NL-OMON44729已完成2 期
Symptomatic treatment of vascular cognitive impairment - STREAM-VCI
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Outpatients
- •Objective executive dysfunction and/or memory impairment and imaging evidence of cerebrovascular disease (white matter changes (Fazekas=/>2, lacunar infarcts)
- •MMSE =/>16
- •Clinical Dementia Rating Score (CDR of 0.5-1)
- •No contraindication for treatment with a cholinesterase inhibitor or methylphenidate
- •Assessed by the treating neurologist as mentally capable of understanding the implications of study participation
- •Presence of an informant,/caregiver at the information visit and the signing of the informed consent
- •Signed informed consent by patient
排除标准
- •Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history taking and physical examinations obtained during the screening visit and/or at the study day as judged by the investigator;
- •Clinically relevant abnormal laboratory results, electrocardiogram (ECG) and vital signs, or physical findings at screening and/or at the start of the study day (as judged by the investigator);
- •Unwilling to or unable to stop smoking 12 hours before study day until 12 hours after the study day
- •Other causes that can explain cognitive symptoms
- •Use of doses of corticosteroids that in the opinion of the investigator may interfere pharmacodynamic measurements performed in the study.
- •Use of celiprolol or sotalol
- •Use of neuroleptics
- •Current use of centrally acting anticholinergics (e.g. oxybutinin, mebeverine, ipratropium(bromide)) Use of benzodiazepine within 48 hours before a study day
- •Current use of a CEI (rivastigmine, galantamine, donepezil)
- •Alcohol abuse (defined as use of alcohol despite significant areas of dysfunction, evidence of physical dependence, and/or related hardship due to alcohol)
- •Use of recreational drugs
- •Concomitant use of inhibitors of CYP2D6 (a/o kinidine, paroxetine, fluoxetine) or of CYP3A4 (a/o ketoconazole, ritonavir) unless on a stable dose and no expected upcoming changes in dosing.
- •Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
- •Any contra-indication for MRI
研究者
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