term care medication-administration data through June 30, 2026. Pooled generics combined donepezil, galantamine and rivastigmine. Additional dataset updates are expected in December 2026 and March 2027 and are anticipated to expand the number of ZUNVEYL-treated residents available for future analyses. CONVERGE does not establish causality. The analyses were unadjusted for differences in resident characteristics, disease severity, treatment selection, facility practices or other potential confounders. Statistical tests reported in this release were not adjusted for multiple comparisons unless expressly stated otherwise.
About ZUNVEYL
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 (≥
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.
About Alpha Cognition Inc.
Alpha Cognition Inc. is a commercial-stage biopharmaceutical company dedicated to developing treatments for patients with neurodegenerative diseases, including Alzheimer's disease and cognitive impairment associated with mild traumatic brain injury.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the interpretation and potential relevance of CONVERGE and other real-world evidence; the potential benefits, characteristics and market adoption of ZUNVEYL; and the Company's evidence-generation, clinical-development and commercialization plans. Forward-looking statements are based on management's current expectations, assumptions and beliefs and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. These risks include risks related to the interpretation, completeness and generalizability of retrospective real-world data; confounding, selection bias, data quality and differences among treatment cohorts; commercial adoption, reimbursement, manufacturing and supply; regulatory oversight and pharmacovigilance; clinical-development timing and outcomes; intellectual property; liquidity and financing; and other risks described in the Company's filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this release. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement.
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For further information:
Investor Relations
LifeSci Advisors
PJ Kelleher
pkelleher@lifesciadvisors.com
Source: Alpha Cognition Inc.