2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to assess whether GPI 1485 has the ability to delay or stop disease
      progression and improve symptoms in patients with Parkinson's disease (PD) that is already
      being treated with a dopamine agonist therapy. Whether the drug is working will be assessed
      by evaluating clinical endpoints such as UPDRS scores and by evaluating images, obtained by
      SPECT scan, of brain activity. Participants in the study will be given either placebo or GPI
      1485 treatment. The duration of the study is 2-years and patients are required to complete 12
      safety visits and 3 SPECT scans. SPECT scans will be taken before, after 1-year, and after
      2-years of treatment with GPI 1485. In completing the SPECT scan, patients will be injected
      with a radioactive investigational drug b-CIT and pictures taken using a Single Photon
      Emission Computed Tomography (SPECT) camera.
    

Detailed description: 
      In this phase II study, the investigational new drug (not approved by the FDA) GPI 1485 is
      being assessed for its ability to delay or stop disease progression and improve symptoms in
      patients with mild to moderate Parkinson's disease (PD). These potential effects of GPI 1485
      are based on animal studies in which the drug was shown to both protect nerves from damage
      and to regrow damaged nerves. Participants in this study will be randomly assigned to receive
      either GPI 1485 or placebo (inactive pill). GPI 1485 will be supplied as an oral tablet
      formulation to participants enrolled in the study. Participants randomly assigned to receive
      GPI 1485 will be required to take four tablets four times a day by mouth. GPI 1485 matching
      placebo will also be supplied as an oral tablet formulation. Participants randomly assigned
      to placebo will be required to take four placebo tablets four times a day by mouth. The
      duration of this study is 24 months which includes 12 clinical visits at one of 21
      participating sites and three imaging visits to Molecular NeuroImaging (MNI) in New Haven
      Connecticut. At MNI, participants will be injected with a radioactive investigational drug
      b-CIT to obtain images of the activity in the brain with Single Photon Emission Computed
      Tomography (SPECT). This will evaluate whether GPI 1485 slows or delays the loss of brain
      activity in patients with mild to moderate PD. During this study you will also have other
      clinical evaluations including a physical exam, blood work, ECG (tracing of your heart
      rhythm), and urinalysis. Tests specific to Parkinson's disease will also be performed
      including: Unified Parkinson's Disease Rating Scale (UPDRS), Dyskinesia Rating Scale,
      Bilateral finger-tapping test, and Parkinson's Disease Sleep Scale (PDSS). In addition
      assessments of your health and mood will be done.
    

Intervention name(s): GPI 1485
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; SPECT Scanning