P20: Evaluating xanomeline and trospium as a treatment for psychosis associated with Alzheimer’s disease: design of the phase 3, ADEPT-1, relapse prevention study

Background: There are no approved treatments for Alzheimer’s disease psychosis (ADP). Xanomeline, a brain- penetrant M1/M4 preferring muscarinic receptor agonist, showed antipsychotic efficacy in placebo-controlled trials in subjects with AD Bodick NC et al. 1997; DOI: 10.1001/archneur.1997.00550160091022. Despite promising efficacy, further development of xanomeline was limited by cholinergic adverse events. The investigational antipsychotic xanomeline and trospium combines xanomeline with trospium, an FDA-approved muscarinic receptor antagonist that does not measurably cross the blood-brain barrier.