Image Parkinson's Disease Progression Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Disease Progression
Intervention: Rasagiline; Placebo; Magnetic Resonance Imaging; functional Magnetic Resonance Imaging; Physical Function Performance Test
Intervention description: 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.
Intervention MeSH terms: Rasagiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 40 Years
Maximum age: 77 Years
Healthy volunteers: No
Keywords: Rasagiline

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  96 patients with clinically diagnosed PD. For the PD diagnosis, we will use the
             University of Kentucky PD brain bank diagnostic criteria implemented by a movement
             disorders trained neurologist. Only early stage PD within 5 years of diagnosis who
             have never taken rasagiline will be included. 5 years since diagnosis was chosen to
             focus on early stages of PD, where MAO-B inhibitors have shown the most promise. PD
             are eligible to participate if they are age 40-77, Hoehn and Yahr stage < or equal to
             2 when on medication, and able and willing to sign informed consent to be randomized
             to the placebo or active drug arm.

        Exclusion Criteria:

          -  As necessitated by the risks of Magnetic Resonance Imaging, patients who have any type
             of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or
             a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain),
             are not eligible for participation in the MRI portion of the study.

          -  Individuals who are claustrophobic will also be excluded from participation.

          -  Women who are or might be pregnant and nursing mothers are not eligible. Pregnancy
             tests will be carried out for each female subject prior to the MRI scan.

          -  Individuals with psychiatric disorders or dementia will be excluded, along with other
             neurologic and orthopedic problems that impair hand movements and walking.

          -  Individuals who have a history metalworking involving cutting processes such as
             grinding, filing, shaving, and threading, will need radiological clearance to
             participate in this study. Specifically, individuals who report a history of
             metalworking will be referred to Radiology at Shands University of Florida(UF) for an
             orbitofrontal x-ray. In addition, individuals who have sustained an eye injury
             involving metal will also be referred to Radiology at Shands UF for an orbitofrontal
             x-ray. Shands at UF will provide a written report stating whether the individual is
             safe for imaging at 3 Tesla. All expenses related to this procedure will be covered by
             the PI.

          -  Patients with a prior stroke or brain tumor are excluded. Patients will be excluded if
             they are unwilling to comply with the study procedures.