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).
| 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) |
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:
Agitation significantly impacts:
Current pharmacological options for agitation in AD are limited and often have significant drawbacks:
This creates an unmet medical need for safe, effective treatments for AD-related agitation.
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) for mild to moderate Alzheimer's disease cognitive symptoms.
The epigenetic mechanism may address agitation through:
| Arm | Description |
|---|---|
| ONO-2020 | Two ONO-2020 tablets orally once daily |
| Placebo | Two matching placebo tablets orally once daily |
The trial is conducted at multiple sites across Japan:
| 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 |
This trial relates to several key NeuroWiki topics:
This trial is currently RECRUITING participants in Japan.
For the most current information on enrollment status and eligibility: