A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
- 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
- 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
- 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
Related Research Topics
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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
Scroll for more (15 remaining)Hotei Hospital🇯🇵Aichi, Japan