Research

Clinical Trials

The Department of Neurology is actively involved in clinical trials to determine the effectiveness of new treatments for neurological conditions including epilepsy, multiple sclerosis, stroke and neuromuscular diseases and disorders. If you are interested in receiving additional information or participating in a trial, please e-mail or call the persons listed below. Please note that enrollment is currently closed for some of the trials.

Mild Cognitive Impairment (MCI) / Early Alzheimer’s Disease

IRB number

IRB18-1580

Title

The AMARANTH Clinical Trial Research Study

Site Principal Investigator

James Mastrianni, MD, PhD 
Clinical Trials Coordinator: Breanna Bertacchi, BA

Purpose

 

The University of Chicago Memory Center for Comprehensive Care and Research on Memory Disorders is currently enrolling individuals ages 55 to 85 years, with early Alzheimer’s disease (patients with mild cognitive impairment due to Alzheimer’s disease and patients diagnosed with mild dementia of the Alzheimer’s type) to participate in the clinical trial AMARANTH to help us examine an investigational drug that may have some effect on the brain changes associated with Alzheimer’s disease.

Eligibility

  • Be between 55 and 85 years old

  • Have either: Experienced gradual and progressive change in memory function over more than 6 months (the study team will assess whether this is due to Alzheimer’s disease) OR  Been diagnosed with mild Alzheimer’s disease or mild cognitive impairment (MCI)

  • Have a relative, friend or caregiver who would be willing to be your study partner throughout the study.

Funding

APDM Wearable Technologies, Pfizer, Biogen

Duration

The study will last for approximately 24 months (about 8 weeks to see if you qualify, plus 2 years of treatment, then 4-6 weeks of follow-up).

Contact Name

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

 

IRB number

IRB18-1580

Title

 

Imaging Dementia Evidence for Amyloid Scanning (IDEAS) Study

Mild Cognitive Impairment (MCI)

Site Principal Investigator

James Mastrianni, MD, PhD
Co-Principal Investigator: Daniel Applebaum, MD
Clinical Trials Coordinator: Breanna Bertacchi, 

Purpose

 

 

 

 

The purpose of the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) Study is to examine how brain imaging helps guide your doctor in how to treat your mild cognitive impairment, and whether these changes in your treatment plan lead to better health outcomes.

A one-time brain imaging, called the amyloid PET (positron emission tomography) scan, will be requested by your doctor as part of your standard of care.

The amyloid PET brain imaging will look at the build-up of amyloid plaques in the brain which has been linked with Alzheimer’s disease and other related diseases. The brain imaging is not being performed as part of the research; the actual part of the research study is to examine whether the imaging guides your medical treatment and improves health outcomes.

Eligibility

 

 

 

 

 

  • Be 65 years or older

  • Be a Medicare beneficiary

  • Have a diagnosis of mild cognitive impairment (MCI) or dementia (will be determined by The Memory Center) and have Alzheimer’s disease as a diagnostic consideration

  • Meet additional study criteria

  • Medicare will pay for your amyloid PET imaging exam as a covered benefit.

Funding

Alzheimer’s Association in collaboration with the American College of Radiology, and the American College of Radiology Imaging Network (ACRIN).

Contact Name

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu

Status Accrual

Soon to be open for enrollment

Ataxias

IRB number

IRB16-1570

Title

Natural History of Genetic Modifiers in Spinocerebellar Ataxias

Site Principal Investigator

Christopher Gomez, MD, PhD 

Purpose

The purpose of this study is to develop a cohort of individuals with SCA to learn more about the disease, find out how it progresses over time, and what may be the best way to measure progression.

Eligibility

SCA 1, 2, 3, 6, 7, 8, or 10 diagnosis

Funding

National Ataxia Foundation (NAF)

Visits

Yearly for up to 5 years

Contact Name

Hannah Casey

Phone/Email

773-832-4610 /  hannahcasey@uchicago.edu 

Status Accrual

Active, recruiting

 

IRB number

CIRB18-0570

Title

Clinical Trial Readiness for SCA 1 and SCA3

Site Principal Investigator

Christopher Gomez, MD, PhD 

Purpose

The purpose of this study is to create the largest cohort of participants with the genetic mutation but have no ataxia symptoms or who have early-stage SCA 1 or SCA 3 and to collect data necessary for future clinical trials. 

Eligibility

confirmed SCA 1, 3 diagnosis; at-risk for SCA 1 or SCA 3

Funding

NIH PAR-16-020

Visits

Yearly for up to 5 years

Contact Name

Hannah Casey

Phone/Email

773-832-4610 /  hannahcasey@uchicago.edu 

Status Accrual

Active, recruiting

 

IRB number

IRB18-1580

Title

Instrumented Data Exchange for Ataxia 

Site Principal Investigator

Christopher Gomez, MD, PhD 

Purpose

The purpose of this study is to learn how to better measure progression of SCA 1, 2, 3, 6, and FA. 

Eligibility

SCA 1, 2, 3, 6, or FA diagnosis or healthy control

Funding

APDM Wearable Technologies, Pfizer, Biogen

Visits

Every 6 months for 2 years

Contact Name

Hannah Casey

Phone/Email

773-832-4610 /  hannahcasey@uchicago.edu 

Status Accrual

Active, recruiting

 

IRB number

IRB16-1547

Title

A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia 

Site Principal Investigator

Christopher Gomez, MD, PhD 

Purpose

To compare the efficacy of BHV-4157 vs. placebo on ataxia symptoms in subjects with SCS after 8 weeks of treatment as measured by the total score on the SARA scale.

Funding

Biohaven Pharmaceuticals

Contact Name

Cindy Jimenez

Phone/Email

(773) 702-1848 / Email: cindyj@uchicago.edu 

Status Accrual

Active, Not recruiting

 

IRB number

IRB18-1753

Title

A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia 

Site Principal Investigator

Christopher Gomez, MD, PhD 

Purpose

To compare the efficacy of troriluzole versus placebo on ataxia symptoms I subjects with SCA Type 1 and Type 2, after 48 weeks of treatment as measured by the total score on the Modified F-SARA

Funding

Biohaven Pharmaceuticals

Contact Name

Cindy Jimenez

Phone/Email

(773) 702-1848 / Email: cindyj@uchicago.edu 

Status Accrual

Active, Not recruiting

Multiple Sclerosis Program

RRMS or Relapsing Progressive MS, Untreated or on Therapy

IRB number

 

Title

Monthly infusion of a drug that may repair MS lesions, added on to current therapy

Site Principal Investigator

P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani

 

Purpose

 

 

 

 

 

 

 

 

 

 

 

AbbVie:  Elezanumab in Relapsing MS (anti-Repulsive Guidance Molecule).  [M18-918: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Relapsing Forms of Multiple Sclerosis].

Diagnosis of relapsing remitting or relapsing progressive multiple sclerosis for at least 2 years, with documented evidence of exacerbation in past 2 years, but not in past 6 months

An EDSS score of 2.0-6.5, slowed walking, or arm dysfunction

Able to perform and complete all protocol visits and procedures

Untreated for 6-12 months, or on MS therapies such as glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®), or ocrelizumab (Ocrevus®) with no dose changes for at least 6 months.

But, no treatment with any of the following medications or procedures within the 6 months:  Natalizumab, Cyclosporine, Azathioprine, Methotrexate, Mycophenolate mofetil, Intravenous immunoglobulin (IVIg, any interferon or IV, oral, or intrathecal corticosteroids.

No treatment within 1 year with:  cyclophosphamide, rituximab, or alemtuzumab.

No treatment ever with cladribine or mitoxantrone.

