NL-OMON52535
已完成
2 期
*A Phase 2b Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects with Mild Cognitive Impairment and Mild Dementia due to Alzheimer*s Disease.* - VIVIAD
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Vivoryon Therapeutics N.V.
- 入组人数
- 30
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Signed and dated written informed consent obtained from the subject in
- •accordance with local regulations
- •2\. Male or female, aged \>\= 50 to \<\= 80 years
- •3\. A biomarker profile reflecting Alzheimer's Disease (AD), according to the
- •Alzheimer Association \- National Institute on Aging (AA\-NIA) Research Framework
- •\[Jack et al 2018] defined as follows:
- •a) Screening CSF sample with an Aβ42 concentration of \<1000 pg/ml AND p\-tau \>19
- •pg/ml, or a ratio of p\-tau/Aβ42 of \>\=0\.024 as assessed by central laboratory,
- •(Elecsys assay), OR, in case of subjects in whom CSF sampling is not feasible
- •due to medical or technical reasons:
排除标准
- •1\. Significant neurological or psychiatric disorders, other than AD, that may
- •affect cognition
- •2\. Atypical clinical presentations of MCI due to AD or mild dementia due to AD,
- •such as the visual variant of AD (including posterior cortical atrophy),
- •frontal variant or the language variant (including logopenic aphasia)
- •3\. Moderate and severe dementia with a Mini Mental State Examination (MMSE)
- •score below 20
- •4\. History of (maximally six months from screening) or screening visit brain
- •MRI scan indicative of any other significant abnormality, including but not
- •limited to severe white matter hyperintensities (Fazekas score 3\), history or
结局指标
主要结局
未指定
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