The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): pramipexole; Sinemet CR
Intervention type(s): Drug; Drug
Intervention description(s): tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.; tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
Other intervention name(s): Sifrol; Sinemet CR 250' (Levodopa 200mg, and 50mg carbidopa)
Intervention MeSH terms: Levodopa; Carbidopa; Pramipexole; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: De Novo parkinson's disease; initial treatment; pramipexole; Levodopa; Parkinson's disease-related spatial covariance pattern