A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 22
- 主要终点
- Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging
研究概览
简要总结
AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, the Src family kinases (SFKs) are highly expressed in brain and have major effects on synaptic plasticity2. Moreover, the investigators have recently shown that a specific SFK, namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß) peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in preclinical models. This clinical trial will test the potential benefit of AZD0530 for Alzheimer's disease modification.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AZD0530 100mg daily
Patients in the experimental group (50%) will be started on this dose. After 2 weeks, patients with a plasma drug level of <100ng/ml will receive 125mg AZD0530 daily and remain in the same experimental group as patient receiving 100mg daily.
干预措施: AZD0530 100mg daily (Drug)
AZD0530 100mg daily
Patients in the experimental group (50%) will be started on this dose. After 2 weeks, patients with a plasma drug level of <100ng/ml will receive 125mg AZD0530 daily and remain in the same experimental group as patient receiving 100mg daily.
干预措施: AZD0530 125mg daily (Drug)
AZD0530 Placebo
50% of patients will receive placebo treatment for the duration of the study,
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging
时间窗: 12 months
Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.
Number of Participants With One or More Serious/Other Adverse Events Subjects With Mild AD as Assessed by Analysis of Adverse Events, Including Symptoms, and Abnormal Findings on Physical and Neurological Examinations, and Standard Labs.
时间窗: 12 months
Assessment of any adverse effects between drug and placebo-treated subjects
次要结局
- Percent Change in Brain Volume Before and After Treatment(12 months)
- The Effect of Treatment With AZD0530 on Cognitive and Behavioral Function(12 months)
- Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging(12 months)
- Cerebrospinal Fluid Levels of Total Tau, Phospho-tau (p-Tau), and Amyloid-beta 1-42 (Abeta 1-42)(12 months)
研究者
Stephen M. Strittmatter
Professor of Neurology and Neurobiology
Yale University