- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531086
Idiopathic Parkinson's Progression and Dopamine Transporter SPECT
Exploring Dopamine Transporter Single-photon Emission Computer Tomography Quantification as a Measure of Disease Progression in Idiopathic Parkinson's Disease
Study Overview
Detailed Description
Background: Idiopathic Parkinson's disease (PD) is a neurodegenerative disorder involving loss of dopaminergic neurons in the substantia nigra and subsequent dysfunction in the striatum. The diagnosis of PD remains a clinical diagnosis based on patient history and physical exam findings. In 2011 the FDA approved the use of DaTscanTM Ioflupane I123, a radiopharmaceutical to be used as an adjunct diagnostic tool in combination with single photon emission computed tomography (SPECT) to evaluate striatal dopamine transporter (DAT) distribution in patients with an unclear diagnosis of parkinsonism vs essential tremor (Bajaj et al., 2013). Because the loss of DAT binding in the striatum reflects the loss of dopaminergic neurons in parkinsonism, DAT SPECT is considered a highly sensitive test for these disorders (Ba and Martin, 2015). The major clinical uncertainty with DAT SPECT imaging is whether or not quantitative analysis can be utilized to determine progressive degeneration over time and serve as a quantitative biomarker for changes in striatal dopaminergic integrity in correlation with clinical worsening in patients with idiopathic PD. In 3 small studies using two other ligands, 18F-dopa and I123β-CIT, striatal uptake declined annually by 12.5-13%, and 2.4% - 7.1%, respectively (Morrish et al., 1996; Nurmi et al., 2000; Pirker et al., 2012). Current analytical methodologies have focused on establishing differences between the PD and control groups, but have not explored the technology for tracking disease progression with Ioflupane I123, using the patient as their own control. The goal of this proposed study is to evaluate the validity of quantitative measurements in DAT SPECT scans in determining disease progression in subjects with idiopathic PD. Data from this pilot study would contribute significantly to future applications for investigating translational research strategies to restore dopaminergic cell function in PD. More specifically, the ability of autologous peripheral nerve grafts, acting as a source of neuroregenerative growth factors, is being investigated in PD subjects undergoing deep brain stimulation (Craig van Horne, PI). As there are no current biomarkers for PD progression, it is critical to evaluate the potential for DAT SPECT to serve as an analytical tool for the quantification of dopaminergic functional integrity. This study is designed to test the ability of DAT SPECT to be used as an effective methodology for tracking disease progression where patients serve as their own control.
Objectives: The specific aim is to evaluate the ability of DAT SPECT quantification to track disease progression in subjects with idiopathic Parkinson's disease by comparing baseline scans to those obtained 12 months later. The quantified DAT SPECT data will be clinically correlated to the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor scores and Hoehn and Yahr stage obtained at baseline and at 12 months.
Study Design: This will be an initial phase of a prospective study evaluating DAT SPECT quantification in subjects with idiopathic Parkinson's disease. The clinical severity of PD will be measured by MDS-UPDRS motor scores and the Hoehn and Yahr scale. Data will be acquired at baseline, and 12 months. The subject will serve as their own control.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky Department of Neurology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between the ages of 40-75
- Able to give informed consent
- Show a positive response to carbidopa/levodopa
- Hoehn and Yahr score 1-3
Exclusion Criteria:
- Under the age of 40 or over the age of 75
- Unable to give informed consent
- Nonresponsive to carbidopa/levodopa
- Hoehn and Yahr score 4-5
- Unable to discontinue medications which might interfere with DaTscan TM imaging
- Inability to lie still for 30-45 minutes during CT-SPECT imaging
- Pregnancy or Nursing
- Severe kidney function impairment
- Unable to tolerate iodine containing products
- Patients with deep brain stimulation (DBS) or a history of any other brain surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ioflupane I123
Participants will receive Ioflupane I123 as an adjunct diagnostic tool in combination with single photon emission computer tomography (SPECT) to evaluate striatal dopamine transporter.
Patients will serve as their own control longitudinally.
|
Ioflupane I 123 will be administered IV push prior to SPECT imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dopamine transporter binding in idiopathic Parkinson's Disease progression.
Time Frame: 1-year
|
Patients will receive dopamine transporter SPECT imaging at baseline and after one year to investigate the ability of this technique to quantitatively assess neurodegeneration in the substantia nigra.
|
1-year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie Gurwell, PhD, PA-C, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 42475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Ioflupane I 123
-
GE Healthcarei3 StatprobeCompletedParkinsonian SyndromesUnited States, France
-
Wisconsin Institute for Neurologic and Sleep Disorders...GE Healthcare; Medical College of Wisconsin; Wisconsin Parkinson AssociationUnknownParkinson Disease | Movement DisordersUnited States
-
Institute for Neurodegenerative DisordersTerminatedAlzheimer's DiseaseUnited States
-
Molecular Insight Pharmaceuticals, Inc.Completed
-
Mayo ClinicEnrolling by invitationDementia | Mild Cognitive Impairment | Parkinsonism | REM Sleep Behavior DisorderUnited States
-
Molecular Insight Pharmaceuticals, Inc.CompletedAcute Coronary SyndromeUnited States, Canada
-
Alseres Pharmaceuticals, IncUnknownParkinsonian SyndromesUnited States
-
GE HealthcareCompletedCongestive Heart FailureUnited States
-
Institute for Neurodegenerative DisordersTerminatedAlzheimer's DiseaseUnited States
-
Ake NorbergCompleted