A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Agitation Associated With Alzheimer's Disease Dementia

In brief

To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.

Key facts

Study ID

NCT06803823

Run by

Ono Pharmaceutical Co., Ltd.

People needed

90

Starts

2025-05-01

Expected to finish

2027-03-31

Last updated by the study team

2026-05-12

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Hotei Hospital — Aichi, Japan (enrolling)
• Akita Prefectural Center For Rehabilitation and Psychiatric Medicine — Akita, Japan (enrolling)
• Medical Corporation Keishinkai Kyowa Hospital — Akita, Japan (enrolling)
• Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital — Aomori, Japan (enrolling)
• Seinan Hospital — Aomori, Japan (enrolling)
• Fukui Hospital — Fukui, Japan (enrolling)
• Matsubara Hospital — Fukui, Japan (enrolling)
• Aburayama Hospital — Fukuoka, Japan (enrolling)
• Kuramitsu Hospital — Fukuoka, Japan (enrolling)
• Kishikai Kishi Hospital — Gunma, Japan (enrolling)
• Hayakawa Clinic — Hiroshima, Japan (enrolling)
• Koseikai Cocoro Hospital Kusatsu — Hiroshima, Japan (enrolling)
• Nakamura Hospital — Hiroshima, Japan (enrolling)
• Keiseikai Hospital — Hokkaido, Japan (enrolling)
• NHO Obihiro National Hospital — Hokkaido, Japan (enrolling)
• Airanomori Hospital — Kagoshima, Japan (enrolling)
• Ishiki Hospital — Kagoshima, Japan (enrolling)
• Sansyu Hospital — Kagoshima, Japan (enrolling)
• Taniyama Hospital — Kagoshima, Japan (enrolling)
• Fujisawahospital — Kanagawa, Japan (enrolling)
• Hatano Kousei Hospital — Kanagawa, Japan (enrolling)
• Showa Medical University Northern Yokohama Hospital — Kanagawa, Japan (enrolling)
• Hosogi Hospital — Kochi, Japan (enrolling)
• Ichiyo Mental Hospital — Kochi, Japan (enrolling)
• Maizuru Medical Center — Kyoto, Japan (enrolling)

Full record on ClinicalTrials.gov

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