Policy & Regulation
Acadia Pharmaceuticals announces start of Phase 2 trial for ACP-204 to treat Alzheimer's disease psychosis
27 November 2023 -

Neuroscience company Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) disclosed on Monday that it has commenced a Phase 2 clinical trial for ACP-204, targeting hallucinations and delusions linked to Alzheimer's disease psychosis (ADP).

Over 6.5 million Americans with Alzheimer's face psychosis, affecting 30%. The company's global Phase 2 trial includes 318 patients assessing ACP-204 doses (30 mg and 60 mg) versus placebo, focusing on the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions subscales (SAPS-H+D) total score at Week 6.

This trial seamlessly transitions into two Phase 3 studies, each enrolling about 378 ADP patients. Participants completing the study may join a long-term open-label extension.

Alzheimer's disease psychosis, impacting 30% of AD patients, lacks FDA-approved drugs. ACP-204, an inverse agonist at the 5-HT2A receptor, addresses this unmet medical need, highlighting Acadia's commitment to advancing neuroscience breakthroughs for conditions like schizophrenia, Prader-Willi syndrome and neuropsychiatric symptoms in CNS disorders.