A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia

Launched by ONO PHARMACEUTICAL CO. LTD · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ONO-2020 to see if it can help reduce agitation in people with Alzheimer's disease dementia. Agitation can include symptoms like restlessness, irritability, or aggressive behavior, and these can be challenging for both patients and their families. The trial is taking place in Japan and is currently looking for participants to join.

To be eligible for the study, participants need to have a confirmed diagnosis of Alzheimer's disease and show signs of agitation for at least two weeks before the trial starts. They should also have a Mini-Mental State Examination score between 5 and 22, which helps measure cognitive function. Participants will need to be hospitalized for the duration of the treatment, which will last for a specific period. Throughout the trial, patients will be monitored closely for the effects of the medication and its safety. If you or a loved one are experiencing agitation due to Alzheimer's, this trial may offer a chance to help manage those symptoms while contributing to important research.

Gender

ALL

Eligibility 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