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

Phase 2

Recruiting

• Conditions: Agitation Associated With Alzheimer's Disease Dementia
• Interventions: Drug: ONO-2020; Drug: Placebo

• Registration Number: NCT06803823
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-31
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-2020	ONO-2020	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
ECG RR interval	up to week 12	To Evaluate the Safety
ECG PR interval	up to week 12	To Evaluate the Safety
ECG QRS complex	up to week 12	To Evaluate the Safety
ECG QT interval	up to week 12	To Evaluate the Safety
ECG QTcF	up to week 12	To Evaluate the Safety
Number of participants with abnormal laboratory tests (hematology)	up to week 12	Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit)
Number of participants with abnormal laboratory tests (Clinical chemistry)	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)
Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))	up to week 12	Blood coagulation (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
Number of participants with abnormal Urinalysis	up to week 12	Urinalysis (pH, Glucose, Protein, Blood, Ketones)
COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）	up to week 16	To Evaluate the Safety
Change in CMAI score from baseline	up to week 12	To assess agitation symptoms
Adverse events	up to week 16	To Evaluate the Safety
Body weight	up to week 16	To Evaluate the Safety
Body temperature	up to week 16	To Evaluate the Safety
Blood pressure	up to week 16	To Evaluate the Safety
Pulse rate	up to week 16	To Evaluate the Safety
Respiratory rate	up to week 16	To Evaluate the Safety

Secondary Outcome Measures

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

Trial Locations

Locations (25)

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

Matsubara Hospital; 🇯🇵 Fukui, Japan

Aburayama Hospital; 🇯🇵 Fukuoka, Japan

Kuramitsu Hospital; 🇯🇵 Fukuoka, Japan

Kishikai Kishi Hospital; 🇯🇵 Gunma, Japan

Hayakawa Clinic; 🇯🇵 Hiroshima, Japan

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