Study I7S-MC-HBEH (HBEH) is a multicenter, randomized (i.e. study in which people are assigned at random (by chance alone) to receive one of several clinical interventions), double-blind (i.e., neither the participant nor the person evaluating for the study knows what group the participant has been assigned to), parallel-group (i.e., a type of study where two groups of treatments, A and B, are given so that one group receives only A while another group receives only B.), placebo-controlled (i.e. one group will receive the study drug and the other will receive a substance that has no therapeutic effect, also known as placebo), fixed-dosage (i.e., the dosage will not change during the course of the study), Phase 2a study (i.e., a trial with the objective of assessing what dose is more effective in treating symptoms.) comparing various dosages of LY3154207 administered orally once a day with placebo over 12 weeks in subjects with mild-to-moderate Parkinson disease dementia (PDD).
The study includes a Screening Period (Visits 1 to 2) of a minimum of 7 days and up to 14 days, a 14-day Pretreatment Period (Visits 2 to 3), a 12-week Treatment Period (Visits 3 to 11), and a 14-day Safety Follow-Up Period (Visit 12).
Your participation will last about 17-18 weeks.
The purpose of this study is to find out how LY3154207 compares with placebo in treating memory and thinking problems in individuals with mild-to-moderate Parkinson's disease dementia.
This study will allow evaluation of long-term safety and clinical effects as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 (?core study', a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase III study to assess the safety and efficacy of AP-CD/LD versus IR CD/LD in fluctuating PD patients).
Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.
Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with motor deficits, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how tDCS affects motor areas in the brain. We propose using tDCS while recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. We expect this novel approach to broaden our understanding of tDCS application and possibly lead to therapeutic advances in this population.
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.
This study will assess the effectiveness, safety and tolerability of Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) compared to Immediate Release Carbidopa/Levodopa (IR CD/LD) (Sinemet) in patients with fluctuating Parkinson's disease (PD).
This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.
In this study, we plan to record electric fields (EF) in the brain while transcranial direct current stimulation (tDCS) is applied through the scalp. We will include patients who are scheduled to undergo deep brain stimulation (DBS) procedure to participate in the study, after explaining the procedures, answering any questions and receiving informed consent. The study might prolong the duration of the DBS procedure by a few minutes because of the time taken to apply tDCS. However, no other deviations from standard DBS procedures will be made. That is, no additional DBS electrode penetrations will be performed for research purposes - we will record from DBS electrodes that are being inserted exclusively as a part of clinical care.