EUCTR2013-000307-17-DE进行中(未招募)1 期
A Phase II/III multicenter, randomized, double-blind, placebo-controlled platform trial of potential disease modifying therapies utilizing biomarker, cognitive, and clinical endpoints in dominantly inherited Alzheimer's disease (DIAD)
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 740
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants must meet ALL inclusion criteria, including EYO:
- •1. -10 to +10 EYO (secondary prevention population): within -10 to +10 years (inclusive) of the estimated age at symptom onset, CDR 0 to 1, inclusive; known eligible mutation carrier or at 50% risk (affected parent or sibling); or
- •2. -25 to -11 EYO (primary prevention population): within 11 to 25 years younger than their estimated age at symptom onset, CDR 0, known carrier or mutation in their family pedigree; if the at-risk parent is deemed a non-carrier at any point, participants will be withdrawn from study.
- •3. Are able and willing to complete the main study-related testing, evaluations, and procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 725
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Participants will be excluded if they have a major or unstable illness that would prevent trial participation or are unable to complete main study-related testing. Exclusions include MRI contraindications, required anticoagulation and pregnancy. Participants who know they are mutation non-carriers are not eligible.
研究者
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