To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
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Change in CMAI score from baseline
Timeframe: up to week 12
Adverse events
Timeframe: up to week 16
Body weight
Timeframe: up to week 16
Body temperature
Timeframe: up to week 16
Blood pressure
Timeframe: up to week 16
Pulse rate
Timeframe: up to week 16
Respiratory rate
Timeframe: up to week 16
ECG RR interval
Timeframe: up to week 12
ECG PR interval
Timeframe: up to week 12
North America Clinical Trial Support Desk
ECG QRS complex
Timeframe: up to week 12
ECG QT interval
Timeframe: up to week 12
ECG QTcF
Timeframe: up to week 12
Number of participants with abnormal laboratory tests (hematology)
Timeframe: up to week 12
Number of participants with abnormal laboratory tests (Clinical chemistry)
Timeframe: up to week 12
Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
Timeframe: up to week 12
Number of participants with abnormal Urinalysis
Timeframe: up to week 12
COLUMBIA-SUICIDE SEVERITY RATING SCALE(C-SSRS)
Timeframe: up to week 16