Duration

1 year

Eligibility

18 -55 y/o, male or non-pregnant female, BMI 18 to 45

Funding

 

Contact Name

Mildred Valentine

Phone/Email

773.702.9812 / mvalenti@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

MS Exacerbations

IRB number

 

Title

 

Mallinckrodt:  Effects of ACTHAR on MRI and immunity during MS relapses with ACTH injections for treatment of MS exacerbations, followed by monitoring

Site Principal Investigator

PI: Adil Javed.  Co-PI: X Feng.  Sub-I’s: Anthony T Reder, T Carrol, Veronica P Cipriani

Purpose

This study is to test whether plasma or CSF CoQ10 could be a biomarker on patients with MSA 

Diagnosis of acute MS attack with documented evidence new active MRI lesion

An EDSS score of 0-8

Able to perform and complete all protocol visits and procedures

No recent medium-dose or high-dose steroids such as prednisone or methylprednisolone

Eligibility

8 or older, male or female

Duration

up to 2.5 years

Funding

 

Contact Name

Mildred Valentine

Phone/Email

 

773.702.9812 / mvalenti@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

Neuromuscular Disorders Program

IRB number

 

Title

 

A Double-Blind, Randomized, Multicenter, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Site Principal Investigator

Kourosh Rezania MD

Purpose

The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of CIDP compared with placebo.

Eligibility

 

 

 

 

 

 

  • Diagnosis of typical CIDP

  • Disability defined by an INCAT Disability Scale score of 1-9

  • Receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks)

  • Male or female, aged 18 years or older

  • Patients should not have diabetes

  • Patients with multifocal motor neuropathy or IgM paraproteinemia cannot be included 

Funding

Novartis

Contact Name

Elizabeth Londo

Phone/Email

 

Status Accrual

Active, Recruiting

Neuro Oncology Program – Brain and Nervous System Cancer Clinical Trials

IRB number

CIRB15-1357

Title

EAY131: Molecular Analysis for Therapy Choice (MATCH)

Site Principal Investigator

Daniel Catenacci

Purpose

Details

Eligibility

Are you part of the research staff and cannot see your study listed here? Please contact the cancer center IT Team .

 

IRB number

IRB15-1476

Title

The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins

Site Principal Investigator

Steven Chmura

Purpose

Details

Eligibility

Are you part of the research staff and cannot see your study listed here? Please contact the cancer center IT Team .

 

IRB number

IRB16-0767

Title

A Phase I Study of Safety and Tolerability of Acetazolamide with Temozolomide in Adults with Newly Diagnosed or Recurrent Malignant Glioma

Site Principal Investigator

Bakhtiar Yamini

Purpose

Details

Eligibility

Are you part of the research staff and cannot see your study listed here? Please contact the cancer center IT Team .

Movement Disorder/Parkinson's Disease Program

IRB number

IRB17-0531

Title

Caffeine and other possible biomarkers in Parkinson’s disease

Site Principal Investigator

Tao Xie, MD PhD

Purpose

This study to test whether plasma or urine caffeine or its metabolites could be a biomarker of PD patients

Eligibility

Newly diagnosed PD patients not on any anti-PD medications

Funding

Michael J Fox Foundation

Contact Name

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

 

IRB number

IRB17-0998

Title

Characteristics of African American people with Parkinson’s disease: A hospital based study at the University of Chicago of the African American community in Chicago’s south side.

Site Principal Investigator

Tao Xie, MD PhD

Purpose

This study is looking for subjects with PD of African American or Caucasian background to study the clinical features and genetic profile of African American patients with PD.

Eligibility

PD patients

Funding

Parkinson’s Foundation

Contact Name

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu    

Status Accrual

Active, recruiting

 

IRB number

 

Title

Neuroimaging biomarkers in parkinsonism: differentiating subtypes and tracking disease progression.

Site Principal Investigator

Tao Xie, MD PhD

Purpose

To study the biomarkers in brain MRI imaging in PD, PSP and MSA.

Eligibility

Typical PD, MSA and PSP patients

Funding

NINDS/NIH

Contact Name

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

 

IRB number

IRB17-1681

Title

A study on plasma and CSF CoQ10 as a biomarker on patients with multiple system atrophy (MSA).

