Axsome launches phase 2/3 trial of AXS-05 for agitation in Alzheimer’s

Axsome Theraputics recently announced the initiation of a phase 2/3 trial assessing efficacy and safety of AXS-05, a combination of dextromethorphan and bupropion, for agitation in Alzheimer’s disease.

“Agitation is one of the most distressing and difficult-to-treat behavioral symptoms in patients with Alzheimer’s disease,” Jeffrey Cummings, MD, ScD, of Cleveland Clinic Lerner College of Medicine, said in a press release. “It is common, being reported in about half of patients, is one of the primary reasons for early nursing home placement, and is associated with increased mortality. NMDA receptor antagonism, sigma-1 receptor agonism, and serotonin and norepinephrine reuptake inhibition may be relevant mechanisms in this condition. New treatments are needed for agitation and progress in this area is a welcome advance.”

The Addressing Dementia Via Agitation-Centered Evaluation 1 (ADVANCE-1) study will enroll approximately 435 individuals with agitation associated with Alzheimer’s disease. Study participants will be randomly assigned to receive AXS-05, bupropion, or placebo for 5 weeks. The primary efficacy measure will be the Cohen-Mansfield Agitation Inventory.

“Agitation places a heavy burden on patients with Alzheimer’s disease and their caregivers,” said Marc Agronin, MD, of Miami Jewish Health and the University of Miami Miller School of Medicine, said in the release. “Unfortunately there is currently no FDA-approved medication for this condition. The mechanisms of action of AXS-05 may hold promise in treating Alzheimer’s agitation. We look forward to learning more about AXS-05 and its potential to relieve the symptoms of agitation through the ADVANCE-1 trial.”