Actively Recruiting
Phase 2a Study of ONO-2020 to Treat Agitation in Alzheimers Disease Dementia Patients in Japan
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-05-12
90
Participants Needed
38
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ONO-2020 in adults aged 55 to 90 years with agitation linked to Alzheimers Disease dementia. This phase 2a, randomized, placebo-controlled study is conducted across multiple centers in Japan and aims to better understand how ONO-2020 affects agitation symptoms in this population. Participants will be randomly assigned to receive either two ONO-2020 tablets or two placebo tablets once daily. The treatment period lasts up to 12 weeks, during which patients are hospitalized from 21 days before treatment starts through the treatment phase. The study is designed as a double-blind, parallel-group trial to compare ONO-2020 against placebo. Throughout the study, researchers will monitor changes in agitation using the Cohen-Mansfield Agitation Inventory CMAI and assess safety through vital signs, ECG measurements, laboratory tests, and the Columbia-Suicide Severity Rating Scale. Additional assessments include cognitive function tests and daily living activity scores. The study will continue safety monitoring up to 16 weeks, with the primary evaluation of agitation changes by week 12.
CONDITIONS
Brief Title
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Research Team
N
North America Clinical Trial Support Desk
I
International Clinical Trial Support Desk
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
