NCT06803823: ONO-2020 for Agitation in Alzheimer's Disease
Overview
flowchart TD
clinical_trials_ono_2020_agita["NCT06803823 - ONO-2020 for Agitation in Alzheime"]
clinical_trials_ono_2020_agita["ONO-2020"]
clinical_trials_ono_2020_agita -->|"related to"| clinical_trials_ono_2020_agita
style clinical_trials_ono_2020_agita fill:#81c784,stroke:#333,color:#000
clinical_trials_ono_2020_agita["Alzheimer"]
clinical_trials_ono_2020_agita -->|"related to"| clinical_trials_ono_2020_agita
style clinical_trials_ono_2020_agita fill:#81c784,stroke:#333,color:#000
clinical_trials_ono_2020_agita["Phase"]
clinical_trials_ono_2020_agita -->|"related to"| clinical_trials_ono_2020_agita
style clinical_trials_ono_2020_agita fill:#81c784,stroke:#333,color:#000
clinical_trials_ono_2020_agita["trial"]
clinical_trials_ono_2020_agita -->|"related to"| clinical_trials_ono_2020_agita
style clinical_trials_ono_2020_agita fill:#81c784,stroke:#333,color:#000
style clinical_trials_ono_2020_agita fill:#4fc3f7,stroke:#333,color:#000
NCT06803823 is a Phase 2 clinical trial conducted by Ono Pharmaceutical Co. Ltd. evaluating ONO-2020 for the treatment of agitation associated with Alzheimer's Disease dementia. This trial is conducted exclusively in Japan and represents a novel approach to addressing behavioral and psychological symptoms of dementia (BPSD).
Trial Details
...NCT06803823: ONO-2020 for Agitation in Alzheimer's Disease
Overview
Mermaid diagram (expand to render)
NCT06803823 is a Phase 2 clinical trial conducted by Ono Pharmaceutical Co. Ltd. evaluating ONO-2020 for the treatment of agitation associated with Alzheimer's Disease dementia. This trial is conducted exclusively in Japan and represents a novel approach to addressing behavioral and psychological symptoms of dementia (BPSD).
Trial Details
| Field | Value |
|-------|-------|
| NCT Number | NCT06803823 |
| 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 |
| Phase | Phase 2 |
| Status | RECRUITING |
| Study Type | Interventional |
| Design | Randomized, double-blind, placebo-controlled, parallel assignment |
| Enrollment | 90 participants (estimated) |
| Sponsor | Ono Pharmaceutical Co. Ltd. |
| Start Date | May 2025 (actual) |
| Primary Completion | December 2026 (estimated) |
| Study Completion | March 2027 (estimated) |
| Registry | jRCT2041230152 (Japan) |
Scientific Rationale
Agitation in Alzheimer's Disease
Agitation is one of the most common and challenging behavioral and psychological symptoms of dementia (BPSD), affecting up to 70% of Alzheimer's disease patients during the disease course. Agitation encompasses:
- Physical aggression: Hitting, kicking, pushing, biting
- Verbal aggression: Screaming, shouting, threatening
- Non-aggressive behavior: Pacing, restlessness, repetitive questions
Agitation significantly impacts:
- Patient quality of life and functional abilities
- Caregiver burden and stress
- Healthcare costs and resource utilization
- Long-term care placement decisions
Current Treatment Landscape
Current pharmacological options for agitation in AD are limited and often have significant drawbacks:
- Antipsychotics: Black box warnings for mortality risk in dementia patients
- Benzodiazepines: Risk of sedation, falls, and cognitive worsening
- Antidepressants: Variable efficacy, particularly in SSRIs
This creates an unmet medical need for safe, effective treatments for AD-related agitation.
ONO-2020 Mechanism
While the precise mechanism of ONO-2020 for agitation is not fully disclosed, Ono Pharmaceutical has developed ONO-2020 as an epigenetic regulator. The same compound is being studied in a separate trial ([NCT06881836](/clinical-trials/ono-2020-ad-nct06881836)) for mild to moderate Alzheimer's disease cognitive symptoms.
