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Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and Controls

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ClinicalTrials.gov Identifier: NCT03675282
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
Prospective, single center study to determine whether the current R2* iron mapping method for measuring nigral iron changes in the brain can be significantly improved by using the Quantitative Susceptibility Mapping (QSM) based iron mapping techniques with the goal of validating QSM for potential use in later clinical trials. Subjects with a diagnosis of Parkinson's Disease, Rapid Eye Movement (REM) Sleep Behavior Disorder, and Normal Volunteers who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Condition or disease Intervention/treatment Phase
Parkinson Disease REM Sleep Behavior Disorder Healthy Drug: (11C)PE2I Phase 1 Phase 2

Detailed Description:
This study will evaluate the rate of iron accumulation throughout different stages of the disease and compare it to controls Thus, the investigators will be able to see if iron starts to accumulate in those patients, way before motor symptoms of Parkinson disease develop. Hypothetically, an iron chelator drug could remove excessive iron from the brain and slow down process of neurodegeneration. A precise technique to measure iron in the brain and to detect small changes therefore is needed as a radiological marker of disease progression and/or therapeutic effect in clinical trials.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and Controls
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson Disease - Stage 1
MRI Brain at Baseline and 24 Months PE2i PET Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Drug: (11C)PE2I
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
Other Name: PET Scan

Experimental: Parkinson Disease - Stage 2
MRI Brain at Baseline and 24 Months PE2i PET Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Drug: (11C)PE2I
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
Other Name: PET Scan

Experimental: Parkinson Disease - Stage 3
MRI Brain at Baseline and 24 Months PE2i PET Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Drug: (11C)PE2I
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
Other Name: PET Scan

Experimental: Parkinson Disease - Stage 4
MRI Brain at Baseline and 24 Months PE2i PET Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Drug: (11C)PE2I
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
Other Name: PET Scan

Experimental: REM Sleep Behavior Disorder
MRI Brain at Baseline and 24 Months PE2i PET Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Drug: (11C)PE2I
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
Other Name: PET Scan

Experimental: Healthy Controls
MRI Brain at Baseline and 24 Months PE2i PET Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Drug: (11C)PE2I
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
Other Name: PET Scan




Primary Outcome Measures :
  1. Change in Sensitivity of QSM MR imaging from baseline MR imaging to 24 month MR imaging [ Time Frame: Baseline and 24 Months ]
    Change in Sensitivity of QSM MR imaging as compared to R2* from baseline MR imaging to 24 month MR imaging, as measured by Radiology reader agreements


Secondary Outcome Measures :
  1. Assess clinical changes in disease arm [ Time Frame: Baseline and 24 Months ]

    Assess clinical changes in disease arm, as measured by changes in unified Parkinson's disease rating scale (UPDRS) scale assessments at baseline and 24 Month visits. The UPDRS is used to follow the longitudinal course of Parkinson's disease.

    The UPDRS is made up of 42 questions grouped into 4 sections:

    Part I: evaluation of mentation, behavior, and mood Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Part IV: complications of therapy

    score for part I range is: 0-16 score for part II range is:0- 52 score for part III range is: 0-108 score for part IV range is: 0-23

    The higher the score value, the worse symptoms are.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Idiopathic Parkinson's Disease, REM Sleep Behavior Disorder subjects without signs of Parkinsonism and normal healthy controls a. If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms. b. For PD Subjects only: Age > 30 years at time of diagnosis of PD with a maximum age of 100 years old c. Hoehn & Yahr stage < V (if PD)
  • 2. For PD subjects only: Receiving an optimized dopaminergic regimen (i.e., either MAO-B inhibitor, a dopamine agonist and/or low doses of L-dopa, with dose change no more frequent than every 6-month in the course of the study); or medications naive
  • 3. No overt anemia, iron deficiency, or other hematological disorders
  • 4. Deemed healthy and able to undergo MRI and PE2i PET imaging by the Site Investigator, based on screening assessments-- medical history, physical examination 5. For Controls & REM Sleep Behavior Disorder Subjects Only: Age 20-80; willing to undergo multiple imaging sessions 6. Signed informed consent form

Exclusion Criteria:

  • 1. Patient with atypical parkinsonism (such as suspected Progressive Supranuclear Palsy, Multiple System Atrophy) and secondary parkinsonism (such as normal pressure hydrocephalus, drug-induced, or vascular parkinsonism)
  • 2. Patients with uncertainty as to having classical Parkinson's disease, such as those who might have scans without evidence of dopaminergic deficits (SWEDDs)
  • 3. Presence of a medical or psychiatric comorbidity that can compromise participation in the study
  • 4. Patients with clinically significant depression as determined by the Beck depression score > 15
  • 5. History of exposure to typical or atypical neuroleptics or any dopamine blocking agent within 6 months prior to enrollment
  • 6. Patients with psychosis/active hallucinations and memory difficulty pre-dating the onset of motor symptoms
  • 7. History of brain surgery for PD
  • 8. History of thyroid disease
  • 9. History of stroke or cerebral vascular disease
  • 10. History of drug abuse
  • 11. History of repeated head injury or encephalitis
  • 12. Positive dementia by DSM IV-R
  • 13. Women of childbearing potential who are not surgically sterilized have to use a reliable measure of contraception and have a negative urine pregnancy test at the screening
  • 14. Participation in other investigational drug trials within 30 days prior to screening
  • 15. Contraindication for receiving MRI imaging such as presence of pacemakers, certain types of metallic implants, severe claustrophobia, history of reaction to contrast material, or renal insufficiency

Information from the National Library of Medicine

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): NCT03675282


Contacts
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Contact: Eileen Chang (212) 746-6248 eic2002@med.cornell.edu
Contact: Jamie Stern (212) 746-9748

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Eileen Chang    212-746-6248    eic2002@med.cornell.edu   
Contact: Jamie Stern    (212) 746-9748      
Principal Investigator: Alexander Shtilbans, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Alexander Shtilbans, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03675282     History of Changes
Other Study ID Numbers: 1711018740
1R01NS095562-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
MRI
PET Scan

Additional relevant MeSH terms:
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Parkinson Disease
Mental Disorders
REM Sleep Behavior Disorder
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders