Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 39 for:    fMRI | Recruiting, Active, not recruiting Studies | Parkinson Disease

Image Parkinson's Disease Progression Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02789020
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida

Brief Summary:

Parkinson's disease (PD) is a neurodegenerative brain disorder that impairs the ability to perform functions such as grooming, dressing, cooking, and other activities of daily living. PD affected between 4.1 and 4.6 million people worldwide in 2005, and it is projected that up to 9.3 million people will be affected by 2030. Although current pharmacological therapies provide beneficial effects on motor symptoms of the disease (tremor, rigidity, and bradykinesia), intolerable disability eventually develops in most patients. A disease-modifying therapy that slows disease progression is a major unmet medical need in PD. Numerous agents have neuroprotective effects in pre-clinical laboratory models, but none have been shown to have indisputable disease-modifying effects in clinical trials for patients with PD.

The purpose of this research study is to investigate how the brain and motor behavior changes in PD over time in response to rasagiline which is a monoamine oxidase-B(MAO-B) inhibitor. The drug rasagiline will be tested in this study as the MAO-B inhibitor. Rasagiline has been prescribed for many years to treat symptomatic Parkinson's disease. It is FDA approved for the treatment of Parkinson's disease but has not been shown to slow disease progression. The outcome and impact of this study will provide the first evaluation of MAO-B inhibitors at slowing the progression of the nigrostriatal pathway using advanced Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) methods in PD.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Rasagiline Other: Placebo Device: Magnetic Resonance Imaging Device: functional Magnetic Resonance Imaging Other: Physical Function Performance Test Phase 2

Detailed Description:

Participants will receive baseline testing to confirm a diagnosis of Parkinsonism and to determine eligibility in the research study. Half of the participants in this study will be in a group that will receive the study drug (rasagiline), and half will be in a group that will receive a placebo. A placebo is a pill that is made to look like the study drug, but it does not contain any active ingredients. A computer algorithm will randomly decide group assignment (like the flip of a coin). The study drug will be provided at the end of the first visit. The participants will not know which study drug is received, placebo or rasagiline.

During the research study the following test may occur: (1) questionnaires about quality of life and depression; (2) tests to measure strength and motor function; (3) tests to measure cognition; (4) orientation session to learn a precision gripping task; (5) functional MRI scan of the brain; (6) structural MRI scan of the brain.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Image Parkinson's Disease Progression Study
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rasagiline
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Drug: Rasagiline
Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
Other Names:
  • Azilect
  • MAO-B inhibitor

Device: Magnetic Resonance Imaging
This test will be performed at baseline and one year.
Other Name: MRI

Device: functional Magnetic Resonance Imaging
This test will be performed at baseline and one year.
Other Name: fMRI

Other: Physical Function Performance Test
This test will be performed at baseline and one year.

Placebo Comparator: Placebo
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Other: Placebo
A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.

Device: Magnetic Resonance Imaging
This test will be performed at baseline and one year.
Other Name: MRI

Device: functional Magnetic Resonance Imaging
This test will be performed at baseline and one year.
Other Name: fMRI

Other: Physical Function Performance Test
This test will be performed at baseline and one year.




Primary Outcome Measures :
  1. Change in free-water accumulation in the substantia nigra [ Time Frame: Baseline and one-year ]
    12-month study in PD to watch the effect of an MAO-B inhibitor on the progressive increase of free-water accumulation in the substantia nigra.

  2. Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen, M1, and supplementary motor area(SMA). [ Time Frame: Baseline and one-year ]
    12-month study in PD to watch the effect of an MAO-B inhibitor on BOLD signal in the posterior putamen, M1, and SMA.


Secondary Outcome Measures :
  1. Changes in PD motor symptoms and bradykinesia [ Time Frame: Baseline and one-year ]
    Cognitive and motor testing batteries such as the Brief Test of Attention, Digit Span, Dynamic Gait Index, Epworth Sleepiness Scale, EQ5D Questionnaire, Montreal Cognitive Assessment, Purdue Pegboard Test, and STROOP Color and Word Test will be administered to measure changes in the progression of the PD motor symptoms and bradykinesia.

  2. Changes between the groups on MRI for free-water in the substantia nigra [ Time Frame: Baseline and one-year ]
    A diffusion MRI will be performed to measure the free-water in the substantia nigra(SN) section of the brain.

  3. Changes between the groups on fMRI [ Time Frame: Changes from baseline to 1 year ]
    Participants will use their hand to squeeze an MRI compatible grip force transducer in the MRI unit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 96 patients with clinically diagnosed PD. For the PD diagnosis, we will use the University of Kentucky PD brain bank diagnostic criteria implemented by a movement disorders trained neurologist. Only early stage PD within 5 years of diagnosis who have never taken rasagiline will be included. 5 years since diagnosis was chosen to focus on early stages of PD, where MAO-B inhibitors have shown the most promise. PD are eligible to participate if they are age 40-77, Hoehn and Yahr stage < or equal to 2 when on medication, and able and willing to sign informed consent to be randomized to the placebo or active drug arm.

Exclusion Criteria:

  • As necessitated by the risks of Magnetic Resonance Imaging, patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), are not eligible for participation in the MRI portion of the study.
  • Individuals who are claustrophobic will also be excluded from participation.
  • Women who are or might be pregnant and nursing mothers are not eligible. Pregnancy tests will be carried out for each female subject prior to the MRI scan.
  • Individuals with psychiatric disorders or dementia will be excluded, along with other neurologic and orthopedic problems that impair hand movements and walking.
  • Individuals who have a history metalworking involving cutting processes such as grinding, filing, shaving, and threading, will need radiological clearance to participate in this study. Specifically, individuals who report a history of metalworking will be referred to Radiology at Shands University of Florida(UF) for an orbitofrontal x-ray. In addition, individuals who have sustained an eye injury involving metal will also be referred to Radiology at Shands UF for an orbitofrontal x-ray. Shands at UF will provide a written report stating whether the individual is safe for imaging at 3 Tesla. All expenses related to this procedure will be covered by the PI.
  • Patients with a prior stroke or brain tumor are excluded. Patients will be excluded if they have cognitive impairment as assessed by a Montreal Cognitive Assessment score < 23 or if they are unwilling to comply with the study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789020


Contacts
Layout table for location contacts
Contact: Nieci Black 352-294-1771 nblack@ufl.edu

Locations
Layout table for location information
United States, Florida
Laboratory for Rehabilitation Neuroscience Recruiting
Gainesville, Florida, United States, 32611
Contact: Nieci Black    352-294-1771    nblack@ufl.edu   
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: David E Vaillancourt, PhD. University of Florida

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02789020     History of Changes
Other Study ID Numbers: IRB201600537-N
R01NS052318 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available without any personal identifiers included.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Florida:
Rasagiline
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs