A Phase 2 interventional study of ONO-2020 and Placebo in Agitation Associated With Alzheimer's Disease Dementia, sponsored by Ono Pharmaceutical Co., Ltd.. Recruiting at 39 sites in Japan. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ONO-2020
Drug: Placebo
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
Two ONO-2020 placebo tablets will be orally administered once daily
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
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
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Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 19 months is below that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: ONO-2020
Ono Pharmaceutical Co., Ltd. →