RecruitingPhase 2NCT06803823

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

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

Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

90 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Agitation Associated With Alzheimer's Disease Dementia

Summary

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

Eligibility

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ONO-2020 to see if it can help reduce agitation and aggression in people living with Alzheimer's disease dementia. Participants will need to stay in a care facility during the treatment period. **You may be eligible if...** - You have been diagnosed with Alzheimer's disease dementia - You have moderate memory loss (based on a standard test score between 5 and 22) - You have been experiencing agitation or aggression for at least 2 weeks - You are able to stay at a care facility throughout the treatment period **You may NOT be eligible if...** - Your dementia is caused by something other than Alzheimer's (such as vascular dementia, Lewy body disease, or Parkinson's) - A brain scan has shown other significant brain problems unrelated to Alzheimer's - You have had an episode of delirium (sudden severe confusion) in the past month - You have had thoughts of suicide in the past 6 months - You are currently receiving or have previously received anti-amyloid antibody treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONO-2020

ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.

DRUGPlacebo

Two ONO-2020 placebo tablets will be orally administered once daily

Locations(38)

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

View Full Details on ClinicalTrials.gov

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