RecruitingPhase 2

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

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Asset

ONO-2020

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 5-22

Primary endpoints

•CMAI score•Adverse events•Body weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

RegistryjRCT2041230153Japan Registry of Clinical Trials

NCT IDNCT06803823

Org study IDONO-2020-03

Timeline

Milestones

Study first posted2025-01-31actual

Study start2025-05-01actual

Last update posted2026-05-12actual

Primary completion2026-12-31estimated

Study completion2027-03-31estimated

Assets

Drug assets

ONO-2020

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Behavior / neuropsychiatric

Other clinical outcomes

Global cognition

Function / daily living

Global cognition

1 endpoint

Secondary/protocol endpoint

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

Time frame:up to 12 week

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Change in CMAI score from baseline

Time frame:up to week 12

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:up to 12 week

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:up to 12 week

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Safety / tolerability / PK

13 endpoints

Primary/protocol endpoint

Adverse events

Time frame:up to week 16

event count, event

Primary/protocol endpoint

Body weight

Time frame:up to week 16

descriptive

Primary/protocol endpoint

Body temperature

Time frame:up to week 16

descriptive

Primary/protocol endpoint

Blood pressure

Time frame:up to week 16

descriptive

Primary/protocol endpoint

Pulse rate

Time frame:up to week 16

descriptive

Primary/protocol endpoint

Respiratory rate

Time frame:up to week 16

descriptive

Primary/protocol endpoint

ECG RR interval

Time frame:up to week 12

descriptive

Primary/protocol endpoint

ECG PR interval

Time frame:up to week 12

descriptive

Primary/protocol endpoint

ECG QRS complex

Time frame:up to week 12

descriptive

Primary/protocol endpoint

ECG QT interval

Time frame:up to week 12

descriptive

Primary/protocol endpoint

ECG QTcF

Time frame:up to week 12

descriptive

Primary/protocol endpoint

COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）

Time frame:up to week 16

descriptive

Secondary/protocol endpoint

Pharmacokinetic assessments

Time frame:up to 12 week

concentration, descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

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

Time frame:up to 12 week

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:up to 12 week

descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Number of participants with abnormal laboratory tests (hematology)

Time frame:up to week 12

event count, event

Primary/protocol endpoint/low confidence

Number of participants with abnormal laboratory tests (Clinical chemistry)

Time frame:up to week 12

event count, event

Primary/protocol endpoint/low confidence

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

event count, event

Primary/protocol endpoint/low confidence

Number of participants with abnormal Urinalysis

Time frame:up to week 12

event count, event

Secondary/protocol endpoint/low confidence

Duration of the investigational medicinal product administration

Time frame:up to 12 week

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.