NCT01723228已完成4 期
A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 40
- 主要终点
- Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
研究概览
简要总结
This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on, parallel-group study to evaluate the effect of rasagiline on cognitive function in adults with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nondemented man or woman 45 through 80 years of age with idiopathic Parkinson's disease (PD) based on the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- •Hoehn and Yahr stage ≥ 1 (symptoms on only 1 side of the body) with treatment and ≤ 3 (mild-to-moderate bilateral disease; some postural instability; physically independent)
- •Mild cognitive impairment in Parkinson's disease based on the Movement Disorder Society (MDS) Task Force Diagnostic Criteria and the Montreal Cognitive Assessment (MoCA) rating scale (range, 20-25, inclusive)
- •Medically stable outpatient, based on the investigator's judgment
- •The patient is on a stable dopaminergic medication regimen for ≥ 30 days before entering the study (Screening/Baseline Visit)
- •Other inclusion criteria apply; please contact the site for more information
排除标准
- •Clinically relevant history of vascular disease (eg, stroke)
- •History of melanoma
- •History of deep brain stimulation (DBS)
- •Impaired hepatic function, based on the investigator's judgment
- •Psychosis or is receiving antipsychotic treatment
- •Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, based on the investigator's judgment
- •Other exclusion criteria apply; please contact the site for more information
研究组 & 干预措施
Rasagiline 1.0 mg/day
Experimental
Rasagiline 1 mg oral tablets once daily for 24 weeks
干预措施: Rasagiline (Drug)
Placebo
Placebo Comparator
Placebo oral tablets once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
时间窗: Baseline to Week 24 (or early discontinuation)
The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.
次要结局
- Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score(Baseline to Week 24 (or early discontinuation))
- Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score(Baseline to Week 24 (or early discontinuation))
- Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24(Week 24 (or early discontinuation))
- Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score(Baseline to week 24 (or early discontinuation))
- Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score(Baseline to Week 24 (or early discontinuation))
研究者
研究点 (40)
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