Identifying Biomarkers of Parkinson’s Disease Using Magnetic Resonance Imaging (MRI)

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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

, , 

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

, , 


Verification Date

January 2020