A Randomized, Placebo-controlled, Parallel Group, 72-week Study to Evaluate the Efficacy and Safety of VHB937 in Participants With Early Alzheimer's Disease Followed by an Extension
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 407
- 试验地点
- 72
- 主要终点
- Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
研究概览
简要总结
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early AD followed by an Extension. The double-blind part is 72 weeks long, followed by an extension.
详细描述
The purpose of this study is to find out whether treatment with VHB937 is safe and beneficial in people with early Alzheimer's disease. The study will evaluate the safety of VHB937, as well as its effects on memory and other thinking abilities, on daily activities, and on changes in the brain. The study will also observe and measure how VHB937 is processed by the body and how the body responds to it.
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, Investigator, Outcomes Assessor)
盲法说明
Blinded placebo for infusion
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants 50 to 85 years of age
- •Diagnosis of Mild Cognitive Impairment (MCI) due to AD or mild AD
- •Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0
- •Confirmation of AD based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging
- •Reliable study partner who can accompany the participant at study visits
- •If on symptomatic AD treatment (AChEIs/memantine), on a stable dose prior to starting study treatment
排除标准
- •Dementia due to a condition other than AD, including but not limited to, frontal temporal dementia, Parkinson's disease, dementia with Lewy bodies, Huntington disease, vascular dementia.
- •History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study
- •Transient ischemic attacks (TIA) or stroke occurring within 12 months
- •Clinical evidence of liver or renal disease/injury
- •Current major depressive episode that is not adequately controlled, history of schizophrenia, other chronic psychosis
- •Significant neurological disease other than dementia (e.g. serious brain infection, traumatic brain injury, multiple concussions, epilepsy or recurrent seizures
- •Presence of suicidal ideation within 6 months or suicidal behavior within 2 years before Screening
- •Presence of cancer, HIV, Hep B, Hep C, uncontrolled thyroid disease, uncontrolled diabetes
- •Taking any prohibited medications
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
I.V. infusions
干预措施: Placebo (Other)
VHB937 Low Dose
I.V. infusions
干预措施: VHB937 (Biological)
VHB937 High Dose
I.V. infusions
干预措施: VHB937 (Biological)
结局指标
主要结局
Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
时间窗: Baseline and Week 72
The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. Based on in-depth semi-structured interview, each domain is assigned a score, which is summed to obtain the Sum of Boxes (SB) score, ranging from 0 to 18 with higher scores indicating worse condition
次要结局
- Change from Baseline in instrumental activities of daily living (iADL) on the Alzheimers Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale(Baseline over time until Week 72)
- Pharmacokinetic parameters of VHB937 in serum - Cmax(Baseline over time until Week 72)
- Pharmacokinetic parameters of VHB937 in serum - Ctrough(Baseline over time until Week 72)
- VHB937 immunogenicity in serum(Baseline over time until Week 72)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From First treatment to end of study (up to 63 months approximately))
- Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14)(Baseline over time until Week 72)
- Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)(Baseline over time until Week 72)
- Pharmacokinetic parameters of VHB937 in serum - Tmax(Baseline over time until Week 72)