EUCTR2019-000604-15-IT进行中（未招募）1 期
Multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II study aimed at evaluating the efficacy and safety of Zinco Solfato” in Mild Cognitive Impairment due to Alzheimer’s disease - ZincAid
IVERSITÀ DEGLI STUDI G. D'ANNUNZIO CHIETI-PESCARA0 个研究点目标入组 215 人开始时间: 2020年10月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 215
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.50-80 years old. If Women, in menopause since at least 2 years.
- •2.nCp-Cu serum concentration > 1.6 µmol/L;
- •3.Stable presence of an informant family member, who is in contact with the subject for a period of time sufficient to assess him/her;
- •4.Release of written informed consent prior to participation in the study;
- •5.Capacity of full compliance with the protocol requirements (i.e.: assumption of the medicine per os, etc.);
- •6.Brain MRI performed within 12 months preceding or at the Screening Visit;
- •7.evidence of cerebral amyloidosis by scanning with Florbetapir (18F)-PET within 12 months or positive for CSF biomarkers of AD;
- •8.Diagnostic criteria for MCI .
- •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 157
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •1.Concomitant, in progress, or recurrent, severe, or unstable diseases and disabilities that may interfere with Cu metabolism, and with primary and secondary outcome evaluation, or may bias the assessment of the clinical or mental status of the subject or put the subject at special risk;
- •2.Concomitant severe or unstable cardiovascular diseases;
- •3.Concomitant primary neurodegenerative disorder besides MCI, or neurological or psychiatric disorders of any etiology;
- •4.Clinically significant anemia at the Screening Visit.
- •5.Prior treatments discontinuation before 3 month from the Screening Visit are allowed
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