eNeuro
Providence Brain Institute is involved in several clinical trials for investigational medications for Alzheimer's disease, ALS, multiple sclerosis, stroke and more.
Alzheimer's disease + MORE
ELAN 301
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Patients with Mild to Moderate Alzheimer's Disease who are Apolipoprotein E4 Non-Carriers.
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Patients are randomly chosen (by chance) to receive Bapineuzumab 1.0 mg/kg, Bapineuzumab 0.5 mg/kg, or placebo (normal saline) by infusion every 13 weeks. The study is approximately 83 weeks long with 15 visits.
Bapineuzumab is an investigational medication (not approved by the FDA). Patients must not be on cholinesterase inhibitors or memantine unless they have been receiving a stable dose of medication for at least 120 days prior.
Sponsor: Elan Pharmaceuticals Inc.
Principal investigator: Michael Mega, M.D., Ph.D.
If you are interested in this study, please contact Summer Carter, clinical research coordinator, at summer.carter@providence.org or 503-216-1034.
Wyeth 3133
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy and Safety Trial of Bapineuzamab (AAB-001, ELN115727) in Patients with Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E4 Carriers.
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Patients are randomly chosen (by chance) to receive bapineuzumab 0.5 mg/kg, or placebo (normal saline) by infusion every 13 weeks. The study is approximately 83 weeks long with 15 visits.
Bapineuzumab is an investigational medication (not approved by the FDA). Patients must not be on cholinesterase inhibitors or memantine unless they have been receiving a stable dose of medication for at least 120 days prior.
Sponsor: Wyeth Pharmaceuticals
Principal investigator: Michael Mega, M.D., Ph.D.
If you are interested in this study, please contact Desirae Burkley, clinical research coordinator, at desirae.burkley@providence.org or 503-216-1025.
Protocol CN156018
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients with Prodromal Alzheimer's Disease.
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The duration of study includes a maximum 42-day screening period followed by 24 weeks of treatment and a 28-week follow-up period. Patients will initially take either two capsules (50 mg) of BMS-708163 a day or matching placebo for the first two weeks, and then take five capsules (125 mg) of BMS-708163 or matching placebo for the remainder of the 24-week treatment period. BMS-708163 is a potent, selective and orally-active γ-secretase inhibitor.
Sponsor: Bristol-Myers Squibb Research and Development
Principal investigator: Michael Mega, M.D., Ph.D.
If you are interested in this study, please contact Chad Parks, clinical research coordinator, at chad.parks@providence.org or 503-216-2736.
Amyotrophic lateral sclerosis (ALS) + MORE
Biomarker Study
A Multicenter Study for the Validation of ALS Biomarkers. This is a blood and cerebrospinal fluid collection study. It will enroll amyotrophic lateral sclerosis (ALS) patients, patients with pure lower or pure upper motor neuron diseases, patients with neurological diseases whose symptoms are similar to those of ALS and healthy volunteers.
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The purpose of this study is to develop laboratory tests to diagnose ALS and to learn more about disease biomarkers which may help in the development of new ALS treatments. All study participants will have blood drawn. Patients who are having cerebrospinal fluid collected as part of their routine care will be asked to allow an extra amount collected for this study. Other study procedures include the collection of clinical information and completion of questionnaires. All required study visits and tests will be provided at no cost.
If you are interested in this study, please contact Providence ALS Center or Kimberly Goslin, M.D., at 503-963-3100.
Multiple sclerosis + MORE
EFC10531
A Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Teriflunomide in Patients with Relapsing Multiple Sclerosis Using Interferon-Beta 1a (Rebif®) as an Open-Label Rater-Blind Calibrator.
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This study is for patients with relapsing multiple sclerosis. Patients are randomly assigned (by chance) to one of two different doses of an investigational medication (not approved by the FDA) called Teriflunomide that is taken by mouth, or placebo (inactive look-alike capsule). Patients must not have had taken Copaxone, Avonex, Rebif or Betaseron in the previous three months, and cannot have taken Tysabri at any time.
Sponsor: Sonofi-Aventis Research and Development
Principal investigator: Stanley Cohan, M.D., Ph.D.
If you are interested in this study, please contact Chad Parks, clinical research coordinator, at chad.parks@providence.org or 503-216-2736.
DRI10566
A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Nerispirdine 50 mg, 100 mg and 200 mg in Patients with Multiple Sclerosis.
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This study is for patients diagnosed with any type of MS who are experiencing walking disability. Patients are randomly assigned (by chance) to one of three different doses of an investigational medication (not approved by the FDA) called nerispirdine that is taken by mouth, or placebo (inactive look-alike tablet). Patients must not have had a relapse in the past six months. Participation will last approximately 19 weeks total.
Sponsor: Sanofi-Aventis Research and Development
Principal investigator: Stanley Cohan, M.D., Ph.D.
If you are interested in this study, please contact Chad Parks, clinical research coordinator, at 503-216-2736.
Clot Lysis
Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III). A Multicenter, International, Double-Blind, Randomized Study Comparing the Use of EVD Combined with rt-PA to EVD Combined with Placebo for the Treatment of Intraventricular Hemorrhage.
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The primary objective is to define precisely the long-term effects of lysing ventricular blood clots with rt-PA on the functional outcomes of cerebral hemorrhage patients. Study duration is one year.
Sponsor: Johns Hopkins University
Principal investigators: David Antezana, M.D., and Lisa Yanase, M.D.
If you are interested in this study, please contact Summer Carter, clinical research coordinator, at summer.carter@providence.org or 503-216-1034. For more information, please visit www.cleariii.com.
Myocardial infarction and stroke + MORE
TRA 2°P – TIMI 50
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects with a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (Protocol No. P04737).
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This study is recruiting patients who have been diagnosed with a myocardial infarction (MI) or ischemic cerebrovascular disease (stroke) more than two weeks prior to study start, but less than 12 months ago. Patients are randomly assigned (by chance) to the investigational medication (not approved by the FDA) called SCH 530348 that is taken daily by mouth, or placebo (inactive look-alike tablet). Participation will last approximately four years.
All required study visits, tests and the medications will be provided at no cost.
Sponsor: Schering-Plough Research Institute
Principal investigator: Ted Lowenkopf, M.D.
If you are interested in this study, please contact Summer Carter, clinical research coordinator, at summer.carter@providence.org or 503-216-1034.
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