Tests ONO-2020 for agitation in people with Alzheimer's dementia
Tests ONO-2020 against a placebo in adults with Alzheimer's-related agitation.
Plain-language title generated from the registry record
Registry title: A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Key facts
- Where
- Aichi, Akita, Aomori, Fukui, Fukuoka, Gunma, Hiroshima, Hokkaido, Kagoshima, Kanagawa, Kochi, Kyoto, Miyagi, Nagano, Nara, Osaka, Saga, Saitama, Tokyo, and Yamagata, JapanSee the 39 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
Source: NCT06803823, who can take part
Where in Japan
- Hotei HospitalAichi, JapanTaking people
- Akita Prefectural Center For Rehabilitation and Psychiatric MedicineAkita, JapanTaking people
- Medical Corporation Keishinkai Kyowa HospitalAkita, JapanTaking people
- Aiseikai General Incorporated Foundation, Hirosaki Aiseikai HospitalAomori, JapanTaking people
- Seinan HospitalAomori, JapanTaking people
- Fukui HospitalFukui, JapanTaking people
- Matsubara HospitalFukui, JapanTaking people
- Aburayama HospitalFukuoka, JapanTaking people
- Kuramitsu HospitalFukuoka, JapanTaking people
- Kishikai Kishi HospitalGunma, JapanTaking people
- Hayakawa ClinicHiroshima, JapanTaking people
- Koseikai Cocoro Hospital KusatsuHiroshima, JapanTaking people
- Nakamura HospitalHiroshima, JapanTaking people
- Keiseikai HospitalHokkaido, JapanTaking people
- NHO Obihiro National HospitalHokkaido, JapanTaking people
- Airanomori HospitalKagoshima, JapanTaking people
- Ishiki HospitalKagoshima, JapanTaking people
- Sansyu HospitalKagoshima, JapanTaking people
- Taniyama HospitalKagoshima, JapanTaking people
- FujisawahospitalKanagawa, JapanTaking people
- Hatano Kousei HospitalKanagawa, JapanTaking people
- Showa Medical University Northern Yokohama HospitalKanagawa, JapanTaking people
- Hosogi HospitalKochi, JapanTaking people
- Ichiyo Mental HospitalKochi, JapanNo longer taking part
- Maizuru Medical CenterKyoto, JapanTaking people
- Nishiyama HospitalKyoto, JapanTaking people
- Iryohojin Shadan Shoshinkai Morinohosupitaru・AobaMiyagi, JapanTaking people
- JA-Nagano North Alps Medical Center Azumi HospitalNagano, JapanTaking people
- Jizenkai Ando HospitalNagano, JapanTaking people
- Nara Medical University HospitalNara, JapanTaking people
- Nagaokai Neyagawa SanatoriumOsaka, JapanTaking people
- Osaka Institute of Clinical Psychiatry Shin-Abuyama HospitalOsaka, JapanTaking people
- Osaka Psychiatric Medical CenterOsaka, JapanTaking people
- Hizen Psychiatric CenterSaga, JapanTaking people
- Rainbow & Sea HospitalSaga, JapanTaking people
- Saitama Konan HospitalSaitama, JapanTaking people
- Asuka HospitalTokyo, JapanNo longer taking part
- Nishigahara HospitalTokyo, JapanNo longer taking part
- Sanyokai Sanyo HospitalYamagata, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT06803823
- Record updated
- 25 September 2026
- Original description
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.Read full original descriptionShow less
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
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Inclusion: 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: 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; 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.