NCT00742417已完成2 期
Phase II Study to Evaluate the Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid, and Its Effects in Patients With Mild-moderate Alzheimer's Disease.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of plasma exchange with 5% albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients with mild-moderate Alzheimer's disease.
详细描述
A phase II study was conducted primarily to determine whether plasma exchange with 5% human albumin is able to modify the concentration of beta-amyloid peptide in cerebrospinal fluid (CSF) in patients with AD.
- There was two weeks for screening and randomization of both groups (treatment and control).
- The subjects were randomized in a 1:1 proportion.
After screening and randomization, treatment proceeded as follows:
- three weeks of intensive treatment with two plasma exchanges per week
- followed by a month and a half of maintenance treatment with one weekly plasma exchange, and
- finally, three months of treatment with one plasma exchange every two weeks.
The control group followed the same program, except for the plasma exchanges. After the treatment period ended, subjects followed-up for a 6-month period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of AD ( National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA] criterion), and Mini-mental Status Examination (MMSE) score between ≥18 and ≤
- •Current stable treatment with acetylcholine esterase inhibitors (AChEIs) for the previous three months.
- •A stable care taker must be available, and must attend the patient study visits.
- •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).
- •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.
- •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.
排除标准
- •Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters
- •A history of frequent adverse reactions (serious or otherwise) to blood products.
- •Hypersensitivity to albumin or allergies to any of the components of Albutein 5% Human Albumin.
- •Plasma creatinine > 2 mg/dL.
- •Uncontrolled high blood pressure.
- •Liver cirrhosis or any liver problem with alanine aminotransferase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
- •Heart diseases, including antecedents of coronary disease and heart failure.
- •Difficult venous access precluding plasma exchange.
- •Participation in other clinical trials, or the reception of any other investigational drug in the three months prior to the start of the study.
- •Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, toxic habits, etc.).
- •Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
- •Fewer than six years of education.
- •Prior behavioral disorders requiring pharmacological treatment, including insomnia.
研究组 & 干预措施
Albutein 5%
Experimental
Patients allocated to this arm underwent plasma exchange with Albutein 5%.
干预措施: Albutein 5% (Biological)
Control
Sham Comparator
干预措施: Control (Other)
结局指标
主要结局
Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.
时间窗: Baseline and up to week 44
Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.
次要结局
- Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).(Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44)
- Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).(Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.)
- P-Tau and Tau CSF Levels Throughout the Study.(Baseline, week 02, week 08, week 20, week 33 and week 44)
- Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).(Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.)
- Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)(Change from baseline at week 44)
- Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).(Change from baseline at week 44)
- Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.(Week 00 (baseline), week 20 and week 44)
- Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)(End of study)
研究者
研究点 (4)
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