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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it has initiated a Phase II feasibility trial designed to examine the efficacy and safety of pimavanserin as a treatment for patients with Alzheimer’s disease psychosis (ADP). No drug is approved in the United States to treat ADP and the off-label use of current antipsychotics is linked to increased mortality, serious adverse events, and cognitive decline in elderly patients with dementia-related psychosis.
“The development of psychosis and related behavioral disturbances in patients with Alzheimer’s disease carries a poor prognosis and often has a devastating impact on both patients and their caregivers,” said Clive Ballard, M.D., Professor of Age Related Diseases at King’s College London. “Finding new therapies that can effectively treat ADP without compromising safety is an important priority for the neurology community and society as a whole. Pimavanserin’s attractive efficacy, tolerability and safety profile observed in a Phase III trial in patients with Parkinson’s disease psychosis suggests that it may offer the potential for an important new therapeutic advance for patients suffering from ADP.”
The Phase II feasibility trial, referred to as the -019 Study, is a randomized, double-blind, placebo-controlled study designed to examine the efficacy and safety of pimavanserin in about 200 patients with ADP. The study is being conducted through a large network of research care homes established as part of the National Institute for Health Research (NIHR) Maudsley Biomedical Research Unit. Following a screening period that includes brief psycho-social therapy, patients will be randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for 12 weeks. The -019 Study will assess several key efficacy endpoints, including use of the Neuropsychiatric Inventory - Nursing Home (NPI-NH) scale to measure psychosis (hallucinations and delusions), agitation/aggression, and sleep/nighttime behavior, as well as use of the Cohen-Mansfield Agitation Inventory - Short Form (CMAI-SF) scale and the Alzheimer’s Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale. Key efficacy endpoints will be based on the change at week six from baseline. The study will also assess additional exploratory endpoints, including the cognitive status of patients using the Mini-Mental State Examination (MMSE) scale, and the durability of response to pimavanserin through twelve weeks of therapy.