NCT07781657尚未招募2 期
A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early Symptomatic Alzheimer's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 450
- 主要终点
- Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
研究概览
简要总结
This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF)
- •Mild cognitive impairment (MCI) or mild dementia due to AD
- •Able to swallow whole capsules
- •Body mass index (BMI) within the range of 18-34 kilograms per square metre (kg/m²) (at screening)
- •Availability of an appropriate study partner
排除标准
- •Any evidence of a condition other than AD that may affect cognition
- •Participants must not have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities
- •History or presence of clinically significant cerebrovascular disease
- •Clinically significant cerebral abnormalities on magnetic resonance imaging (MRI)
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
时间窗: From baseline up to Week 72
次要结局
- Plasma Concentrations of RO7568282 and its Metabolite[s](Up to approximately Week 76)
- Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)(From baseline up to Week 72)
- Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score(From baseline up to Week 72)
- Incidence of Adverse Events (AEs)(Up to approximately Week 76)
- Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)(From baseline up to Week 76)
研究者
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