Idiopathic Parkinson's Disease Clinical Trial
Official title:
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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