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Neuroscience Clinical Trials

Current Alzheimer's disease ongoing and enrolling studies including description

Study and Contact Information
Description

Expedition (sponsored by Eli Lilly)

Protocol #: H8A-MC-LZAX

Principal Investigator: Oleg V. Tcheremissine, MD

Coordinators: Dineen Gardner - 704-446-7511 & Megan Kramer - 704-446-0803

The purpose of this study is to help determine the safety and effectiveness of an investigational drug, solanezumab. “Investigational” means the study drug is currently being tested. It is has not been approved for routine clinical use nor for the use described in this study by the United States Food and Drug Administration (FDA). However, the FDA has allowed the use of this drug for research.

Researchers want to determine if solanezumab will slow mental and functional decline in individuals with mild Alzheimer’s.

Current, ongoing and enrolling ALS studies with a brief description

Study and Contact Information
Description

DPS (sponsored by MDA and ALSA)

Protocol #: HUD #10-0242

Principal Investigator: Benjamin Brooks, MD

Principal Investigator: Benjamin Brooks, MD

Coordinator: Cynthia Lary - 704-446-6063

This study is being done to find out if the NeuRx® Diaphragm Pacing System™ (DPS) will improve breathing function or prolong life span in people with ALS. The study also aims to compare measures of diaphragm function, dyspnea and quality of life between the standard of care group and DPS group.

Study participants must be at least 21. They will be randomized into one of two groups. One group (two-thirds of participants) will receive the DPS, and the other group (one-third of participants) will receive standard medical care for ALS. Participants receiving standard medical care will be the “control” group in order to tell whether the effects seen are truly from the DPS.

The study sponsors are the Muscular Dystrophy Association and the ALS Association.

Exercise (sponsored by Johns Hopkins)

Protocol #: NA_00022650

Principal Investigator: Benjamin Brooks, MD

Coordinator: Cynthia Lary - 704-446-6063

The purpose of this study is to see whether one type of exercise is tolerated better and is safer than another for people with ALS. Researchers also will collect information about how the body responds to exercise in people with ALS.

In this study, participants exercise in one of three ways: 1) weightlifting (resistance exercise); 2) stationary bicycling (endurance exercise) and; 3) range of motion/stretching exercise (the current “standard of care” for ALS patients). If resistance, endurance or range of motion exercise is shown to be well-tolerated and safe over 24 weeks, a larger trial will be planned to determining if exercise is beneficial to patients with ALS.

SOD1 (MDA)

Protocol #: None

Principal Investigator: Benjamin Brooks, MD

Coordinator: Rita Rouse - 704-446-1902

Researchers will collect a variety of information from participants’ medical records. That information includes ZIP code, gender, date of birth, month/year of ALS symptom onset, the month/year of permanent ventilation, and other pertinent data. This information will be entered into a database located at the study coordinating center, Washington University in St. Louis, MO. There are no clinic visits in this trial.

The study has two goals:
1. to collect survival data on every eligible subject and the rate of disease progression where available in order to define the natural history of familial ALS;
2. to determine if the natural history of SOD1 is different for certain areas of the US United States and Canada and determine if there are clusters of subjects in certain regions, which would provide guidance for future clinical trial site selection.

MDA Registry (sponsored by the Muscular Dystrophy Association)

Protocol #: None

Principal Investigator: Benjamin Brooks, MD

Coordinator: Rita Rouse - 704-446-1902

This is a study for children and adults who have been diagnosed with Amyotrophic Lateral Sclerosis (ALS), Duchenne Muscular Dystrophy (DMD), or Spinal Muscular Atrophy (SMA). The study is an ongoing data collection effort sponsored by the Muscular Dystrophy Association (MDA), known as the Patient Registry. The Patient Registry is designed to collect data – via a battery of questionnaires based on previous clinical assessments and patients’ own responses – on individuals with neuromuscular disease. Researchers want to better understand the disease progression and ultimately improve the care and survival of those with neuromuscular disease.

Subjects’ participation is expected to last for the duration of the study, which is continuous.

PRISM II

Protocol #: 12-AVR-401

Principal Investigator: Urvi Desai, MD

Coordinator: Rita Rouse - 704-446-1902

A study to assess the safety, tolerability, and effectiveness of NUEDEXTA (Dextromethorphan 20mg/Quinidine 10mg) in the Treatment of Pseudobulbar Affect. Pseudobulbar Affect symptoms include uncontrollable crying or laughter. The study currently is recruiting stroke and TBI (traumatic brain injury) patients only.

Current ongoing and enrolling MS studies with a brief description

Study and Contact Information
Description

M.U.R.D.O.C.K.

Protocol #: Pr00011196

Principal Investigator: Jill Conway, MD

Coordinator: Bridget Loven - 704-446-1987

The purpose of this project is to collect and store blood and urine samples and health information. Researchers can then study the stored materials.

Through such studies, we hope to find new ways to detect, treat, and maybe even prevent or cure health problems.

STRATEGY (sponsored by Biogen Idec, Inc.)

Protocol #: 109MS412

Principal Investigator: Jill Conway, MD

Coordinator: Megan Kramer – 704-446-0803

The study will be conducted as a retrospective, observational study of patients with RRMS transitioning treatment from Tysabri to Tecfidera in routine clinical practice.

The primary objective of the study is to evaluate relapse activity, as measured by the proportion of patients relapsed at 12 months. The secondary objective is to further evaluate relapse activity, defined as Annual Relapse Rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.

Approximately 500-700 patients are planned to be included in the study. There will be no dispensing of any study medication as part of this study.

EXPAND (sponsored by Novartis Pharmaceuticals)

Protocol #: CBAF312A2304

Principal Investigator: Jill Conway, MD

Coordinator: Maryanne Burdette - 704-446-1925

The purpose of this study is to evaluate the effectiveness and safety of BAF312 compared to placebo (a substance that looks like BAF312 but does not contain any active ingredient) in people with secondary progressive multiple sclerosis (SPMS). Subjects will take BAF312 or placebo once daily by mouth, as a tablet.

Approximately 8-10 people involved in this research study at CHS, and their participation will last for 23 to 42 months, but no more than 60 months. About 1,530 subjects with SPMS will join this study at approximately 250 to 300 centers worldwide.

Current ongoing and enrolling stroke studies including description

Study and Contact Information
Description

MISTIE III (sponsored by NIH/NINDS)

Protocol #: Pr00011196

Principal Investigator: Jason W. Todd, MD

Coordinators: Megan Kramer - 704-446-0803

The purpose of this study, sponsored by the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS), is to evaluate the recovery of participants who have had a hemorrhagic stroke – a kind of bleeding in the brain – and receive drug therapy along with minimally invasive surgery.

The drug being investigated is rt-PA (recombinant tissue plasminogen activator), a medication approved by the Food and Drug Administration (FDA) to treat for dissolving blood clots in the heart and brain. It is not approved for use in hemorrhagic stroke, and the FDA is allowing the use of rt-PA in this study

This 500-subject clinical trial also compares the recovery of patients who receive rt-PA and surgery to the recovery of participants who receive standard medical care – that is, no surgery and no investigational drug.

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