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

Last updated: March 24, 2025
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Williams Syndrome

Manic Disorders

Treatment

ONO-2020

Placebo

Clinical Study ID

NCT06803823
ONO-2020-03
  • Ages 55-90
  • All Genders

Study Summary

To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.

Eligibility Criteria

Inclusion

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 treatmentperiod

  • Symptoms of agitation defined by the IPA from at least 14 days before the start ofthe 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 beforethe start of the treatment period to throughout the treatment period

Exclusion

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 associatedwith Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementiaassociated with human immunodeficiency virus (HIV) infection, traumatic braininjury, normal pressure hydrocephalus, or other non-AD dementia

  • Any MRI or CT scan of the brain performed after the onset of dementia with findingsconsistent with clinically relevant CNS disease other than AD, such as vascularchanges (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 ofdelirium

  • 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) orany suicide attempt within 6 months before the start of the screening period, or atserious risk of suicide in the opinion of the investigator or subinvestigator

  • Prior or current treatment with anti-amyloid beta antibodies

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: ONO-2020
Phase: 2
Study Start date:
February 01, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Hatano Kousei Hospital

    Kanagawa,
    Japan

    Active - Recruiting

  • Rainbow & Sea Hospital

    Saga,
    Japan

    Site Not Available

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