The epigenetic mechanism may address agitation through:
- Modulation of stress-related gene expression
- Regulation of neurotransmitter systems involved in behavior
- Anti-inflammatory effects in brain regions controlling behavior
Study Design
Treatment Arms
| Arm | Description |
|-----|-------------|
| ONO-2020 | Two ONO-2020 tablets orally once daily |
| Placebo | Two matching placebo tablets orally once daily |
Treatment Duration
- Treatment Period: 12 weeks (up to week 12)
- Safety Follow-up: Additional 4 weeks (up to week 16)
- Total Participant Duration: Approximately 16 weeks
Randomization
- Randomized, double-blind, placebo-controlled
- Quadruple masking (participant, care provider, investigator, outcomes assessor)
Outcomes
Primary Outcomes
Change in Cohen-Mansfield Agitation Inventory (CMAI) score from baseline — Assesses agitation symptoms over 12 weeks
Adverse events — Safety evaluation up to week 16
Vital signs — Blood pressure, pulse rate, respiratory rate, body temperature, body weight
ECG parameters — RR, PR, QRS, QT, QTcF intervals up to week 12
Laboratory tests — Hematology, clinical chemistry, urinalysis up to week 12
Columbia-Suicide Severity Rating Scale (C-SSRS) — Safety evaluation up to week 16Secondary Outcomes
CMAI score at each visit — Evaluate efficacy at multiple timepoints
Clinical Global Impression-Severity (CGI-S) score — Assess overall severity
Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) score — Evaluate neuropsychiatric symptoms
Mini-Mental State Exam (MMSE) score — Cognitive function at baseline and week 12
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score — Functional status at baseline and week 12
Pharmacokinetic assessments — Plasma ONO-2020 concentrationsEligibility Criteria
Inclusion Criteria
Diagnosis of probable AD according to NIA-AA 2011 criteria for AD dementia
MMSE score ≥ 5 to ≤ 22 at start of treatment period
Symptoms of agitation defined by the IPA (International Psychogeriatric Association) from at least 14 days before screening
NPI-NH Agitation/Aggression domain score ≥ 4 at start of treatment period
Able to participate under hospitalization from 21 days before treatment through entire treatment periodExclusion Criteria
Dementia not due to AD (mixed dementia, vascular dementia, DLB, PDD, FTD, etc.)
MRI/CT findings consistent with clinically relevant CNS disease other than AD
Delirium within 30 days before screening or history of delirium
Suicidal ideation (C-SSRS Q4/Q5) or suicide attempt within 6 months
Prior or current treatment with anti-amyloid beta antibodiesAge Range
- Minimum: 55 years
- Maximum: 90 years
Trial Locations
The trial is conducted at multiple sites across Japan:
Active Recruiting Sites
| Prefecture | Facilities |
|------------|------------|
| Aichi | Hotei Hospital |
| Akita | Akita Prefectural Center For Rehabilitation and Psychiatric Medicine, Medical Corporation Keishinkai Kyowa Hospital |
| Aomori | Aiseikai General Incorporated Foundation Hirosaki Aiseikai Hospital, Seinan Hospital |
| Fukui | Fukui Hospital, Matsubara Hospital |
| Fukuoka | Aburayama Hospital, Kuramitsu Hospital |
| Gunma | Kishikai Kishi Hospital |
| Hiroshima | Hayakawa Clinic, Koseikai Cocoro Hospital Kusatsu, Nakamura Hospital |
| Hokkaido | Keiseikai Hospital, NHO Obihiro National Hospital |
| Kagoshima | Ishiki Hospital |
| Kanagawa | Fujisawahospital, Hatano Kousei Hospital, Showa Medical University Northern Yokohama Hospital |
| Kochi | Hosogi Hospital, Ichiyo Mental Hospital |
| Kyoto | Maizuru Medical Center |
| Miyagi | Iryohojin Shadan Shoshinkai Morinohosupitaru Aoba |
| Nagano | JA-Nagano North Alps Medical Center Azumi Hospital, Jizenkai Ando Hospital |
| Osaka | Nagaokai Neyagawa Sanatorium, Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital |
| Saga | Hizen Psychiatric Center, Rainbow & Sea Hospital |
| Saitama | Saitama Konan Hospital |
| Tokyo | Asuka Hospital, Nishigahara Hospital |
| Yamagata | Sanyokai Sanyo Hospital |
Connection to NeuroWiki
This trial relates to several key NeuroWiki topics:
- [ONO-2020 for AD (NCT06881836)](/clinical-trials/ono-2020-ad-nct06881836) — Related Phase 2 trial for cognitive symptoms in mild to moderate AD
- [Agitation in Alzheimer's Disease](/mechanisms/agitation-alzheimers) — The symptom being treated
- [Behavioral and Psychological Symptoms of Dementia (BPSD](/mechanisms/bpsd-alzheimers)) — Symptom category
- [Ono Pharmaceutical](/companies/ono-pharmaceutical) — Pharmaceutical company developing ONO-2020
- [Epigenetic Regulation](/mechanisms/epigenetic-regulation) — Proposed mechanism of ONO-2020
- [Alzheimer's Disease](/diseases/alzheimers-disease) — The disease being studied
Current Status
This trial is currently RECRUITING participants in Japan.
For the most current information on enrollment status and eligibility:
- [ClinicalTrials.gov: NCT06803823](https://clinicaltrials.gov/study/NCT06803823)
- [Japan Registry of Clinical Trials: jRCT2041230152](https://jrct.niph.go.jp)
- North America: clinical_trial@ono-pharma.com | +1-866-587-7745
- International: clinical_trial@ono-pharma.com | +1-716-214-1777