Identifying Biomarkers of Parkinson's Disease Using Magnetic Resonance Imaging (MRI)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01888185|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : September 18, 2019
|Condition or disease|
|Parkinson's Disease (PD) Parkinsonism Progressive Supranuclear Palsy (PSP) Multiple System Atrophy (MSA)|
|Study Type :||Observational|
|Actual Enrollment :||290 participants|
|Official Title:||Multimodal MRI Markers of Nigrostriatal Pathology in Parkinson's Disease|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 31, 2019|
Parkinson's Disease (PD)
Patients with a clinical diagnosis of PD (in various stages)
Progressive supranuclear palsy (PSP)
Patients with a clinical diagnosis of PSP (in various stages)
Multiple system atrophy (MSA)
Patients with a clinical diagnosis of MSA (in various stages)
Age and gender-matched adults free from neurological disease
- Differential roles of fractional anisotropy (FA) and R2* in PD detection and progression [ Time Frame: Change in roles of FA and R2* assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months. ]Substantia Nigra (SN) FA and R2* values in PD subjects will be compared with control subjects and correlated with clinical and behavioral measures.
- Nigrostriatal diffusion tensor imaging (DTI) and R2* differentiate PD from parkinsonian syndromes [ Time Frame: Assessed at baseline visit. ]DTI and R2* measures in both SN and striatal structures in PD, PSP, MSA and control subjects will be compared to assess sensitivity and specificity of individual and combined MRI measures in diagnosing PD.
- Iron(Fe)-related proteins in body fluids as biomarkers of PD [ Time Frame: Change assessed between baseline and 18 months. Change assessed between baseline and 36 months. Change assessed between 18 and 36 months. ]The protein profile in blood, urine, and cerebral spinal fluid (CSF), and their relationships to clinical and MRI measure will be interrogated with the focus being on Fe-related proteins such as hepcidin, ferritin, and transferrin.
- MRI and postmortem pathological correlation [ Time Frame: From baseline until date of death from any cause within 5 years for patient participants who succumb to their disease ]Postmortem brain analysis on patients who succumb to their disease during the study will be performed in order to inform the relationship of the biomarkers to clinical diagnosis (PD, PSP, MSA) and clinical milestones as well as to inform the pathological underpinnings of the R2* and DTI measures. In addition to standard postmortem diagnostic tests (alpha-synuclein, beta-amyloid, tau, and ubiquitin), total Fe staining, ferritin, hepcidin, tyrosine hydroxylase positive neurons, myelin and glial derived growth factors (glial cell markers) will be assessed in nigrostriatal structures in order to correlate these levels with MRI measures.
Biospecimen Retention: Samples With DNA
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): NCT01888185
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center and College of Medicine|
|Hershey, Pennsylvania, United States, 17033|