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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: 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

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
GroupInterventionDescription
ONO-2020ONO-2020-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
ECG RR intervalup to week 12

To Evaluate the Safety

ECG PR intervalup to week 12

To Evaluate the Safety

ECG QRS complexup to week 12

To Evaluate the Safety

ECG QT intervalup to week 12

To Evaluate the Safety

ECG QTcFup 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 Urinalysisup 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 baselineup to week 12

To assess agitation symptoms

Adverse eventsup to week 16

To Evaluate the Safety

Body weightup to week 16

To Evaluate the Safety

Body temperatureup to week 16

To Evaluate the Safety

Blood pressureup to week 16

To Evaluate the Safety

Pulse rateup to week 16

To Evaluate the Safety

Respiratory rateup to week 16

To Evaluate the Safety

Secondary Outcome Measures
NameTimeMethod
Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baselineup 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 baselineup 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 visitup to 12 week

To Evaluate the Efficacy

Neuropsychiatric Inventory in Nursing Home Version(NPI-NH) score at each visit and change from baselineup 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 baselineup 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 baselineup 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 administrationup to 12 week

To Evaluate the Efficacy

Pharmacokinetic assessmentsup 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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Hotei Hospital
🇯🇵Aichi, Japan

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