Image Parkinson's Disease Progression Study
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - 77 |
| Updated: | 3/27/2019 |
| Start Date: | December 2016 |
| End Date: | December 2020 |
| Contact: | Nieci Black |
| Email: | nblack@ufl.edu |
| Phone: | 352-294-1771 |
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.
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.
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.
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.
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.
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