NCT03713957已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 29
- 主要终点
- Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.
详细描述
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for the subjects will be approximately 7 months.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.
- •Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible Parkinson's disease dementia according to Movement Disorder Society's Clinical Diagnostic criteria.
- •Score on the Montreal Cognitive Assessment (MoCA) of 13-
- •Modified Hoehn and Yahr Stages 1-
- •Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.
排除标准
- •History of blood coagulation disorders or hypercoagulability.
- •Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
- •Prior hypersensitivity reaction to any human blood product or any IV infusion.
- •Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
- •History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins.
- •Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing
- •Hemoglobin < 10 g/dL in women and < 11 g/dL in men.
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
干预措施: Placebo (Other)
GRF6021
Experimental
Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
干预措施: GRF6021 (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Approximately 24 Months
Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
次要结局
- Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.(Change from Baseline to Week 20)
- The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.(Change from Baseline to Week 16)
- The Montreal Cognitive Assessment (MoCA) Score.(Change from Baseline to Week 16)
- The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.(Change from Baseline to Week 20)
- The Schwab and England Activities of Daily Living (SE-ADL) Scale.(Change from Baseline to Week 24)
- The Clinical Impression of Severity Index - PD (CISI-PD).(Change from Baseline to Week 24)
- The Geriatric Depression Scale-15 (GDS-15).(Change from Baseline to Week 20)
- The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).(Change from Baseline to Week 20)
- The Digital Clock Drawing Test (dCDT).(Change from Baseline to Week 20)
- Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.(Change from Baseline to Week 20)
研究者
研究点 (29)
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