NCT02256306已完成不适用
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.
研究概览
简要总结
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable Alzheimer's disease (NIA-AA criteria)
- •Mini-Mental State Examination (MMSE) score 12-24
- •Availability of a study partner who knows the patient well and is willing to accompany the subject to all trial visits, to participate in questionnaires and to complete daily journal assessments
排除标准
- •Pregnancy or unwilling to use adequate birth control method for duration of and 6 months beyond study participation
- •Positive for Hepatitis B, Hepatitis C or HIV at screening
- •Any other condition or situation that the investigator believes may interfere with the safety of the subject 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
- •Uncontrolled hypertension
- •Renal failure
- •Prior intolerance to intravenous fluids
- •Recent history of uncontrolled atrial fibrillation
- •IgA deficiency (by history)
- •Related to medications or other treatments:
- •Any concurrent use of an anticoagulant therapy. Antiplatelet drugs (e.g., aspirin or clopidogrel) are acceptable
- •Initiation or change in the dosage of a cholinesterase inhibitor or memantine during the trial. A participant already on a cholinesterase inhibitor or memantine must be on a stable dose for at least one month prior to Screening
- •Concurrent participation in another treatment trial for Alzheimer's disease. If there was prior participation, the last dose of the investigational agent must have been at least 6 months prior to Screening
- •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, in the investigator's opinion, interfere with cognition. Intermittent treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted, provided that no dose is administered within the 72 hours preceding any cognitive assessment
- •Related to magnetic resonance imaging:
- •Claustrophobia
- •Any metallic surgical implant, like a pacemaker or clip that is incompatible with 3T MRI.
- •Certain metallic implants like joint replacements may be permitted, provided that specific manufacturer specifications are available and that the device is known to be safe for 3T MRI.
研究组 & 干预措施
Young Donor Plasma
Experimental
Subjects will receive 1 unit of plasma, once weekly for 4 weeks.
干预措施: Plasma (Other)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.
时间窗: 9 weeks
次要结局
- Change on the 13-item ADAS-Cog(9 weeks)
- Change on the Trail-Making Test(9 weeks)
- Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB)(9 weeks)
- Change on the Functional Activities Questionnaire (FAQ)(9 weeks)
- Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)(9 weeks)
- Change on the Geriatric Depression Scale(9 weeks)
- Change on the Neuropsychiatric Inventory Questionnaire (NPI-Q)(9 weeks)
研究者
Sharon Sha
Principle Investigator
Stanford University
研究点 (1)
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