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news.Acadia Pharmaceuticals has started SERENE, a Phase II study with pimavanserin for the treatment of agitation in patients with Alzheimer’s disease (AD Agitation).
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There is currently no drug approved by the FDA for the treatment of AD Agitation. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors, with a distinct mechanism of action compared to other currently available medicines used off-label to treat AD Agitation.
Acadia executive vice president, head of research and development Serge Stankovic said: “AD Agitation is a common condition and a major cause of distress for Alzheimer’s patients, their families and caregivers.
“It also is associated with more rapid decline and earlier institutionalization of patients with AD Agitation. With no FDA-approved therapy for AD Agitation, there is a large, unmet need for a new treatment option for patients.”
About the SERENE Study
SERENE is a Phase II, randomized, double-blind, placebo-controlled, multi-center outpatient study designed to examine the efficacy and safety of pimavanserin in approximately 430 patients with Alzheimer’s disease who have agitation and/or aggression symptoms. Patients will be randomized to receive once daily oral doses of 34 mg pimavanserin, 20 mg pimavanserin or placebo for 12 weeks.
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.
About 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.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in AD Agitation. Pimavanserin is being evaluated in an extensive clinical development program by ACADIA across multiple indications.
Pimavanserin (34 mg) was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID™. NUPLAZID is not approved for the treatment of AD Agitation.