Efficacy of ORM‐12741 on agitation/aggression symptoms in participants with Alzheimer's disease
Juha O Rinne, Jeffrey L Cummings, Dagmar Breznoscakova, Pasi Hakulinen, Jutta Hänninen, Pascal Goetghebeur, David S Miller, Juha RouruAbstract
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.