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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 69
- 主要终点
- Change in CMAI score from baseline
研究概览
简要总结
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
ONO-2020
干预措施: ONO-2020 (Drug)
结局指标
主要结局
Change in CMAI score from baseline
时间窗: up to week 12
To assess agitation symptoms
Adverse events
时间窗: up to week 16
To Evaluate the Safety
Body weight
时间窗: up to week 16
To Evaluate the Safety
Body temperature
时间窗: up to week 16
To Evaluate the Safety
Blood pressure
时间窗: up to week 16
To Evaluate the Safety
Pulse rate
时间窗: up to week 16
To Evaluate the Safety
Respiratory rate
时间窗: up to week 16
To Evaluate the Safety
ECG RR interval
时间窗: up to week 12
To Evaluate the Safety
ECG PR interval
时间窗: up to week 12
To Evaluate the Safety
ECG QRS complex
时间窗: up to week 12
To Evaluate the Safety
ECG QT interval
时间窗: up to week 12
To Evaluate the Safety
ECG QTcF
时间窗: up to week 12
To Evaluate the Safety
Number of participants with abnormal laboratory tests (hematology)
时间窗: up to week 12
Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit)
Number of participants with abnormal laboratory tests (Clinical chemistry)
时间窗: up to week 12
Clinical chemistry (Blood urea nitrogen (BUN), Potassium, Creatinine, Sodium, Glucose (fasting or nonfasting), Calcium, Chloride, Total protein, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase, Total and direct bilirubin, Lactate dehydrogenase (LDH), Phospholipid, γ-Glutamyl transferase (GGT)
Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
时间窗: up to week 12
Blood coagulation (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
Number of participants with abnormal Urinalysis
时间窗: up to week 12
Urinalysis (pH, Glucose, Protein, Blood, Ketones)
COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）
时间窗: up to week 16
To Evaluate the Safety
次要结局
- Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline(up to 12 week)
- Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline(up to 12 week)
- Clinical Global Impression-Severity （CGI-S） score at each visit(up to 12 week)
- Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline(up to 12 week)
- Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline(up to 12 week)
- Duration of the investigational medicinal product administration(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(up to 12 week)
- Pharmacokinetic assessments(up to 12 week)