Site Principal Investigator

Tao Xie, MD PhD and  Mahesh Padmanaban, MD

Purpose

This study is to test whether plasma or CSF CoQ10 could be a biomarker on patients with MSA 

Eligibility

Typical PD, MSA and PSP patients

Funding

Private donation

Contact Name

Breanna Bertacchi

Phone/Email

773-834-1688 / bbertacchi1@neurology.bsd.uchicago.edu

Status Accrual

Active, recruiting

Stroke Program

IRB number

IRB17-1681

Title

MISTIE III - Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (NCT01827046).

Site Principal Investigator

Issam Awad MD

Purpose

 

The MISTIE trial will evaluate blood clot removal using minimally invasive surgery with recombinant tissue plasminogen activator in order to provide information on the relationship between blood clot removal and functional outcome.

Eligibility

 

 

 

 

  • Patients ages 18 to 80 with spontaneous supratentorial intracerebral hemorrhage

  • Symptoms lasting less than 24 hours prior to diagnostic CT scan

  • Clot size stable on follow-up CT scan after 6 hours

  • Historical Rankin score of 0 or 1

Funding

 

Contact Name

Agnieszka Stadnik, MS

Phone/Email

astadnik@surgery.bsd.uchicago.edu

Status Accrual

Active, recruiting

Movement Disorders/Parkinson's Disease Program:

Active, Not Recruiting

IRB Number: IRB16-0559

Title: A multicenter, open-label, long-term treatment study of intravenously administered BIIB092 in patients with progressive supranuclear palsy (PSP) who participated in study CN002003 (CN002004)

Site Principal Investigator: Tao Xie, MD PhD

Purpose: This study is to test a new drug to treat PSP. We will collect demographic, clinical information, samples of blood and CSF, and MRI images

Eligibility: PSP patients between 41-86 years, have completed the CN002003 study, must have a reliable caregiver.

Funding: Biogen

Status Accrual: Active, not recruiting

IRB Number: IRB17-1545

Title: An extension study of ABBV-8E12 in progressive supranuclear palsy (M15-563)

Site Principal Investigator: Tao Xie, MD PhD

Purpose: This study is to test a new drug to treat PSP. We will collect clinical information, demographics, samples of blood and CSF, and MRI images.

Eligibility: PSP patients between 45-85 years, with PSP symptoms for no more than 5 years, must be able to ambulate 5 steps independently, must have completed AbbVie M15-562 trial.

Funding: Abbvie

Status Accrual: Active, not recruiting

IRB number: IRB17-0446

Title: A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of intravenously administered BIIB092 in participants with progressive supranuclear palsy (CN002012)

Site Principal Investigator: Tao Xie, MD PhD

Purpose: This study is to test a new drug to treat PSP. We will collect clinical information, demographics, samples of blood and CSF, and MRI images.

Eligibility: PSP patients between 45-85 years, with PSP symptoms for no more than 5 years, must be able to ambulate 10 steps independently

Funding: Biogen

Status Accrual: Active, not recruiting

Multiple Sclerosis Program

Genentech:  CHORDS study, Ocrelizumab switch from failed disease-modifying drugs in RRMS. P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani. Completely Enrolled.

MedDay:  Effect of MD1003 (high-dose biotin) in progressive multiple sclerosis: a randomized double-blind placebo controlled study.  P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani.  Completely Enrolled.

Biogen:  AFFINITY trial, BIIB003 (Anti-LINGO) added to other MS therapies in Progressive MS.  P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani.  Completely Enrolled.

Genentech:  MN39159 CONSONANCE trial, An Open-Label, Single-Arm, 4-Year Study To Evaluate Effectiveness And Safety Of Ocrelizumab in Progressive MS.  P.I., Anthony Reder; with Adil Javed, BGW Arnason, and Veronica Penyak Cipriani.  Completely Enrolled.

NMO Program

Chugai:  Phase I trial of an anti-IL-6 MAb in neuromyelitis optica (NMO).  P.I., Adil Javed; with AT Reder, BGW Arnason, and VP Cipriani.  Completely Enrolled.

MedImmune:  Phase I trial of an anti-CD19 MAb in neuromyelitis optica (NMO).  P.I., Adil Javed; with AT Reder, BGW Arnason, and VP Cipriani. Completely Enrolled.