The purpose of this study is to evaluate the safety of BIIB054 at several different doses. This study will also look at how BIIB054 affects your body (Pharmacodynamics) and how your body affects BIIB054 (Pharmacokinetics). It will also investigate how your immune system responds to BIIB054.
BIIB054 is an investigational product under development for the treatment of Parkinson's Disease. BIIB054 is an antibody, similar to proteins your body makes to try to rid itself of bacteria, viruses and certain other harmful agents. It is believed to work by attaching to molecules in your brain associated with Parkinson's Disease, called alpha-synuclein, and preventing them from causing damage.
To see how well the study drug works, it will be compared to a placebo in the study. A placebo is just like the study drug but it does not have any active ingredient. This is the best way for testing a new medicine in a research study because it keeps the study results from being influenced by what the research team thinks or hopes the new medicine might do.
BIIB054 or placebo will be administered by trained staff at the study center as an intravenous (IV) infusion, meaning that it will be given into one of your veins at a controlled rate. The duration of the infusion will be about 1 hour.
This study will be about 65 weeks. It includes a 5-week Screening period, a 48-week Treatment period, and a 12-week Follow?up period.
Subjects will take part in 1 screening visit and 13 dosing visits.
An investigator initiated pilot study of transcutaneous auricular vagal nerve stimulation (taVNS) in mild to moderate Parkinson's disease (PD).
We will assess whether nerve stimulation done on the surface of the skin, (called transcutaneous vagus nerve stimulation (taVNS)) is safe and effective in people with Parkinson's Disease (PD). A small electrical stimulator will be used to deliver electric pulses to a small portion of the left ear of the study participants. Participants will be assigned by chance to either 2 weeks of treatment with real taVNS, or a sham stimulation. The investigator will rate PD motor and cognitive symptoms before, during, and after the 2-week cycle. The investigators will also perform a number of blood and eye movement tests to check for the effectiveness of the stimulation, and perform regular safety checks.
The purpose of this study is to determine if a drug called Nilotinib is safe, if it can be tolerated by patients with PD and to learn if Nilotinib has the possibility of effectively treating PD symptoms. Nilotinib has been approved by the Food and Drug Administration (FDA) to treat certain types of cancer (leukemia) but is considered investigational in this study because it has not been approved for treating PD.
In this study, we are comparing two doses (150mg or 300mg) of Nilotinib to placebo (a pill that looks like the study drug but does not have any active medication in it, like a sugar pill). If you are eligible and choose to be in the study you will be randomly assigned to one of three groups, either:
? 150mg Nilotinib
? 300mg Nilotinib
All three groups will take two pills of the assigned type each day by mouth. ?Randomly' means that the group you are placed in is determined by chance (like tossing a coin). You will have a 2:1 chance of receiving Nilotinib. Neither you nor the researchers will know whether you are taking Nilotinib or placebo.
About 100 individuals will be interviewed and assessed, and 75 people will be asked to participate in this study at 25 clinics across the United States. Approximately 6 participants will be asked to participate in the study at MUSC.