Actively Recruiting
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-05-12
90
Participants Needed
38
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of probable Alzheimer's Disease dementia according to NIA-AA 2011 criteria
- Mini-Mental State Examination (MMSE) score between 5 and 22 at treatment start
- Agitation symptoms present for at least 14 days before screening
- Neuropsychiatric Inventory-Nursing Home (NPI-NH) Agitation/Aggression score of 4 or higher at treatment start
- Ability to participate while hospitalized from 21 days before treatment start through treatment period
You will not qualify if you...
- Diagnosis of dementia not caused by Alzheimer's Disease, including mixed, vascular, Lewy body, Parkinson's disease-related, frontotemporal, drug-induced, HIV-associated, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementias
- Brain MRI or CT after dementia onset showing significant CNS diseases other than Alzheimer's, such as infarctions or tumors
- Delirium within 30 days before screening or history of delirium
- At risk of suicide based on Columbia-Suicide Severity Rating Scale or recent suicide attempt within 6 months
- Prior or current treatment with anti-amyloid beta antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Hotei Hospital
Aichi, Japan
Actively Recruiting
2
Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
Akita, Japan
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3
Medical Corporation Keishinkai Kyowa Hospital
Akita, Japan
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4
Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
Aomori, Japan
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5
Seinan Hospital
Aomori, Japan
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6
Fukui Hospital
Fukui, Japan
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7
Matsubara Hospital
Fukui, Japan
Actively Recruiting
8
Aburayama Hospital
Fukuoka, Japan
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9
Kuramitsu Hospital
Fukuoka, Japan
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10
Kishikai Kishi Hospital
Gunma, Japan
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11
Hayakawa Clinic
Hiroshima, Japan
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12
Koseikai Cocoro Hospital Kusatsu
Hiroshima, Japan
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13
Nakamura Hospital
Hiroshima, Japan
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14
Keiseikai Hospital
Hokkaido, Japan
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15
NHO Obihiro National Hospital
Hokkaido, Japan
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16
Airanomori Hospital
Kagoshima, Japan
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17
Ishiki Hospital
Kagoshima, Japan
Actively Recruiting
18
Sansyu Hospital
Kagoshima, Japan
Actively Recruiting
19
Taniyama Hospital
Kagoshima, Japan
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20
Fujisawahospital
Kanagawa, Japan
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21
Hatano Kousei Hospital
Kanagawa, Japan
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22
Showa Medical University Northern Yokohama Hospital
Kanagawa, Japan
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23
Hosogi Hospital
Kochi, Japan
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24
Ichiyo Mental Hospital
Kochi, Japan
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25
Maizuru Medical Center
Kyoto, Japan
Actively Recruiting
26
Nishiyama Hospital
Kyoto, Japan
Actively Recruiting
27
Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
Miyagi, Japan
Actively Recruiting
28
JA-Nagano North Alps Medical Center Azumi Hospital
Nagano, Japan
Actively Recruiting
29
Jizenkai Ando Hospital
Nagano, Japan
Actively Recruiting
30
Nara Medical University Hospital
Nara, Japan
Actively Recruiting
31
Nagaokai Neyagawa Sanatorium
Osaka, Japan
Actively Recruiting
32
Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
Osaka, Japan
Actively Recruiting
33
Hizen Psychiatric Center
Saga, Japan
Actively Recruiting
34
Rainbow & Sea Hospital
Saga, Japan
Actively Recruiting
35
Saitama Konan Hospital
Saitama, Japan
Actively Recruiting
36
Asuka Hospital
Tokyo, Japan
Actively Recruiting
37
Nishigahara Hospital
Tokyo, Japan
Actively Recruiting
38
Sanyokai Sanyo Hospital
Yamagata, Japan
Actively Recruiting
Research Team
N
North America Clinical Trial Support Desk
CONTACT
I
International Clinical Trial Support Desk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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