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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 25, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06803823). This is a study registration, not published results. Lead sponsor: Ono Pharmaceutical Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Agitation Associated With Alzheimer's Disease Dementia. Interventions: DRUG: ONO-2020; DRUG: Placebo. Primary outcome measures: Change in CMAI score from baseline , up to week 12; Adverse events , up to week 16; Body weight , up to week 16; Body temperature , up to week 16; Blood pressure , up to week 16; Pulse rate , up to week 16; Respiratory rate , up to week 16; ECG RR interval , up to week 12; ECG PR interval , up to week 12; ECG QRS complex , up to week 12; ECG QT interval , up to week 12; ECG QTcF , up to week 12; Number of participants with abnormal laboratory tests (hematology) , up to week 12; Number of participants with abnormal laboratory tests (Clinical chemistry) , up to week 12; Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR)) , up to week 12; Number of participants with abnormal Urinalysis , up to week 12; COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS） , up to week 16. Brief summary: To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.