Brief Title
Identifying Biomarkers of Parkinson's Disease Using Magnetic Resonance Imaging (MRI)
Official Title
Multimodal MRI Markers of Nigrostriatal Pathology in Parkinson's Disease
Brief Summary
This study is designed to determine if magnetic resonance imaging (MRI) measures can be used
to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing
between PD and parkinsonisms [conditions that are PD look-a-like diseases such as progressive
supranuclear palsy (PSP) or multiple system atrophy (MSA)] when combined with changes in
certain proteins in body fluids that are related to iron (Fe).
Detailed Description
The lack of in vivo biomarker(s) reflecting Parkinson's disease (PD)-related cell loss and
associated pathoetiological/physiological processes in nigrostriatal structures has hindered
discovery research and limited the ability to evaluate disease-modifying therapies. Recent
research has generated excitement for using DTI and R2* MRI measures as biomarker(s) for
PD-related pathology in nigrostriatal pathways, but they fall short by the lack of
understanding of their clinical implications and biological/pathological underpinnings.
Working closely with the National Institute of Neurological Disorders and Stroke (NINDS)
Parkinson's Disease Biomarkers Program (PDBP), the proposed work will investigate multimodal
MRI techniques in combination with fluid-based iron (Fe) protein profiles to serve as in vivo
markers for PD-related nigrostriatal pathology that can be used as biomarkers for diagnosing
PD, following its progression, and gaining mechanistic understanding of PD pathoetiology and
pathophysiology.
Study Type
Observational
Primary Outcome
Differential roles of fractional anisotropy (FA) and R2* in PD detection and progression
Secondary Outcome
Nigrostriatal diffusion tensor imaging (DTI) and R2* differentiate PD from parkinsonian syndromes
Condition
Parkinson's Disease (PD)
Study Arms / Comparison Groups
Parkinson's Disease (PD)
Description: Patients with a clinical diagnosis of PD (in various stages)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
290
Start Date
December 2012
Completion Date
December 31, 2019
Primary Completion Date
December 2019
Eligibility Criteria
Inclusion Criteria:
PD Subjects:
1. Able and willing to sign the consent form at time of initial enrollment or if the
subject is decisionally impaired and has a legal representative that is able and
willing to sign a consent form at the time of the enrollment. If the subject becomes
decisionally impaired during the course of the study, their legal representative may
sign an addendum to consent for continued participation.
2. MMSE score of 15 or greater unless a legal representative is present.
3. Idiopathic PD according to published criteria.
4. History of adequate response to dopaminergic therapy.
5. History of asymmetrical symptom onset
MSA Subjects:
1. Older than 30 yrs.
2. Able and willing to sign the consent form at time of initial enrollment or if the
subject is decisionally impaired and has a legal representative that is able and
willing to sign a consent form at the time of the enrollment. If the subject becomes
decisionally impaired during the course of the study, their legal representative may
sign an addendum to consent for continued participation.
3. MMSE score of 15 or greater unless a legal representative is present.
4. MSA according to published criteria.
5. History of autonomic & urinary dysfunction and/or severe cerebellar ataxia.
PSP Subjects:
1. Older than 40 yrs.
2. Able and willing to sign the consent form at time of initial enrollment or if the
subject is decisionally impaired and has a legal representative that is able and
willing to sign a consent form at the time of the enrollment. If the subject becomes
decisionally impaired during the course of the study, their legal representative may
sign an addendum to consent for continued participation.
3. PSP according to published criteria.
4. Vertical gaze palsy and/or slow vertical gaze/postural instability during first year
of diagnosis.
5. MMSE score of 15 or greater unless a legal representative is present
Controls:
1. Older than 21 yrs.
2. Able and willing to sign the consent form.
3. MMSE greater than 24.
Exclusion Criteria:
PD Subjects:
1. Unable or does not have a legal representative/unwilling to provide consent.
2. Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe
scoliosis, etc.).
3. History of cerebrovascular diseases or other neurological disorders.
4. Major medical problems such as renal or liver failure.
5. Unstable, non-PD-related medical conditions.
6. MMSE score less than 15 unless a legal representative is present
7. Use of anticoagulant medications.
8. Signs of dementia.
MSA Subjects:
1. Unable or does not have a legal representative /unwilling to provide consent.
2. Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe
scoliosis, etc.).
3. History of cerebrovascular diseases or other neurological disorders.
4. Major medical problems such as renal or liver failure.
5. Unstable, non-MSA-related medical conditions.
6. MMSE score less than 15 unless a legal representative is present
7. Use of anticoagulant medications.
8. Signs of dementia.
PSP Subjects:
1. Unable or does not have a legal representative /unwilling to provide consent.
2. Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe
scoliosis, etc.).
3. History of cerebrovascular diseases or other neurological disorders.
4. Major medical problems such as renal or liver failure.
5. Unstable, non-PSP-related medical conditions.
6. MMSE score less than 15 unless a legal representative is present
7. Use of anticoagulant medications.
8. Signs of dementia.
Controls:
1. Unable/unwilling to provide consent.
2. Evidence of severe memory impairment or signs of dementia (MMSE < 24).
3. Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe
scoliosis, etc.).
4. History of cerebrovascular diseases or other neurological disorders.
5. Major medical problems such as renal or liver failure.
6. Unstable medical conditions.
7. Use of anticoagulant medications.
8. Signs of dementia.
Gender
All
Ages
21 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01888185
Organization ID
MSHersheyMC-40726
Responsible Party
Principal Investigator
Study Sponsor
Milton S. Hershey Medical Center
Study Sponsor
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Verification Date
January 2020