A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients With Early Alzheimer's Disease (Hetero/Homozygote APOE4 Carriers)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)
研究概览
简要总结
A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
详细描述
This study will be a proof of concept, Phase 2a study in patients with early Alzheimer's disease (clinical diagnosis of Alzheimer's disease Stage 3 or 4 based on the National Institute on Aging Alzheimer's Association Research Framework criteria) to evaluate the Pharmacodynamic, cognitive effects, Pharmacokinetic, and safety and tolerability of obicetrapib therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men & women 50-75 years
- •post-menopausal or women not of child-bearing potential
- •diagnosis of Alzheimer's disease based on National Institute for Aging:
- •Biomarker classification A+T+N+ or A+T+N-
- •Clinical Stage 3 or 4 with Clinical Dementia Rating score >/= 0.5 & </= 1; mini-mental state examination (MMSE) score >/=20
- •Have an APOE genotype of E4/E4 or E3/E4
- •not on or on stabilized AD medication
- •Patient & study partner willing to sign consent
排除标准
- •Other than AD, disorder that may impair cognition
- •Contra-indication for MRI
- •History of neurological, psychiatric or mental conditions;
- •history stroke
- •Type 1 diabetes & Type 2 with HbA1c>8%
- •BP > 150/90 mmHg
- •renal or hepatic impaired
- •hyperaldosteronism
- •depression
- •laboratory abnormalities
- •not able to undergo lumbar puncture
- •taking certain medications including lipid altering
研究组 & 干预措施
10mg obicetrapib tablets
10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks
干预措施: Obicetrapib (Drug)
结局指标
主要结局
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)
时间窗: 24 weeks
Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline
时间窗: baseline
Small high-density lipoprotein (s-HDL) particle concentration in cerebrospinal fluid (CSF) measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma
时间窗: 24 weeks
Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)
Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)
时间窗: 24 weeks
Mean percent change from screening (V1) to end of treatment (V6) in ApoE
Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma
时间窗: 24 weeks
Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24
时间窗: Week 24
Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Small HDL (s-HDL) Particle Concentration in Plasma at Baseline
时间窗: baseline
Small high-density lipoprotein (s-HDL) particle concentration plasma measured by Ion Mobility Assay. For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Small HDL (s-HDL) Particle Concentration in Plasma at Week 24
时间窗: Week 24
Small high-density lipoprotein (s-HDL) particle concentration in plasma measured by Ion Mobility Assay at Week 24 For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)
时间窗: 24 weeks
Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)
次要结局
未报告次要终点