Current Research Studies at Clinical Research Department at Alexian Brothers Neurosciences Institute

Listed below are the current research studies being offered at Neurosciences Clinical Research

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of the study drug. Seeking patients with Mild to Moderate Alzheimer's Disease who are Apolipoprotein E4 Carriers or Non-Carriers

This trial tests the hypothesis that removing amyloid protein from the brain may halt the progression of Alzheimer's disease. The drug functions as an antibody which will bind to the amyloid deposit and remove it from the brain. The drug will be administered by infusion for a total of 6 infusions over a period of 13 months. The subject must be on a stable dose of a cholinesterase inhibitor and/or Namenda (Memantine).

A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients with Parkinson's Disease

The purpose of this study is to test the effectiveness of Droxidopa in treating orthostatic hypotension (low blood pressure, especially when changing positions from seated or lying down to standing) in patients with Parkinson's Disease.

Droxidopa works by replenishing depleted norepinephrine in the peripheral nervous system, which stimulates vasoconstriction, thus providing improvement in orthostatic hypotension. This study is approximately 14 weeks long. Medication will be taken orally three times daily. Eligible patients must be 18 years of age or older, have a diagnosis of Parkinson's disease, and have symptomatic orthostatic hypotension.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients with Mild to Moderate Alzheimer's Disease

This study is evaluating the effectiveness of MABT5102A in the inhibition of disease progression in patients with mild to moderate Alzheimer's disease. MABT5102A, a monoclonal antibody to Beta-Amyloid (Abeta), is hypothesized to stop the formulation of new amyloid plaques in the brain. This medication is administered through either injection or intravenous infusion. This study is approximately 85 weeks long and visits will occur every 2 weeks for the duration of the trial.

A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease

 Psychotic symptoms occur in 20% to 40% of patients with PD in advanced stages of the disease, manifesting primarily as hallucinations and delusions. Currently, there is no proven safe and effective course of treatment for PDP. The purpose of this study is to evaluate the safety and efficacy of Pimavanserin compared to placebo in the treatment of Parkinson's Disease psychosis (PDP). Pimavanserin may offer antipsychotic benefit in this subject population with an acceptable risk profile. It will be administered at 40 mg and will be compared to a placebo arm, with approximately 85 subjects per arm across 50 sites.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of the safety and effectiveness of Immune Globulin Intravenous (HUMAN), 10% Solution (IGIV, 10%) for the treatment of Mild to Moderate Alzheimer's Disease (AD)

This study assesses the safety and efficacy of intravenous Gammagard Liquid® (IGIV 10%) as treatment for patients with mild to moderate Alzheimer's disease (AD). Preliminary findings suggest that IGIV treatment can improve or stabilize cognitive status and improve global clinical outcome as compared to placebo. This is a double-blind study in which patents will be randomly assigned (at a ratio of 1:1:1) to receive IGIV infusions at one of two doses (0.2 or 0.4 g/kg of body weight), or placebo. Qualified patients will receive an infusion every two weeks for a total of 36 infusions over 71 weeks. The total study duration is 18 months. Additional study procedures include: MRI, ECG, Neurological and Physical Exams, Cognitive Testing and Laboratory Assessments. This study is for patients from 50 to 89 years of age who have mild to moderate Alzheimer's disease. Patients must be on a stable dose of Alzheimer's disease medication(s) for at least 12 weeks prior to screening.

This is a randomized, double blind, placebo and active control Phase 2 dose ranging study evaluating the efficacy and safety of ABT-126 in subjects with Mild to Moderate AD. The study will consist 24-week treatment period and a post treatment period. Subjects will be randomized to 1 of 5 treatments groups ( placebo, 25mg ABT, 50mg ABT, 75mg ABT, donepezil (Aricept).

This drug can improve cognition, specifically learning and memory by directly stimulating nicotinic receptors in the brain. These receptors increase the release of Acetylcholinesterase Inhibitor in brain regions mostly involved in learning. Because of the selective nicotinic receptor stimulation the drug can also limit side effects due to cholinesterase inhibitor such as Aricept, Exelon and Galantamine. All subjects must be off all current AD treatment for 60 days prior to enrollment.

This is a randomized, double blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of ABT-126 in subjects with mild to moderate AD on a stable dose (at least 90 days) of Acetylcholinesterase Inhibitor (Aricept or Exelon Patch). The study will consist of a 24-week treatment period and a post treatment period. Subjects will be randomly assigned to one of two ABT-126 dose (2Smg or 7Smg) arms or placebo in a 1:1:1 ratio.

This drug can improve cognition, specifically learning and memory by directly stimulating nicotinic receptors in the brain. These receptors increase the release of Acetylcholinesterase Inhibitor in brain regions mostly involved in learning. Because of the selective nicotinic receptor stimulation the drug can also limit side effects due to cholinesterase inhibitor such as Aricept, Exelon and Galantamine.

A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta

Teriflunomide  is an oral medication that works by stopping immune cells from dividing—thus reducing numbers of both B cells and T cells; so it prevents T and B cells from attacking neurons in the CNS.

The EFC6058 study evaluates safety and effectiveness of teriflunomide in the treatment of relapsing forms of Multiple Sclerosis (MS) when added to a patient’s current regimen of interferon-beta, (INF-β). 

Eligible patients will randomly be assigned to receive (in addition to their current therapy) teriflunomide at 14 mg or 7 mg, or a placebo pill once daily. Patients have a 33% (or 1:1:1) chance of being randomized to each possible dose.  This is an open-ended study that will last a minimum of 68 weeks, and is expected to last approximately until September 2013.  Visits are every four weeks until week 24, and then change to approximately every six weeks for the duration of the study.  Follow-up visits will occur at four and sixteen weeks after the treatment phase of the study.

This study is for men and women between 18 and 55 years of age who have a relapsing form of multiple sclerosis.  To be eligible, patients must be taking a stable dose of INF-β for at least six months, and have had an MS relapse within the last year after being on their current INF-β medication for at least three months. 

A Phase 3, 12-Week Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease

This study evaluates the safety and efficacy the medication preladenant at doses of 2mg twice daily and 5 mg twice daily as compared to placebo in subjects with moderate to severe Parkinson’s disease.

This study is for people with moderate to severe Parkinson’s disease from 30 to 85 years of age who have received prior therapy with L-dopa for 1 or more years immediately prior to screening with positive response to L-dopa therapy.  The treatment phase of the study lasts 12 weeks, and patients  may be eligible to participate in an extension.