NCT04191486已完成2 期
A Phase 2 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 37
- 主要终点
- The change in the CSF p-tau181 from Baseline to Week 78
研究概览
简要总结
Primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein phosphorylated at threonine 181 (p-tau 181) in cerebrospinal fluid (CSF) compared with placebo in patients with a diagnosis of MCI due to AD or mild AD.
Secondary objectives are:
- To evaluate in patients on T-817MA and placebo:
- cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and working memory and attention domain as measured by the Cognitive Functional Composite (CFC).
- AD-related biomarkers in CSF and plasma
- imaging analysis using volumetric magnetic resonance imaging (vMRI)
- alpha/theta ratio of the electroencephalogram (EEG)
- To evaluate the safety of T-817MA by clinical laboratory tests and adverse events (AEs).
- To evaluate the pharmacokinetics of T-817MA
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female of non-childbearing potential or male, ages 50 to 80 years (inclusive)
- •MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive)
- •CSF results at Screening consistent with the presence of Aß and p-tau181 abnormality (≤1000 pg/ml for Aß, ≥19 pg/ml for p-tau181).
- •Taking stable dose of AChE Inhibitor (donepezil, galantamine or rivastigmine) at least for 3 months prior to randomization, or not taking any AChE Inhibitors.
排除标准
- •MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD
- •Taking memantine
- •Any contraindications to lumbar puncture
- •Any contraindications to MRI
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
T-817MA (448 mg)
Experimental
干预措施: T-817MA (Drug)
结局指标
主要结局
The change in the CSF p-tau181 from Baseline to Week 78
时间窗: Baseline to Week 78
次要结局
- The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the CSF p-tau217 from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the CSF total tau from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the CSF neurogranin from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in cognitive function assessed by CDR-sb and working memory and attention domain as measured by the CFC from Baseline to Weeks 28, 52 and 78(Baseline to Weeks 28, 52 and 78)
- The change in the CSF p-tau181 from Baseline to Week 52(Baseline to Week 52)
- The change in the CSF YKL-40 from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the plasma NFL from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in the CSF Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78(Baseline to Weeks 52 and 78)
- Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax)(Weeks 16, 28, 40, and 65)
- Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h)(Weeks 16, 28, 40, and 65)
- Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs(Screening to Week 82)
- Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin)(Weeks 16, 28, 40, and 65)
研究者
研究点 (37)
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