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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 November 2021 |
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Main ID: |
NCT02789020 |
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Date of registration:
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20/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Image Parkinson's Disease Progression Study
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Scientific title:
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Image Parkinson's Disease Progression Study |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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96 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02789020 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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David E Vaillancourt, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida |
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Key inclusion & exclusion criteria
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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 are unwilling to comply with the study procedures.
Age minimum:
40 Years
Age maximum:
77 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Other: Placebo
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Device: Magnetic Resonance Imaging
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Drug: Rasagiline
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Other: Physical Function Performance Test
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Device: functional Magnetic Resonance Imaging
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Primary Outcome(s)
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Change in free-water accumulation in the substantia nigra
[Time Frame: Baseline and one-year]
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Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen, M1, and supplementary motor area(SMA).
[Time Frame: Baseline and one-year]
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Secondary Outcome(s)
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Changes between the groups on fMRI
[Time Frame: Changes from baseline to 1 year]
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Changes between the groups on MRI for free-water in the substantia nigra
[Time Frame: Baseline and one-year]
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Changes in PD motor symptoms and bradykinesia
[Time Frame: Baseline and one-year]
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Secondary ID(s)
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R01NS052318
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IRB201600537-N
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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