A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Recruiting · NCT06803823 · Interventional (participants receive a specific treatment) · Lead sponsor: Ono Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
ONO-2020Placebo
What this trial is about
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Who can take part
Age range
55 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
38 locations listed.
- Hotei Hospital - Aichi, Japan
- Akita Prefectural Center For Rehabilitation and Psychiatric Medicine - Akita, Japan
- Medical Corporation Keishinkai Kyowa Hospital - Akita, Japan
- Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital - Aomori, Japan
- Seinan Hospital - Aomori, Japan
- Fukui Hospital - Fukui, Japan
- Matsubara Hospital - Fukui, Japan
- Aburayama Hospital - Fukuoka, Japan
- Kuramitsu Hospital - Fukuoka, Japan
- Kishikai Kishi Hospital - Gunma, Japan
- Hayakawa Clinic - Hiroshima, Japan
- Koseikai Cocoro Hospital Kusatsu - Hiroshima, Japan
- Nakamura Hospital - Hiroshima, Japan
- Keiseikai Hospital - Hokkaido, Japan
- NHO Obihiro National Hospital - Hokkaido, Japan
- Airanomori Hospital - Kagoshima, Japan
- Ishiki Hospital - Kagoshima, Japan
- Sansyu Hospital - Kagoshima, Japan
- Taniyama Hospital - Kagoshima, Japan
- Fujisawahospital - Kanagawa, Japan
- Hatano Kousei Hospital - Kanagawa, Japan
- Showa Medical University Northern Yokohama Hospital - Kanagawa, Japan
- Hosogi Hospital - Kochi, Japan
- Ichiyo Mental Hospital - Kochi, Japan
- Maizuru Medical Center - Kyoto, Japan
- Nishiyama Hospital - Kyoto, Japan
- Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba - Miyagi, Japan
- JA-Nagano North Alps Medical Center Azumi Hospital - Nagano, Japan
- Jizenkai Ando Hospital - Nagano, Japan
- Nara Medical University Hospital - Nara, Japan
- Nagaokai Neyagawa Sanatorium - Osaka, Japan
- Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital - Osaka, Japan
- Hizen Psychiatric Center - Saga, Japan
- Rainbow & Sea Hospital - Saga, Japan
- Saitama Konan Hospital - Saitama, Japan
- Asuka Hospital - Tokyo, Japan
- Nishigahara Hospital - Tokyo, Japan
- Sanyokai Sanyo Hospital - Yamagata, Japan