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

May 10, 2026 updated by: Ono Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Aichi, Japan
        • Recruiting
        • Hotei Hospital
      • Akita, Japan
        • Recruiting
        • Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
      • Akita, Japan
        • Recruiting
        • Medical Corporation Keishinkai Kyowa Hospital
      • Aomori, Japan
        • Recruiting
        • Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
      • Aomori, Japan
        • Recruiting
        • Seinan Hospital
      • Fukui, Japan
        • Recruiting
        • Fukui Hospital
      • Fukui, Japan
        • Recruiting
        • Matsubara Hospital
      • Fukuoka, Japan
        • Recruiting
        • Kuramitsu Hospital
      • Fukuoka, Japan
        • Recruiting
        • Aburayama Hospital
      • Gunma, Japan
        • Recruiting
        • Kishikai Kishi Hospital
      • Hiroshima, Japan
        • Recruiting
        • Hayakawa Clinic
      • Hiroshima, Japan
        • Recruiting
        • Koseikai Cocoro Hospital Kusatsu
      • Hiroshima, Japan
        • Recruiting
        • Nakamura Hospital
      • Hokkaido, Japan
        • Recruiting
        • Keiseikai Hospital
      • Hokkaido, Japan
        • Recruiting
        • NHO Obihiro National Hospital
      • Kagoshima, Japan
        • Recruiting
        • Ishiki Hospital
      • Kagoshima, Japan
        • Recruiting
        • Airanomori Hospital
      • Kagoshima, Japan
        • Recruiting
        • Sansyu Hospital
      • Kagoshima, Japan
        • Recruiting
        • Taniyama Hospital
      • Kanagawa, Japan
        • Recruiting
        • Hatano Kousei Hospital
      • Kanagawa, Japan
        • Recruiting
        • Showa Medical University Northern Yokohama Hospital
      • Kanagawa, Japan
        • Recruiting
        • Fujisawahospital
      • Kochi, Japan
        • Recruiting
        • Hosogi Hospital
      • Kochi, Japan
        • Recruiting
        • Ichiyo Mental Hospital
      • Kyoto, Japan
        • Recruiting
        • Maizuru Medical Center
      • Kyoto, Japan
        • Recruiting
        • Nishiyama Hospital
      • Miyagi, Japan
        • Recruiting
        • Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
      • Nagano, Japan
        • Recruiting
        • JA-Nagano North Alps Medical Center Azumi Hospital
      • Nagano, Japan
        • Recruiting
        • Jizenkai Ando Hospital
      • Nara, Japan
        • Recruiting
        • Nara Medical University Hospital
      • Osaka, Japan
        • Recruiting
        • Nagaokai Neyagawa Sanatorium
      • Osaka, Japan
        • Recruiting
        • Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
      • Saga, Japan
        • Recruiting
        • Hizen Psychiatric Center
      • Saga, Japan
        • Recruiting
        • Rainbow & Sea Hospital
      • Saitama, Japan
        • Recruiting
        • Saitama Konan Hospital
      • Tokyo, Japan
        • Recruiting
        • Asuka Hospital
      • Tokyo, Japan
        • Recruiting
        • Nishigahara Hospital
      • Yamagata, Japan
        • Recruiting
        • Sanyokai Sanyo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Two ONO-2020 placebo tablets will be orally administered once daily
Experimental: ONO-2020
Drug: ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CMAI score from baseline
Time Frame: up to week 12
To assess agitation symptoms
up to week 12
Adverse events
Time Frame: up to week 16
To Evaluate the Safety
up to week 16
Body weight
Time Frame: up to week 16
To Evaluate the Safety
up to week 16
Body temperature
Time Frame: up to week 16
To Evaluate the Safety
up to week 16
Blood pressure
Time Frame: up to week 16
To Evaluate the Safety
up to week 16
Pulse rate
Time Frame: up to week 16
To Evaluate the Safety
up to week 16
Respiratory rate
Time Frame: up to week 16
To Evaluate the Safety
up to week 16
ECG RR interval
Time Frame: up to week 12
To Evaluate the Safety
up to week 12
ECG PR interval
Time Frame: up to week 12
To Evaluate the Safety
up to week 12
ECG QRS complex
Time Frame: up to week 12
To Evaluate the Safety
up to week 12
ECG QT interval
Time Frame: up to week 12
To Evaluate the Safety
up to week 12
ECG QTcF
Time Frame: up to week 12
To Evaluate the Safety
up to week 12
Number of participants with abnormal laboratory tests (hematology)
Time Frame: up to week 12
Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit)
up to week 12
Number of participants with abnormal laboratory tests (Clinical chemistry)
Time Frame: up to week 12
Clinical chemistry (Blood urea nitrogen (BUN), Potassium, Creatinine, Sodium, Glucose (fasting or nonfasting), Calcium, Chloride, Total protein, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase, Total and direct bilirubin, Lactate dehydrogenase (LDH), Phospholipid, γ-Glutamyl transferase (GGT)
up to week 12
Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
Time Frame: up to week 12
Blood coagulation (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
up to week 12
Number of participants with abnormal Urinalysis
Time Frame: up to week 12
Urinalysis (pH, Glucose, Protein, Blood, Ketones)
up to week 12
COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）
Time Frame: up to week 16
To Evaluate the Safety
up to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the investigational medicinal product administration
Time Frame: up to 12 week
To Evaluate the Efficacy
up to 12 week
Pharmacokinetic assessments
Time Frame: up to 12 week
Plasma ONO-2020 concentrations
up to 12 week
Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline
Time Frame: up to 12 week
To Evaluate the Efficacy The range of CMAI score is 29-203. Higher score means a worse outcome.
up to 12 week
Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline
Time Frame: up to 12 week
To Evaluate the Efficacy The range of CGI-S score is 0-7. Higher score means a worse outcome.
up to 12 week
Clinical Global Impression-Severity （CGI-S） score at each visit
Time Frame: up to 12 week
To Evaluate the Efficacy
up to 12 week
Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline
Time Frame: up to 12 week
To Evaluate the Efficacy The range of NPI-NH score is 0-170. Higher score means a worse outcome.
up to 12 week
Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline
Time Frame: up to 12 week
To Evaluate the Efficacy The range of MMSE score is 0-30. Higher score means a better outcome.
up to 12 week
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)score at baseline and Week 12, and change from baseline
Time Frame: up to 12 week
To Evaluate the Efficacy The range of ADCS-ADL score is 0-78. Higher score means a better outcome.
up to 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-2020-03
  • jRCT2041230153 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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