Alpha Cognition has started enrolling patients in its RESOLVE Phase IV post-marketing study, which is evaluating the tolerability and real-world treatment experience of Zunveyl (benzgalantamine) in patients with mild-to-moderate Alzheimer’s disease.
The multi-centre, post-approval trial will collect tolerability and safety data on Zunveyl, focusing on patients diagnosed with Alzheimer’s and will also monitor Alzheimer’s-related neuropsychiatric symptoms in an outpatient context.
The study aims to enrol 150 patients across multiple sites. Researchers will monitor adverse events, treatment persistence, and discontinuation rates throughout the duration of the study.
The safety and effectiveness data from RESOLVE will complement previously gathered clinical evidence and further inform the use of Zunveyl in the treatment of Alzheimer’s disease.
Alpha Cognition expects patient enrolment to continue through the second quarter of 2027, with top line results to be revealed after the completion of study enrolment and follow-up.
Separately, Alpha Cognition focuses on developing therapies for neurodegenerative conditions, including cognitive impairment with mild traumatic brain injury (mTBI), an area with no approved treatment.
Zunveyl is an acetylcholinesterase inhibitor approved by the US Food and Drug Administration (FDA) for mild-to-moderate Alzheimer’s in adults.
The company is also developing ALPHA-1062 as a sublingual formulation for patients with difficulty swallowing and as a potential treatment for cognitive impairment associated with mTBI.
Alpha Cognition medical affairs vice-president Kurt Grady said: “The approval of Zunveyl marked an important step forward, but our responsibility to patients and healthcare providers does not end with approval.
“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.”
Earlier this month, Alpha Cognition reported positive top line data from the BEACON real-world study assessing provider-reported outcomes for long-term care residents with mild-to-moderate Alzheimer’s treated with Zunveyl.
