EUCTR2011-001598-25-ES进行中（未招募）1 期
A multicenter, randomized, controlled study to evaluate the efficacy and safety of short-term plasma exchange followed by long-term plasmaphereses with infusion of human albumin combined with intravenous immunoglobulin in patients with mild-moderate Alzheimer's disease.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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.Males or females between 55-85 years of age at the time of signing of the informed consent document.
- •2.A diagnosis of AD (NINCDS-ADRDA criterion), and Mini-mental Status Examination (MMSE) score between =18 and =26.
- •3.Current stable treatment with acetylcholine esterase inhibitors (AChEIs) for the previous three months.
- •4.The patient and a close relative or legal representative must read the patient information sheet, agree to participation in the trial, and then sign the informed consent document (the patient personally and the close relative/legal representative).
- •5.The patient must be able to follow the study protocol, receive the treatment in the established time period, and continue during the follow-up interval.
- •6.A brain Computed Axial Tomography (CAT) or Magnetic Resonance Imaging (MRI) study, obtained in the 12 months prior to recruitment, showing the absence of cerebrovascular disease, must be available.
- •7.A stable care taker must be available, and must attend the patient study visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1.Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:
- •Hypocalcemia (Ca++ < 8.7 mg/dL).
- •Thrombocytopenia (<100,000/?L).
- •Fibrinogen <1.5 g/L.
- •Prothrombin time (Quick) p<60% versus control.
- •Beta-blocker treatment and bradycardia <60/min.
- •Treatment with angiotensin-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions).
- •2.Hemoglobin < 10 g/dL
- •3.Difficult venous access precluding plasma exchange.
- •4.A history of frequent adverse reactions (serious or otherwise) to blood products.
- •5.Hypersensitivity to albumin or allergies to any of the components of Albutein®.
- •6.History of immunoglobulin A (IgA) deficiency.
- •7.Known allergies to Flebogamma® DIF components such as sorbitol.
- •8.History of thromboembolic complications of intravenous immunoglobulins.
- •9.Plasma creatinine > 2 mg/dL.
- •10.Uncontrolled high blood pressure.
- •11.Liver cirrhosis or any liver problem with alanine aminotransferase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
- •12.Heart diseases, including antecedents of coronary disease and heart failure.
- •13.Participation in other clinical trials, or the reception of any other investigational drug in the three months prior to the start of the study.
- •14.Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, toxic habits, etc.).
- •15.Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
- •16.Fewer than six years of education.
- •17.Prior behavioral disorders requiring pharmacological treatment, including insomnia
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