The Phase II -019 Study was a double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of pimavanserin in 181 patients with Alzheimer's disease psychosis.
Pimavanserin met the primary endpoint in the study, showing a statistically significant reduction in psychosis versus placebo as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH).
No detrimental effect was observed on cognition for pimavanserin-treated patients compared to placebo. Atypical antipsychotics have been associated with a statistically significant acceleration of cognitive deterioration in patients with Alzheimer's disease.
Data presented at CTAD from a pre-specified subgroup analysis demonstrated a substantively larger and significant reduction in psychosis in pimavanserin-treated patients with more severe psychosis, further underscoring the effect seen on the primary result.
Pimavanserin, a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors thought to play an important role in dementia-related psychosis, is being evaluated in an extensive clinical development program by Acadia across multiple indications.
Acadia is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders.
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