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

NCT06803823 | Recruiting Phase 2

• 2 other identifiers: ONO-2020-03jRCT2041230153
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 38

Brief Summary

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

Conditions

Agitation Associated With Alzheimer's Disease Dementia

Outcome Measures

Primary Outcomes (17)

• Change in CMAI score from baseline

  To assess agitation symptoms

  up to week 12

• Adverse events

  To Evaluate the Safety

  up to week 16

• Body weight

  To Evaluate the Safety

  up to week 16

• Body temperature

  To Evaluate the Safety

  up to week 16

• Blood pressure

  To Evaluate the Safety

  up to week 16

• Pulse rate

  To Evaluate the Safety

  up to week 16

• Respiratory rate

  To Evaluate the Safety

  up to week 16

• ECG RR interval

  To Evaluate the Safety

  up to week 12

• ECG PR interval

  To Evaluate the Safety

  up to week 12

• ECG QRS complex

  To Evaluate the Safety

  up to week 12

• ECG QT interval

  To Evaluate the Safety

  up to week 12

• ECG QTcF

  To Evaluate the Safety

  up to week 12

• Number of participants with abnormal laboratory tests (hematology)

  Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit)

  up to week 12

• Number of participants with abnormal laboratory tests (Clinical chemistry)

  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))

  Blood coagulation (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))

  up to week 12

• Number of participants with abnormal Urinalysis

  Urinalysis (pH, Glucose, Protein, Blood, Ketones)

  up to week 12

• COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）

  To Evaluate the Safety

  up to week 16

Secondary Outcomes (8)

• Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline

  up to 12 week

• Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline

  up to 12 week

• Clinical Global Impression-Severity （CGI-S） score at each visit

  up to 12 week

• Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline

  up to 12 week

• Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline

  up to 12 week

Study Arms (2)

ONO-2020

EXPERIMENTAL

Drug: ONO-2020

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ONO-2020 DRUG

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

ONO-2020

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (38)

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

NOT YET RECRUITING

Ishiki Hospital

Kagoshima, Japan

RECRUITING

Sansyu Hospital

Kagoshima, Japan

NOT YET RECRUITING

Taniyama Hospital

Kagoshima, Japan

NOT YET 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

Ichiyo Mental Hospital

Kochi, Japan

RECRUITING

Maizuru Medical Center

Kyoto, Japan

RECRUITING

Nishiyama Hospital

Kyoto, Japan

NOT YET RECRUITING

Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba

Miyagi, Japan

RECRUITING

JA-Nagano North Alps Medical Center Azumi Hospital

Nagano, Japan

RECRUITING

Jizenkai Ando Hospital

Nagano, Japan

RECRUITING

Nara Medical University Hospital

Nara, Japan

NOT YET RECRUITING

Nagaokai Neyagawa Sanatorium

Osaka, Japan

RECRUITING

Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital

Osaka, Japan

RECRUITING

Hizen Psychiatric Center

Saga, Japan

RECRUITING

Rainbow & Sea Hospital

Saga, Japan

RECRUITING

Saitama Konan Hospital

Saitama, Japan

RECRUITING

Asuka Hospital

Tokyo, Japan

RECRUITING

Nishigahara Hospital

Tokyo, Japan

RECRUITING

Sanyokai Sanyo Hospital

Yamagata, Japan

RECRUITING

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free); clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard); clinical_trial@ono-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (38)