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

Официальное название

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

Обзор

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

Вмешательства

• Препарат ONO-2020
  ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
• Препарат Placebo
  Two ONO-2020 placebo tablets will be orally administered once daily

Первичные конечные точки

• Change in CMAI score from baseline [Срок оценки: up to week 12]
• Adverse events [Срок оценки: up to week 16]
• Body weight [Срок оценки: up to week 16]
• Body temperature [Срок оценки: up to week 16]
• Blood pressure [Срок оценки: up to week 16]
• Pulse rate [Срок оценки: up to week 16]
• Respiratory rate [Срок оценки: up to week 16]
• ECG RR interval [Срок оценки: up to week 12]
• ECG PR interval [Срок оценки: up to week 12]
• ECG QRS complex [Срок оценки: up to week 12]

Вторичные конечные точки (8)

• Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline [Срок оценки: up to 12 week]
• Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline [Срок оценки: up to 12 week]
• Clinical Global Impression-Severity （CGI-S） score at each visit [Срок оценки: up to 12 week]
• Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline [Срок оценки: up to 12 week]
• Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline [Срок оценки: up to 12 week]
• Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)score at baseline and Week 12, and change from baseline [Срок оценки: up to 12 week]
• Duration of the investigational medicinal product administration [Срок оценки: up to 12 week]
• Pharmacokinetic assessments [Срок оценки: up to 12 week]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Япония · 38 центров

• Hotei Hospital — Aichi
• Akita Prefectural Center For Rehabilitation and Psychiatric Medicine — Akita
• Medical Corporation Keishinkai Kyowa Hospital — Akita
• Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital — Aomori
• Seinan Hospital — Aomori
• Fukui Hospital — Fukui
• Matsubara Hospital — Fukui
• Aburayama Hospital — Fukuoka
• … и ещё 30 центров

Идентификаторы

NCT: NCT06803823 · ONO-2020-03 · jRCT2041230153

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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