EUCTR2018-000148-24-NO进行中（未招募）1 期
Safety and efficacy of plasma transfusion from exercise-trained donors in patients with early Alzheimer’s disease: the ExPlas Study
orwegian University of Science and Technology0 个研究点目标入组 60 人开始时间: 2018年4月10日最近更新:
适应症
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
- 60
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
- •?Signed informed consent
- •?Age 50-75 years
- •?Diagnosis AD in early phase according to the IWG-2 criteria (42)
- •?In-vivo evidence of Alzheimer´s pathology (one of the following):
- •oDecreased Aß42 together with increased t-tau or p-tau in CSF
- •?Increased tracer retention on amyloid PET
- •?Mini-Mental State Examination (MMSE) Score =20
- •?Availability of a next of kin who knows the patient well and is willing to accompany the subject
- •to all trial visits and give information about the patient’s functional level
- •?The patient is judged fit for the study and capable to cooperate in treatment and follow-up.
- •?Ability to communicate in Norwegian or another Scandinavian language
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •?Pregnancy or unwilling to use adequate birth control for the duration of and 6 months beyond
- •study participation. Defined according to Clinical Trial Facilitation Group document
- •Recommendations related to contraception and pregnancy testing in clinical trials”
- •?Positive for Hepatitis B, Hepatitis C or HIV at screening
- •?Not qualified to give consent at inclusion
- •?Any other condition judged to interfere with the safety of the patient or the intent and conduct
- •of the study
- •Related to medical history:
- •?Anaphylaxis
- •?Prior adverse reaction to any human blood product
- •?Any history of a blood coagulation disorder or hypercoagulability
- •?Congestive heart failure, defined as any previous heart failure hospitalization, or current
- •symptomatic heart failure in New York heart Association class =II with reduced, mid-range or
- •preserved ejection fraction
- •?Coagulation defect or hypercoagulopathy
- •?Uncontrolled hypertension
- •?Renal failure
- •?Prior intolerance to intravenous fluids
- •?Recent history of uncontrolled atrial fibrillation
- •?Bone marrow transplant
- •?IgA deficiency
- •?Severe protein S deficiency
- •?Thrombocytopenia (platelets < 40 x 109/L)
- •?Contraindication for Octaplasma
- •Related to medications or other treatments:
- •?Any concurrent use of anticoagulant therapy, clopidogrel or acetylsalicylic acid/dipyridamole
- •in combination
- •?Initiation or change in the dosage of a acetylcholine esterase inhibitor (AChEI) or memantine
- •during the trial (week 0-52). Participants will be urged to start on AChEI when diagnosis is
- •communicated, and must be on a stable dose for at least one month prior to screening
- •?Concurrent participation in another treatment trial for AD. If there was prior participation, the
- •last dose of the investigational agent must have been given at least 6 months prior to
- •screening, except if the patient received placebo medication
- •?Treatment with any human blood product, including intravenous immunoglobulin, during the
- •6 months prior to screening or during the trial
- •?Concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-
- •acting opioids, or other medications that are judged to interfere with cognition. Intermittent
- •treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted,
- •provided that no dose is administered within 72 hours prior to cognitive assessment
- •Related to magnetic resonance imaging:
- •?Claustrophobia
- •?Any metallic surgical implant, like a pacemaker or clip incompatible with MRI
- •Certain metallic implants like joint prostheses may be permitted, provided that specific manufacturer specifications are available, and that the device is known to be safe for 7T MRI. In case a patient is not eligible for the 7T scanner, the 3T scanner will be used
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