Phase 2 study of Alzheimer’s disease psychosis therapy initiated

A phase 2 clinical trial has been initiated to evaluate the safety and efficacy of an inverse agonist for hallucinations and delusions associated with Alzheimer’s disease psychosis, according to the manufacturer.

According to a release from Acadia Pharmaceuticals, that the global, multicenter, randomized, double-blind, placebo-controlled trial will be the first part of a program expected to include two nearly identical phase 3 studies. The current clinical trial will enroll approximately 318 patients and evaluate ACP-204 at doses of 30 mg and 60 mg doses compared with placebo, with a primary endpoint of change from baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions total score after week 6.

Acadia further revealed in the release that its clinical trial sites will enroll seamlessly from phase 2 into phase 3, with the planned phase 3 studies aiming to enroll approximately 378 patients with AD psychosis. Individuals who complete the study will have the option of participating in a long-term open-label extension.

“Our advancement of the ACP-204 clinical program builds upon our deep understanding of both the mechanistic role for this molecule as well as the needs of the Alzheimer’s disease community,” Steve Davis, Acadia’s president and CEO, stated in the release.