To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Change in CMAI score from baseline
To assess agitation symptoms
Time frame: up to week 12
Adverse events
To Evaluate the Safety
Time frame: up to week 16
Body weight
To Evaluate the Safety
Time frame: up to week 16
Body temperature
To Evaluate the Safety
Time frame: up to week 16
Blood pressure
To Evaluate the Safety
Time frame: up to week 16
Pulse rate
To Evaluate the Safety
Time frame: up to week 16
Respiratory rate
To Evaluate the Safety
Time frame: up to week 16
ECG RR interval
To Evaluate the Safety
Time frame: up to week 12
ECG PR interval
To Evaluate the Safety
Time frame: up to week 12
ECG QRS complex
To Evaluate the Safety
Time frame: up to week 12
ECG QT interval
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Hotei Hospital
Aichi, Japan
RECRUITINGAkita Prefectural Center For Rehabilitation and Psychiatric Medicine
Akita, Japan
RECRUITINGMedical Corporation Keishinkai Kyowa Hospital
Akita, Japan
RECRUITINGAiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
Aomori, Japan
RECRUITINGSeinan Hospital
Aomori, Japan
RECRUITINGFukui Hospital
Fukui, Japan
RECRUITINGMatsubara Hospital
Fukui, Japan
RECRUITINGAburayama Hospital
Fukuoka, Japan
RECRUITINGKuramitsu Hospital
Fukuoka, Japan
RECRUITINGKishikai Kishi Hospital
Gunma, Japan
RECRUITING...and 28 more locations
To Evaluate the Safety
Time frame: up to week 12
ECG QTcF
To Evaluate the Safety
Time frame: up to week 12
Number of participants with abnormal laboratory tests (hematology)
Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit)
Time frame: 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)
Time frame: 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))
Time frame: up to week 12
Number of participants with abnormal Urinalysis
Urinalysis (pH, Glucose, Protein, Blood, Ketones)
Time frame: up to week 12
COLUMBIA-SUICIDE SEVERITY RATING SCALE(C-SSRS)
To Evaluate the Safety
Time frame: up to week 16
Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline
To Evaluate the Efficacy The range of CMAI score is 29-203. Higher score means a worse outcome.
Time frame: up to 12 week
Clinical Global Impression-Severity (CGI-S) score at each visit and change from baseline
To Evaluate the Efficacy The range of CGI-S score is 0-7. Higher score means a worse outcome.
Time frame: up to 12 week
Clinical Global Impression-Severity (CGI-S) score at each visit
To Evaluate the Efficacy
Time frame: up to 12 week
Neuropsychiatric Inventory in Nursing Home Version(NPI-NH) score at each visit and change from baseline
To Evaluate the Efficacy The range of NPI-NH score is 0-170. Higher score means a worse outcome.
Time frame: up to 12 week
Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline
To Evaluate the Efficacy The range of MMSE score is 0-30. Higher score means a better outcome.
Time frame: up to 12 week
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)score at baseline and Week 12, and change from baseline
To Evaluate the Efficacy The range of ADCS-ADL score is 0-78. Higher score means a better outcome.
Time frame: up to 12 week
Duration of the investigational medicinal product administration
To Evaluate the Efficacy
Time frame: up to 12 week
Pharmacokinetic assessments
Plasma ONO-2020 concentrations
Time frame: up to 12 week