A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
NCT ID: NCT06803823
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-05-01
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ONO-2020
ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
Placebo
Placebo
Two ONO-2020 placebo tablets will be orally administered once daily
Interventions
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Placebo
Two ONO-2020 placebo tablets will be orally administered once daily
ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
90 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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jRCT2041230153
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-2020-03
Identifier Type: -
Identifier Source: org_study_id