Study reports Alzheimer’s treatment gains in long-term care
Provider observations with Zunveyl cannot prove cause and effect
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Top-line data from a real-world study suggest that Zunveyl (benzgalantamine) was associated with provider-reported improvements in cognition, behavioral symptoms, daily functioning, and overall treatment experience in people with mild-to-moderate Alzheimer’s disease.
The BEACON study evaluated provider-reported outcomes from 21 investigators treating 162 long-term care patients who received routine clinical care with Zunveyl for three months to a year.
“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,” Michael McFadden, CEO of Alpha Cognition, the company that developed Zunveyl, said in a company press release. “BEACON provides valuable real-world insights into the treatment experience of long-term care patients with Alzheimer’s disease receiving ZUNVEYL.”
Zunveyl studied in long-term care
Erik Cabrera, MD, board-certified psychiatrist and long-term care practitioner, added that “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.”
Zunveyl, previously known as ALPHA-1062, is an oral delayed-release formulation of benzgalantamine, a prodrug of galantamine, approved to treat adults with mild-to-moderate Alzheimer’s. Once inside the body, it is converted into galantamine. Galantamine, also approved to treat Alzheimer’s, works by helping increase the availability of acetylcholine, a brain signaling molecule involved in learning, thinking, and memory.
FDA’s approval of Zunveyl was based on bioequivalence studies in healthy volunteers, which demonstrated that it delivers levels of galantamine to the body equivalent to those of its reference treatment. Zunveyl is designed to remain inactive as it passes through the stomach and is later converted into galantamine, which may improve its tolerability profile and reduce gastrointestinal symptoms associated with galantamine treatment.
The BEACON study was a Phase 4 retrospective observational study designed to capture real-world evidence, reflecting how the therapy performs in everyday clinical practice. It evaluated provider-reported outcomes in long-term care patients with mild-to-moderate Alzheimer’s treated with Zunveyl after prior treatment with acetylcholinesterase inhibitors, the class of Alzheimer’s therapies to which Zunveyl belongs.
As a retrospective observational study, BEACON was not designed to establish causality. Still, across treated individuals, providers reported improvements in multiple areas affected by Alzheimer’s disease.
Providers report gains with treatment
Nearly all providers (98%) reported an overall favorable treatment experience with Zunveyl. Providers reported cognitive improvements in 92% of patients, while 71% had favorable observations related to activities of daily living after starting treatment.
Providers also reported improvements in neuropsychiatric symptoms in 93% of those treated with Zunveyl. They also reported delayed initiation or discontinuation of concomitant psychotropic medications, including antipsychotics and anxiolytics, in 80% of patients. Providers also reported improvement in sleep-related issues in 72% of affected patients.
Among those who had experienced gastrointestinal side effects with previous acetylcholinesterase inhibitors, providers reported favorable gastrointestinal tolerability observations in 89% after treatment with Zunveyl.
“The provider-reported observations from BEACON provide descriptive real-world information regarding treatment experiences among long-term care patients receiving ZUNVEYL,” Cabrera said. “While the study was not designed to establish causality, these findings may help inform clinical discussions and future research in this challenging patient population.”
Alpha Cognition has now initiated RESOLVE, a Phase 4 (NCT07633470) study evaluating Zunveyl in people with mild-to-moderate Alzheimer’s disease, with the first participant recently enrolled. The trial will further evaluate Zunveyl’s tolerability profile and treatment experience in routine clinical practice, while also exploring changes in Alzheimer’s-related neuropsychiatric symptoms. Alpha Cognition said data from the study could support future regulatory discussions and help inform physicians and payers about Zunveyl’s tolerability profile.
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