Agitation Associated With Alzheimer's Disease DementiaPhase 2NCT06803823
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
A Phase 2 study testing ONO-2020 in people with Agitation Associated With Alzheimer's Disease Dementia, run by Ono Pharmaceutical Co., Ltd. at 39 sites in Japan.
Trial summary
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Agitation Associated With Alzheimer's Disease Dementia
- What is being tested?
- ONO-2020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 39 sitesJapan
- Study dates
- 1 May 2025to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
39 sites in 1 country
Japan39 sites, 36 recruiting
- Recruiting
Hotei Hospital
Aichi
- Recruiting
Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
Akita
- Recruiting
Medical Corporation Keishinkai Kyowa Hospital
Akita
- Recruiting
Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
Aomori
- Recruiting
Seinan Hospital
Aomori
- Recruiting
Fukui Hospital
Fukui
- Recruiting
Matsubara Hospital
Fukui
- Recruiting
Aburayama Hospital
Fukuoka
- Recruiting
Kuramitsu Hospital
Fukuoka
- Recruiting
Kishikai Kishi Hospital
Gunma
- Recruiting
Hayakawa Clinic
Hiroshima
- Recruiting
Koseikai Cocoro Hospital Kusatsu
Hiroshima
- Recruiting
Nakamura Hospital
Hiroshima
- Recruiting
Keiseikai Hospital
Hokkaido
- Recruiting
NHO Obihiro National Hospital
Hokkaido
- Recruiting
Airanomori Hospital
Kagoshima
- Recruiting
Ishiki Hospital
Kagoshima
- Recruiting
Sansyu Hospital
Kagoshima
- Recruiting
Taniyama Hospital
Kagoshima
- Recruiting
Fujisawahospital
Kanagawa
- Recruiting
Hatano Kousei Hospital
Kanagawa
- Recruiting
Showa Medical University Northern Yokohama Hospital
Kanagawa
- Recruiting
Hosogi Hospital
Kochi
- Terminated
Ichiyo Mental Hospital
Kochi
- Recruiting
Maizuru Medical Center
Kyoto
- Recruiting
Nishiyama Hospital
Kyoto
- Recruiting
Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
Miyagi
- Recruiting
JA-Nagano North Alps Medical Center Azumi Hospital
Nagano
- Recruiting
Jizenkai Ando Hospital
Nagano
- Recruiting
Nara Medical University Hospital
Nara
- Recruiting
Nagaokai Neyagawa Sanatorium
Osaka
- Recruiting
Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
Osaka
- Recruiting
Osaka Psychiatric Medical Center
Osaka
- Recruiting
Hizen Psychiatric Center
Saga
- Recruiting
Rainbow & Sea Hospital
Saga
- Recruiting
Saitama Konan Hospital
Saitama
- Terminated
Asuka Hospital
Tokyo
- Terminated
Nishigahara Hospital
Tokyo
- Recruiting
Sanyokai Sanyo Hospital
Yamagata
About this study
Official title: A Phase 2a, Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
- Being tested
- ONO-2020, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2020Drug
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
PlaceboDrug
Two ONO-2020 placebo tablets will be orally administered once daily
| Study group | Role | What they receive |
|---|---|---|
| ONO-2020 | Experimental | Not described Receives: Drug: ONO-2020 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CMAI score from baseline
To assess agitation symptoms
Measured: up to week 12
Adverse events
To Evaluate the Safety
Measured: up to week 16
Body weight
To Evaluate the Safety
Measured: up to week 16
Body temperature
To Evaluate the Safety
Measured: up to week 16
Blood pressure
To Evaluate the Safety
Measured: up to week 16
Pulse rate
To Evaluate the Safety
Measured: up to week 16
Respiratory rate
To Evaluate the Safety
Measured: up to week 16
ECG RR interval
To Evaluate the Safety
Measured: up to week 12
ECG PR interval
To Evaluate the Safety
Measured: up to week 12
ECG QRS complex
To Evaluate the Safety
Measured: up to week 12
ECG QT interval
To Evaluate the Safety
Measured: up to week 12
ECG QTcF
To Evaluate the Safety
Measured: up to week 12
Number of participants with abnormal laboratory tests (hematology)
Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit)
Measured: 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)
Measured: 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))
Measured: up to week 12
Number of participants with abnormal Urinalysis
Urinalysis (pH, Glucose, Protein, Blood, Ketones)
Measured: up to week 12
COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）
To Evaluate the Safety
Measured: up to week 16
Secondary outcomes (8)
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.
Measured: 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.
Measured: up to 12 week
Clinical Global Impression-Severity （CGI-S） score at each visit
To Evaluate the Efficacy
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 week
Duration of the investigational medicinal product administration
To Evaluate the Efficacy
Measured: up to 12 week
Pharmacokinetic assessments
Plasma ONO-2020 concentrations
Measured: up to 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation Associated With Alzheimer's Disease DementiaStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803823
- Sponsor's protocol ID
- ONO-2020-03
- Other IDs
- jRCT2041230153
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
- ClinicalTrials.gov ID
- NCT06803823
- Acronym / sponsor ID
- ONO-2020-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-2020 | Experimental | Drug: ONO-2020 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-2020ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily. | Drug | ONO-2020 |
| PlaceboTwo ONO-2020 placebo tablets will be orally administered once daily | Drug | Placebo |
Primary outcome
Change in CMAI score from baseline
Time frame: up to week 12
To assess agitation symptoms
Adverse events
Time frame: up to week 16
To Evaluate the Safety
Body weight
Time frame: up to week 16
To Evaluate the Safety
Body temperature
Time frame: up to week 16
To Evaluate the Safety
Blood pressure
Time frame: up to week 16
To Evaluate the Safety
Pulse rate
Time frame: up to week 16
To Evaluate the Safety
Respiratory rate
Time frame: up to week 16
To Evaluate the Safety
ECG RR interval
Time frame: up to week 12
To Evaluate the Safety
ECG PR interval
Time frame: up to week 12
To Evaluate the Safety
ECG QRS complex
Time frame: up to week 12
To Evaluate the Safety
ECG QT interval
Time frame: up to week 12
To Evaluate the Safety
ECG QTcF
Time frame: up to week 12
To Evaluate the Safety
Number of participants with abnormal laboratory tests (hematology)
Time frame: up to week 12
Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit)
Number of participants with abnormal laboratory tests (Clinical chemistry)
Time frame: 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))
Time frame: up to week 12
Blood coagulation (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
Number of participants with abnormal Urinalysis
Time frame: up to week 12
Urinalysis (pH, Glucose, Protein, Blood, Ketones)
COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）
Time frame: up to week 16
To Evaluate the Safety
8 secondary outcomes
Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline
Time frame: up to 12 week
Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline
Time frame: up to 12 week
Clinical Global Impression-Severity （CGI-S） score at each visit
Time frame: up to 12 week
Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline
Time frame: up to 12 week
Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline
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
Time frame: up to 12 week
Duration of the investigational medicinal product administration
Time frame: up to 12 week
Pharmacokinetic assessments
Time frame: up to 12 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono Pharmaceutical Co., Ltd.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-2020 in people with Agitation Associated With Alzheimer's Disease Dementia, run by Ono Pharmaceutical Co., Ltd. at 39 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CMAI score from baseline (time frame: up to week 12). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.