Phase 2 N=90 Randomized Quadruple-blind Treatment

Image Parkinson's Disease Progression Study

Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02789020 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Change in Free-water Accumulation in the Substantia Nigra — 0.0009; 0.0041 arbitrary units (A.U.s)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rasagiline (Drug); Placebo (Other); Magnetic Resonance Imaging (Device); functional Magnetic Resonance Imaging (Device); Physical Function Performance Test (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Free-water Accumulation in the Substantia Nigra	0.0009; 0.0041	—
PRIMARY Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA).	-0.054; -0.086	—
SECONDARY Changes in Parkinson's Disease Motor Symptoms and Bradykinesia	1.04; 0.689	—
SECONDARY Changes Between the Groups on fMRI	-0.054; -0.086	—

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.

Eligibility 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 are unwilling to comply with the study procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02789020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.