A Prospective, Randomized, Double-Blind, Dose-Comparison Concurrent Control Study to Assess the Safety and Tolerability of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- Frequency of Treatment-emergent Adverse Events (Safety)
研究概览
简要总结
This study is evaluating the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild to moderate Alzheimer's disease.
详细描述
This is a randomized, double-blind, dose-comparison concurrent control study to assess the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered by intravenous (IV) infusion to subjects with mild to moderate Alzheimer's disease.
Subjects will be randomized 1:1 to a low dose or a high dose of active treatment in a double-blind manner. All subjects will receive one infusion per day at the randomized dose for 5 consecutive days during Week 1 and, again, during Week 13 (for a total of 10 doses per subject). All IV infusions will take place at an inpatient research unit while the follow-up visits after each treatment period will be on an outpatient basis. Subjects will participate for a total of 6 months in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 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 AD based upon the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
- •MMSE Score 12-24 inclusive
- •Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4
- •Provided a signed and dated informed consent form (either the subject and/or subject's legal representative as well as the trial partner)
排除标准
- •Evidence of clinically relevant neurological disorder(s) other than probable AD
- •History of blood coagulation disorders or hypercoagulability; any concurrent use of an anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
- •Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine, Axona, vitamin E supplementation or selegiline within 3 months prior to screening.
- •Heart disease (or history thereof), as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure (New York Association Class II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood
- •Prior hypersensitivity reaction to any human blood product or intravenous infusion; any known clinically significant drug allergy.
- •Treatment with any human blood product, including transfusions and intravenous immunoglobulin, during the 6 months prior to screening.
- •History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke, anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.
- •Hemoglobin <10 g/dL in women; and <11 g/dL in men.
研究组 & 干预措施
GRF6019 Low Dose
Subjects will receive a low dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
干预措施: GRF6019 (Drug)
GRF6019 High Dose
Subjects will receive a high dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
干预措施: GRF6019 (Drug)
结局指标
主要结局
Frequency of Treatment-emergent Adverse Events (Safety)
时间窗: Baseline to 6 months
Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
次要结局
- The Mini-Mental State Examination (MMSE)(Baseline and 6 months)
- Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADASCog/11)(Baseline and 6 months)
- The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB)(Baseline and 6 months)
- The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)(Baseline and 6 months)
- The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)(Baseline and 6 months)
- The Neuropsychiatric Inventory Questionnaire (NPI-Q)(Baseline and 6 months)