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ONO-2020-03: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

A phase 2a study of ONO-2020 in patients with agitation associated with Alzheimer's disease dementia

Hirashima Yoshinori

Ono Pharmaceutical Co.,LTD

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

clinical_trial@ono-pharma.com

JP Clinical Trial Support Desk

Ono Pharmaceutical Co.,LTD

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

+81-120-278-120

clinical_trial@ono-pharma.com

Recruiting

Jan. 28, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Patients with agitation associated with AD dementia

The IMP is administered as follows according to the assigned administration group.
- ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
- Placebo group: Two ONO-2020 placebo tablets will be orally administered once daily.

Efficacy assessments:
- Change in CMAI score from baseline to Week 12

Safety assessments
- Adverse events
- Body weight
- Vital signs
- 12-lead electrocardiogram
- Laboratory test
- C-SSRS

Efficacy assessments:
- CMAI score at each visit and change from baseline
- CGI-S score at each visit and change from baseline
- CGI-I score at each visit
- NPI-NH score at each visit and change from baseline
- MMSE score at baseline and Week 12, and change from baseline
- ADCS-ADL score at baseline and Week 12, and change from baseline
- Duration of the investigational medicinal product administration

Pharmacokinetic assessments:
- Plasma ONO-2020 concentrations

+81-3-6804-2227

Dec. 03, 2024

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