Work

Efficacy of ORM‐12741 on agitation/aggression symptoms in participants with Alzheimer's disease

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: INTRODUCTION: ORM-12741 is a potent and selective alpha-2C adrenoceptor antagonist. The primary objective of this study was to evaluate the efficacy of ORM-12741 in treating agitation/aggression symptoms in patients with Alzheimer's disease (AD). METHODS: This was a phase II, double-blind, placebo-controlled study of 308 community-dwelling participants with mild to moderate AD (Mini-Mental State Examination [MMSE] scores 10 to 24) and Neuropsychiatric Inventory agitation/aggression scores of ≥4. Participants were randomized to 60 or 120 mg of ORM-12741 or placebo twice daily for 12 weeks. Efficacy was assessed primarily with the sum of Neuropsychiatric Inventory Clinician Rating (NPI-C) Agitation and Aggression domain scores. In addition, effects on cognition, psychotic, depressive, and overall neuropsychiatric symptoms were assessed. RESULTS: No relevant treatment effects as compared to placebo group were detected on either the primary or secondary efficacy measures. ORM-12741 was generally well tolerated. DISCUSSION: The study does not support the efficacy of ORM-12741 on agitation/aggression symptoms in patients with AD.

Source: Alzheimer s & Dementia Translational Research & Clinical Interventions

DOI: 10.1002/trc2.70332