Pimavanserin – Alzheimer’s Disease Agitation
Pimavanserin is a proprietary small molecule that we have advanced to Phase II development for AD Agitation. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors, with a distinct mechanism of action compared to other available medicines that are currently used off-label to treat AD Agitation.
Alzheimer’s Disease Agitation (AD Agitation)
According to the Alzheimer’s Association, around 5.4 million people in the United States are living with Alzheimer’s disease and approximately half are diagnosed with the disease. Studies suggest that 40 to 50 percent of patients diagnosed with Alzheimer’s disease in the United States exhibit agitation. AD Agitation is characterized by verbal aggression, physical aggression, and excessive motor activities. These behavioral symptoms have been associated with more rapid cognitive decline, greater caregiver burden, and earlier institutionalization.
We are currently conducting a Phase II trial, referred to as the SERENE Study, designed to examine the efficacy and safety of pimavanserin as a treatment for AD Agitation. The SERENE Study is a randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of pimavanserin in approximately 430 patients with AD Agitation. The primary endpoint in the study is a reduction in total score on the Cohen-Mansfield Agitation Inventory (CMAI). Following participation in SERENE, patients will be eligible to enroll in an open-label safety extension study.