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The patient was an 80-year-old male with multiple comorbidities, including diabetes mellitus controlled with a sodium-glucose cotransporter-2 inhibitor (SGLT2i), hypertension and coronary artery disease, for which he underwent stenting in October 2023. He also had a pacemaker implanted for heart block. His left ventricular ejection fraction (LVEF) ranged between 40–50 percent. For several years, he had been managed as an outpatient for mild heart failure (HF) symptoms and maintained independence in activities of daily living (ADL).

Treatment with AXS-05 significantly delayed the time to relapse of agitation in patients with Alzheimer’s disease (AD) compared with placebo, according to the phase III ACCORD-2 trial presented at AAN 2025.