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

NCT ID: NCT06803823
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Ono Pharmaceutical Co., Ltd.
Conditions: Agitation Associated With Alzheimer's Disease Dementia

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 90 participants (Estimated).

What is being studied

Drug: ONO-2020
Drug: Placebo

Who may be eligible

Ages: 55 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

39 study locations are listed.

Recruiting site status is explicitly provided for 39 locations; 36 are listed as Recruiting.

Countries: Japan

Sample of listed locations

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

Study details

Start date: May 1, 2025
Primary completion date: December 31, 2026
Completion date: March 31, 2027
First posted: January 31, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06803823
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06803823 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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