Evaluating ONO-2020 for agitation in Alzheimer's patients
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
This study is testing if a new medication called ONO-2020 can help reduce agitation in people with Alzheimer's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 38 sites (Aichi and 37 other locations) |
| Trial ID | NCT06803823 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of ONO-2020 in patients experiencing agitation associated with Alzheimer's Disease dementia. The study will involve administering ONO-2020 or a placebo to eligible participants, who must have a confirmed diagnosis of Alzheimer's and meet specific criteria related to their cognitive function and agitation symptoms. The trial will take place in Japan, focusing on hospitalized patients to ensure close monitoring throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with probable Alzheimer's Disease dementia who exhibit symptoms of agitation and meet specific cognitive assessment criteria.
Not a fit: Patients with forms of dementia other than Alzheimer's or those with severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce agitation in Alzheimer's patients, improving their quality of life.
How similar studies have performed: While there have been studies on agitation in Alzheimer's patients, the specific use of ONO-2020 represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Aichi and 37 other locations
- Hotei Hospital — Aichi, Japan (Recruiting)
- Akita Prefectural Center For Rehabilitation and Psychiatric Medicine — Akita, Japan (Recruiting)
- Medical Corporation Keishinkai Kyowa Hospital — Akita, Japan (Recruiting)
- Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital — Aomori, Japan (Recruiting)
- Seinan Hospital — Aomori, Japan (Recruiting)
- Fukui Hospital — Fukui, Japan (Recruiting)
- Matsubara Hospital — Fukui, Japan (Recruiting)
- Aburayama Hospital — Fukuoka, Japan (Recruiting)
- Kuramitsu Hospital — Fukuoka, Japan (Recruiting)
- Kishikai Kishi Hospital — Gunma, Japan (Recruiting)
- Hayakawa Clinic — Hiroshima, Japan (Recruiting)
- Koseikai Cocoro Hospital Kusatsu — Hiroshima, Japan (Recruiting)
- Nakamura Hospital — Hiroshima, Japan (Recruiting)
- Keiseikai Hospital — Hokkaido, Japan (Recruiting)
- NHO Obihiro National Hospital — Hokkaido, Japan (Recruiting)
- Airanomori Hospital — Kagoshima, Japan (Recruiting)
- Ishiki Hospital — Kagoshima, Japan (Recruiting)
- Sansyu Hospital — Kagoshima, Japan (Recruiting)
- Taniyama Hospital — Kagoshima, Japan (Recruiting)
- Fujisawahospital — Kanagawa, Japan (Recruiting)
- Hatano Kousei Hospital — Kanagawa, Japan (Recruiting)
- Showa Medical University Northern Yokohama Hospital — Kanagawa, Japan (Recruiting)
- Hosogi Hospital — Kochi, Japan (Recruiting)
- Ichiyo Mental Hospital — Kochi, Japan (Recruiting)
- Maizuru Medical Center — Kyoto, Japan (Recruiting)
- Nishiyama Hospital — Kyoto, Japan (Recruiting)
- Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba — Miyagi, Japan (Recruiting)
- JA-Nagano North Alps Medical Center Azumi Hospital — Nagano, Japan (Recruiting)
- Jizenkai Ando Hospital — Nagano, Japan (Recruiting)
- Nara Medical University Hospital — Nara, Japan (Recruiting)
- Nagaokai Neyagawa Sanatorium — Osaka, Japan (Recruiting)
- Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital — Osaka, Japan (Recruiting)
- Hizen Psychiatric Center — Saga, Japan (Recruiting)
- Rainbow & Sea Hospital — Saga, Japan (Recruiting)
- Saitama Konan Hospital — Saitama, Japan (Recruiting)
- Asuka Hospital — Tokyo, Japan (Recruiting)
- Nishigahara Hospital — Tokyo, Japan (Recruiting)
- Sanyokai Sanyo Hospital — Yamagata, Japan (Recruiting)
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.