NCT07794670招募中2 期
A Phase 2b, Randomized, Double Blind, Placebo Controlled, Parallel Group Trial to Assess the Efficacy and Safety of Obicetrapib in Participants With Preclinical Alzheimer's Disease (SPINOZA Trial)
NewAmsterdam Pharma1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 52 in ptau 217
研究概览
简要总结
A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 三盲 (受试者、医护人员、研究者)
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
- participants with preclinical AD
排除标准
- APOE genotype not meeting protocol-defined eligibility criteria
研究组 & 干预措施
Obicetrapib
Experimental
10 mg Obicetrapib, once daily
干预措施: Obicetrapib 10 mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Matching placebo tablets (Drug)
结局指标
主要结局
Change from Baseline to Week 52 in ptau 217
时间窗: Baseline, Week 52
次要结局
- Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio(Baseline, Week 52)
- Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio(Baseline, Week 52)
- Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio(Baseline, Week 52)
- Change from Baseline to Week 52 in Alzheimer's disease related biomarker BD-tau(Baseline, Week 52)
- Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score(Baseline, Week 52)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT07794670
- 其他研究编号
- TA 8995 AD 2
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (明年)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 是否有结果
- 否
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