NCT06803823 - ONO-2020 for Agitation in Alzheimer's Disease

NCT06803823: ONO-2020 for Agitation in Alzheimer's Disease

Overview

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

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

• 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

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

Secondary Outcomes

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Age 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)

Contact Information

• North America: clinical_trial@ono-pharma.com | +1-866-587-7745
• International: clinical_trial@ono-pharma.com | +1-716-214-1777