Image Parkinson's Disease Progression Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      Parkinson's disease (PD) is a neurodegenerative brain disorder that impairs the ability to
      perform functions such as grooming, dressing, cooking, and other activities of daily living.
      PD affected between 4.1 and 4.6 million people worldwide in 2005, and it is projected that up
      to 9.3 million people will be affected by 2030. Although current pharmacological therapies
      provide beneficial effects on motor symptoms of the disease (tremor, rigidity, and
      bradykinesia), intolerable disability eventually develops in most patients. A
      disease-modifying therapy that slows disease progression is a major unmet medical need in PD.
      Numerous agents have neuroprotective effects in pre-clinical laboratory models, but none have
      been shown to have indisputable disease-modifying effects in clinical trials for patients
      with PD.

      The purpose of this research study is to investigate how the brain and motor behavior changes
      in PD over time in response to rasagiline which is a monoamine oxidase-B(MAO-B) inhibitor.
      The drug rasagiline will be tested in this study as the MAO-B inhibitor. Rasagiline has been
      prescribed for many years to treat symptomatic Parkinson's disease. It is FDA approved for
      the treatment of Parkinson's disease but has not been shown to slow disease progression. The
      outcome and impact of this study will provide the first evaluation of MAO-B inhibitors at
      slowing the progression of the nigrostriatal pathway using advanced Magnetic Resonance
      Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) methods in PD.
    

Detailed description: 
      Participants will receive baseline testing to confirm a diagnosis of Parkinsonism and to
      determine eligibility in the research study. Half of the participants in this study will be
      in a group that will receive the study drug (rasagiline), and half will be in a group that
      will receive a placebo. A placebo is a pill that is made to look like the study drug, but it
      does not contain any active ingredients. A computer algorithm will randomly decide group
      assignment (like the flip of a coin). The study drug will be provided at the end of the first
      visit. The participants will not know which study drug is received, placebo or rasagiline.

      During the research study the following test may occur: (1) questionnaires about quality of
      life and depression; (2) tests to measure strength and motor function; (3) tests to measure
      cognition; (4) orientation session to learn a precision gripping task; (5) functional MRI
      scan of the brain; (6) structural MRI scan of the brain.
    

Intervention name(s): Rasagiline; Placebo; Magnetic Resonance Imaging; functional Magnetic Resonance Imaging; Physical Function Performance Test
Intervention type(s): Drug; Other; Device; Device; Other
Intervention description(s): Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.; A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.; This test will be performed at baseline and one year.; This test will be performed at baseline and one year.; This test will be performed at baseline and one year.
Other intervention name(s): Azilect; MAO-B inhibitor; MRI; fMRI
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rasagiline