Clinical Trials
Providence Brain Institute is involved in several clinical trials for investigational medications for Alzheimer's disease, ALS, multiple sclerosis, stroke and more.
Parkinson’s disease
TVP-1012/PM103
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add-on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson’s Disease (ANDANTE: Add-ON to Dopamine Agonists in early-stage patients Needing enhanced Treatment Efficacy).
The primary objective is to assess the efficacy of rasagiline 1 mg as add-on treatment to dopamine agonist therapy in early PD patients not optimally controlled on dopamine agonists.
Principal investigator: Richard Rosenbaum, M.D.
Sponsor: Teva Neuroscience
Contact: Britt Ash, clinical trials coordinator, at britt.ash@providence.org or 503-963-3128
Alzheimer's disease
BMS 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.
The purpose of this study is to determine the safety, tolerability and potential pharmacodynamic effects of BMS-708163 125 mg/day versus placebo in patients with prodromal Alzheimer’s disease (AD) for a minimum of approximately 104 weeks.
Principal investigator: Michael Mega, M.D., Ph.D.
Sponsor: Bristol-Myers Squibb Research and Development
Contact: Chad Parks, clinical research coordinator, at chad.parks@providence.org or 503-216-2736
Wyeth 3133K1-3001
A 24-Week, Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of Rivastigmine Patch 15 cm2 versus Rivastigmine Patch 5 cm2 on Activities of Daily Living and Cognition in Patients with Severe Dementia of the Alzheimer’s Type.
The purpose of this study is to evaluate the efficacy over 24 weeks of a higher dose of rivastigmine transdermal patch (15 cm2) over a lower dose (5 cm2) of the patch, in patients with severe dementia of the Alzheimer’s type.
Principal investigator: Michael Mega, M.D., Ph.D.
Sponsor: Novartis Pharmaceuticals
Contact: Desirae Burkley, clinical research coordinator, at desirae.burkley@providence.org or 503-216-1025
Amyotrophic lateral sclerosis (ALS)
Protocol # BIO-ALS-01
A Multicenter Study for the Validation of ALS Biomarkers. The purpose of this study is to collect both blood and cerebrospinal fluid (CSF) samples from healthy people, people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron diseases, as well as other neurodegenerative diseases. Through comparison of these samples, researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to diagnose ALS and monitor disease progression.
Principal investigator: Kimberly Goslin, M.D., Ph.D.
Sponsor: Massachusetts General Hospital
Contact: Britt Ash, clinical trials coordinator, at britt.ash@providence.org or 503-963-3128
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.
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.
Contact: Providence ALS Center or Kimberly Goslin, M.D., Ph.D., at 503-963-3100
Protocol # CEF-ALS-2006
Clinical Trial of Ceftriaxone in Subjects with Amyotrophic Lateral Sclerosis. The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).
Principal investigator: Kimberly Goslin, M.D., Ph.D.
Sponsor: Massachusetts General Hospital
Contact: Britt Ash, clinical trials coordinator, at britt.ash@providence.org or 503-963-3128
Multiple sclerosis
Pacific Northwest Multiple Sclerosis Patient Registry
The goals are to accurately estimate the prevalence and geographic distribution of MS patients, to create a database for ongoing epidemiological and health services research in MS, and to develop an interactive MS network to provide training and improve access to specialized MS care.
Principal investigator: Stanley Cohan, M.D., Ph.D.
Contact: study staff at pacificNWms.org or 503-216-1022
Biogen Protocol 101JC402
JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-2.
The purpose of this study is to better understand whether antibody to JC virus may be used to predict whether a patient is at higher or lower risk of developing progressive multifocal leukoencephalopathy (PML). There is no drug treatment provided in this study. Participation is expected to last two years, and blood samples will be collected from patients for up to three times during this period.
Principal investigator: Stanley Cohan, M.D., Ph.D.
Contact: Desirae Burkley, clinical research coordinator, at desirae.burkley@providence.org or 503-216-1025
Biogen Protocol 109MS201
An Open-Label, Multicenter Study in Subjects with Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA).
The purpose of this open-label study is to assess the safety, tolerability and efficacy of BG00012 administered in combination with IFNβ (Avonex, Rebif or Betaseron) or GA (Copaxone) in patients with relapsing-remitting MS.
Principal investigator: Stanley Cohan, M.D., Ph.D.
Contact: Chad Parks, clinical research coordinator, at chad.parks@providence.org or 503-216-2736
Biogen Protocol 205MS301
Multicenter, Double-Blind, Parallel-Group, Monotherapy, Active-Control Study to Determine the Efficacy and Safety of Daclizumab High Yield process (HYP) versus Avonex (Interferon β-1a) in Patients with Relapsing-Remitting MS.
The purpose of this study is to compare the efficacy of daclizumab HYP with Avonex and assess the safety of long-term treatment with daclizumab HYP in patients with MS.
Principal investigator: Stanley Cohan, M.D., Ph.D.
Contact: Chad Parks, clinical research coordinator, at chad.parks@providence.org or 503-216-2736
ITN 035A1
A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults with Relapsing-Remitting Multiple Sclerosis.
The purpose of this study is to evaluate the ability of Abatacept to affect the rate of progression of MS as defined by the accumulation of new inflammatory MRI lesions in patients with RRMS, and to assess the safety and efficacy of Abatacept on the clinical progress of MS.
Principal investigator: Stanley Cohan, M.D., Ph.D.
Contact: Chad Parks, clinical research coordinator, at chad.parks@providence.org or 503-216-2736
Stroke
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.
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.
Principal investigators: David Antezana, M.D., Lisa Yanase, M.D.
Sponsor: Johns Hopkins University
Contact: Desirae Burkley, clinical research coordinator, at desirae.burkley@providence.org or 503-216-1025
