Evaluating ONO-2020 for agitation in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: North America Clinical Trial Support Desk
• Email: clinical_trial@ono-pharma.com
• Phone: +18665877745(Toll-Free)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• DCC-2618 in GIST after at least 3 prior treatments

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.