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

RecruitingPhase 2Ages 55 Years - 90 YearsAllOno Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011) * Mini-Mental State Examination (MMSE) score โ‰ฅ 5 to โ‰ค 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 โ‰ฅ 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
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What it tests

  • ONO-2020
  • Placebo
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Where

39 sites
Hotei Hospital
Aichi, Japan
Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
Akita, Japan
Medical Corporation Keishinkai Kyowa Hospital
Akita, Japan
Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
Aomori, Japan
Seinan Hospital
Aomori, Japan
Fukui Hospital
Fukui, Japan
Matsubara Hospital
Fukui, Japan
Aburayama Hospital
Fukuoka, Japan

โ€ฆand 31 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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