Announcement • Jun 16
Alpha Cognition Enrolls First Patient In Resolve Phase 4 Study Evaluating Zunveyl In Patients With Mild To Moderate Alzheimer’s Disease
Alpha Cognition 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 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. 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. ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. 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. 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. 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. Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. 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. 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. The most common adverse reactions with galantamine tablets (=5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Galantamine has the potential to interfere with the activity of anticholinergic medications. 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. Based on animal data may cause fetal harm. 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. 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.
