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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS095562-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson Disease - Stage 1 | Experimental | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months |
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| Parkinson Disease - Stage 2 | Experimental | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months |
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| Parkinson Disease - Stage 3 | Experimental | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months |
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| Parkinson Disease - Stage 4 | Experimental | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months |
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| REM Sleep Behavior Disorder | Experimental | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (11C)PE2I | Drug | Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | 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 | Baseline and 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Clinical Changes in Disease Arm | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Shtilbans, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parkinson Disease - Stage 1 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2021 |
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| Healthy Controls | Experimental | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months |
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| Ioflupane | Drug | Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
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| Baseline and 24 Months |
| Assess Change in PE2i PET Scan or DaT Scan | Assess changes in dopamine depletion as measured by the baseline PE2i PET scan or DaT scan compared to the 24 month PE2i PET scan or DaT scan | Baseline and 24 Months |
| FG001 | Parkinson Disease - Stage 2 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| FG002 | Parkinson Disease - Stage 3 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| FG003 | Parkinson Disease - Stage 4 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| FG004 | REM Sleep Behavior Disorder | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| FG005 | Healthy Controls | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
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| NOT COMPLETED |
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0 subjects were analyzed in the PD Stage 4 arm because no Stage 4 patients were enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Parkinson Disease - Stage 1 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| BG001 | Parkinson Disease - Stage 2 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| BG002 | Parkinson Disease - Stage 3 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| BG003 | Parkinson Disease - Stage 4 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| BG004 | REM Sleep Behavior Disorder | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| BG005 | Healthy Controls | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| MOCA score | The Montreal Cognitive Assessment (MOCA) is a brief test that screens for cognitive impairment and dementia. The lowest score is 0 and the highest score is 30. A score of 26 or higher is generally considered normal, while lower scores indicate cognitive impairment. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| UPDRS Scores | The Unified Parkinson's Disease Rating Scale (UPDRS) is a tool used to measure the severity and progression of Parkinson's disease. Part I: evaluation of mentation, behavior, and mood (0-16) 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 (0-52) Part III: clinician-scored monitored motor evaluation (0-108) Part IV: complications of therapy (0-23) The higher the score value, the worse symptoms are. | Mean | Standard Deviation | scores on a scale |
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| Sensitivity of QSM MR Imaging | Mean | Standard Deviation | ppb |
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| PE2i PET scan | Mean | Standard Deviation | Bmax/Kd |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | 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 | This analysis population included Parkinson's disease patients, stages I-III, REM Sleep behavior disorder patients, and healthy controls who completed the study. One Stage III Parkinson's disease patient was excluded because their MRI protocol did not include T1, and we were therefore unable to get QSM values. 0 subjects were analyzed for the PD Stage 4 arm because no Stage 4 patients were enrolled. | Posted | Mean | Standard Deviation | ppb | Baseline and 24 Months |
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| Secondary | Assess Clinical Changes in Disease Arm | 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. | This analysis population included Parkinson's disease patients, stages I-III, REM Sleep behavior disorder patients, and healthy controls who completed the study. 0 subjects were analyzed for the PD Stage 4 arm because no Stage 4 patients were enrolled | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 Months |
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| Secondary | Assess Change in PE2i PET Scan or DaT Scan | Assess changes in dopamine depletion as measured by the baseline PE2i PET scan or DaT scan compared to the 24 month PE2i PET scan or DaT scan | This analysis population included Parkinson's disease patients, stages I-III, REM Sleep behavior disorder patients, and healthy controls who completed the study. 0 subjects were analyzed for the PD Stage 4 arm because no Stage 4 patients were enrolled. | Posted | Mean | Standard Deviation | Bmax/Kd | Baseline and 24 Months |
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Adverse event data were collected over the course of the study per participant which was 2 years ± 2 months.
The number of participants in Parkinson's disease Stage 4 arm for serious adverse events, all cause mortality, and other adverse events are all zero because we did not recruit any PD stage 4 patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parkinson's Disease Stage 1 | PD stage 1 | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Parkinson's Disease Stage 2 | PD stage 2 | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Parkinson's Disease Stage 3 | PD stage 3 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Parkinson's Disease Stage 4 | PD stage 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | REM Sleep Behavior Disorder | RBD | 0 | 9 | 0 | 9 | 0 | 9 |
| EG005 | Healthy Controls | Healthy controls | 0 | 24 | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carly Skudin; Research Program Manager | Weill Cornell Medicine | 212-746-2003 | cas4010@med.cornell.edu |
| Jan 14, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2021 | Dec 13, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C113010 | N-(3-iodoprop-2-enyl)-2-beta-carbomethoxy-3-(4-methylphenyl)nortropane |
| D009682 | Magnetic Resonance Spectroscopy |
| C519528 | ioflupane |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| UPDRS Part II |
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| UPDRS Part III |
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| UPDRS Part IV |
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| 24 Months |
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| 0.63 |
| Mean Difference (Final Values) |
| -21.3 |
| 2-Sided |
| Superiority |
| REM Sleep Behavior Disorder (Baseline vs. 24 months) | paired t-test | 0.99 | Mean Difference (Final Values) | 0.87 | 2-Sided | Superiority |
| Healthy Controls (Baseline vs. 24 months) | paired t-test | 0.67 | Mean Difference (Final Values) | 11.5 | 2-Sided | Superiority |
| Parkinson Disease - Stage 2 |
MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| OG002 | Parkinson Disease - Stage 3 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| OG003 | Parkinson Disease - Stage 4 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| OG004 | REM Sleep Behavior Disorder | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| OG005 | Healthy Controls | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
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| Parkinson Disease - Stage 3 |
MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| OG003 | Parkinson Disease - Stage 4 | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| OG004 | REM Sleep Behavior Disorder | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
| OG005 | Healthy Controls | MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months (11C)PE2I: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits Ioflupane: Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits |
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