a Pilot Follow-up Study of Investigating the Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Chinese Patients With Early Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Longitudinal Change of Brain Network Activity
研究概览
简要总结
Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous clinical trial indicated that initial pramipexole owns advantage over levodopa regarding motor complications, on the contrary, less adverse effect like freezing and severe somnolence favors initial treatment of levodopa. Thus, it remains controversial that initiation of which medication will be better for those patients with early PD.
Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can represent the network activity of brain and severity of PD. Based on the literatures and our previous data, the investigators hypothesize that PDRP will be served as a biomarker to help us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which might be able to provide further evidence for clinicians to address the above critical issue.
详细描述
CALM-PD study found that Pramipexole can reduce the occurrence of motor complication compared with Levodopa used as initiative treatment, but it still remains debatable that initiation of which medication will be better for those patients with De Novo PD.
PDRP (Parkinson's disease-related spatial covariance pattern) is a biomarker which can represent the network activity of cortico-striato-pallido-thalamocortical pathways and highly reproducible with stable network activity in individual subjects. The study published in "J Neuroscience" in 2010 showed that the abnormal PDRP antecede the appearance of motor signs by about 2 years, indicating PDRP might be a very promising biomarker for identifying PD at its early stage. Moreover, PDRP is able to represent the progression and severity of PD as well. It was reported that Levodopa can reduce the PD-related network activity, and the degree of network suppression correlates with the clinical improvement. However, there is no study currently showing the impact of pramipexole on brain PDRP network compared with levodopa as initiative treatment.
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
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
- •Hoehn&Yahr staging (H&Y) I-II
排除标准
- •Atypical Parkinsonism
- •Pregnant or breast-feeding women
- •those with abnormal Liver/kidney function
- •those participating other clinical trials within 30 days before being enrolled for this trial.
研究组 & 干预措施
pramipexole
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
干预措施: pramipexole (Drug)
Levodopa
Sinemet CR CR， Controlled Release
干预措施: Sinemet CR (Drug)
结局指标
主要结局
Longitudinal Change of Brain Network Activity
时间窗: twice, baseline and 1 year after baseline
The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score). The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.
次要结局
- Unified Parkinson's Disease Rating Score (UPDRS II, III)(three times: baseline, 10 weeks, 1 year)
- Hoehn&Yahr (H&Y) Staging(twice baseline and 1 year)
- Parkinson's Disease Questionnaire (PDQ39)(twice baseline and 1 year)
- Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).(twice, at 10 weeks(V2) and 1 year(V5))