A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
A Phase 2a, Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
- Agitation Associated With Alzheimer's Disease Dementia
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Ono Pharmaceutical Co., Ltd.
- Enrolment target
- 90
- Started
- 1 May 2025
- Main results due
- 31 December 2026
- Study sites
- 39
- Registry updated
- 25 September 2026
Can you take part?
- Ages 55 years to 90 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011) * Mini-Mental State Examination (MMSE) score ≥ 5 to ≤ 22 at the start of the treatment period * Symptoms of agitation defined by the IPA from at least 14 days before the start of the screening period * Neuropsychiatric Inventory-Nursing Home version (NPI-NH) Agitation/Aggression domain (NPI-NH-A/A) score ≥ 4 at the start of the treatment period. * Patients who can participate in the study under hospitalization from 21 days before the start of the treatment period to throughout the treatment period Exclusion Criteria: * Diagnosis of dementia not due to AD or any other disorder with memory impairment, such as mixed dementia, vascular dementia, Lewy body dementia, dementia associated with Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementia associated with human immunodeficiency virus (HIV) infection, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementia * Any MRI or CT scan of the brain performed after the onset of dementia with findings consistent with clinically relevant CNS disease other than AD, such as vascular changes (eg, cortical cerebral infarction, multiple cerebral infarctions), space-occupying lesions (eg, tumors), or any other major structural brain disease * Delirium within 30 days before the start of the screening period or a history of delirium * At risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) (answers "yes" to Question 4 or 5 of the suicidal ideation section of the C-SSRS) or any suicide attempt within 6 months before the start of the screening period, or at serious risk of suicide in the opinion of the investigator or subinvestigator * Prior or current treatment with anti-amyloid beta antibodies
What this study is about
In the sponsor’s own words, from the registry.
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Study sites(39)
Hotei Hospital
Aichi, Japan
Recruiting
Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
Akita, Japan
Recruiting
Medical Corporation Keishinkai Kyowa Hospital
Akita, Japan
Recruiting
Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
Aomori, Japan
Recruiting
Seinan Hospital
Aomori, Japan
Recruiting
Fukui Hospital
Fukui, Japan
Recruiting
Matsubara Hospital
Fukui, Japan
Recruiting
Aburayama Hospital
Fukuoka, Japan
Recruiting
Kuramitsu Hospital
Fukuoka, Japan
Recruiting
Kishikai Kishi Hospital
Gunma, Japan
Recruiting
Hayakawa Clinic
Hiroshima, Japan
Recruiting
Koseikai Cocoro Hospital Kusatsu
Hiroshima, Japan
Recruiting
Nakamura Hospital
Hiroshima, Japan
Recruiting
Keiseikai Hospital
Hokkaido, Japan
Recruiting
NHO Obihiro National Hospital
Hokkaido, Japan
Recruiting
Airanomori Hospital
Kagoshima, Japan
Recruiting
Ishiki Hospital
Kagoshima, Japan
Recruiting
Sansyu Hospital
Kagoshima, Japan
Recruiting
Taniyama Hospital
Kagoshima, Japan
Recruiting
Fujisawahospital
Kanagawa, Japan
Recruiting
Hatano Kousei Hospital
Kanagawa, Japan
Recruiting
Showa Medical University Northern Yokohama Hospital
Kanagawa, Japan
Recruiting
Hosogi Hospital
Kochi, Japan
Recruiting
Ichiyo Mental Hospital
Kochi, Japan
Terminated
Maizuru Medical Center
Kyoto, Japan
Recruiting
Nishiyama Hospital
Kyoto, Japan
Recruiting
Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
Miyagi, Japan
Recruiting
JA-Nagano North Alps Medical Center Azumi Hospital
Nagano, Japan
Recruiting
Jizenkai Ando Hospital
Nagano, Japan
Recruiting
Nara Medical University Hospital
Nara, Japan
Recruiting
Nagaokai Neyagawa Sanatorium
Osaka, Japan
Recruiting
Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
Osaka, Japan
Recruiting
Osaka Psychiatric Medical Center
Osaka, Japan
Recruiting
Hizen Psychiatric Center
Saga, Japan
Recruiting
Rainbow & Sea Hospital
Saga, Japan
Recruiting
Saitama Konan Hospital
Saitama, Japan
Recruiting
Asuka Hospital
Tokyo, Japan
Terminated
Nishigahara Hospital
Tokyo, Japan
Terminated
Sanyokai Sanyo Hospital
Yamagata, Japan
Recruiting
Showing 39 of 39 sites. 36 of the 39 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06803823. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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