NCT02471196

Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Alzheimer's Disease

Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Patients With Alzheimer's Disease: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study of 12 Weeks

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of ORM-12741 on agitation/aggression symptoms in Alzheimer's disease. Two thirds of the patients will receive ORM-12741 and one third will receive placebo.

Detailed description

ORM-12741 is a potent and selective alpha-2C adrenoceptor (AR)-antagonist. Previous results suggest that the compound may have positive effects on both cognitive and neuropsychiatric symptoms of Alzheimer's Disease. In this study, the effect of ORM-12741 will be evaluated on agitation/aggression symptoms and other neuropsychiatric symptoms. Furthermore, cognition and psychotic and depressive symptoms will be evaluated.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ORM-12741	ORM-12741 low dose twice a day
DRUG	ORM-12741	ORM-12741 high dose twice a day
DRUG	Placebo	Placebo twice a day

Timeline

• Start date: 2015-08-14
• Primary completion: 2017-10-09
• Completion: 2017-12-04
• First posted: 2015-06-15
• Last updated: 2018-02-15

Locations

1 site across 1 country: Finland