Trial Outcomes & Findings for Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and Controls (NCT NCT03675282)

Last Updated: 2025-03-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Baseline and 24 Months

Results posted on

2025-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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	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	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
Overall Study STARTED	20	27	2	9	24
Overall Study COMPLETED	15	17	1	7	17
Overall Study NOT COMPLETED	5	10	1	2	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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	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	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
Overall Study Lost to Follow-up	4	8	1	2	7
Overall Study received clinical care that was exclusionary to the study	0	2	0	0	0
Overall Study Physician Decision	1	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parkinson Disease - Stage 1 n=20 Participants 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	Parkinson Disease - Stage 2 n=27 Participants 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	Parkinson Disease - Stage 3 n=2 Participants 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	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	REM Sleep Behavior Disorder n=9 Participants 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	Healthy Controls n=24 Participants 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	Total n=82 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 7.9 • n=5 Participants	67.7 years STANDARD_DEVIATION 8.8 • n=7 Participants	75.0 years STANDARD_DEVIATION 2.8 • n=5 Participants	—	59.6 years STANDARD_DEVIATION 2.9 • n=21 Participants	61.5 years STANDARD_DEVIATION 8.6 • n=8 Participants	64.2 years STANDARD_DEVIATION 8.6 • n=8 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	—	1 Participants n=21 Participants	9 Participants n=8 Participants	24 Participants n=8 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	2 Participants n=5 Participants	—	8 Participants n=21 Participants	15 Participants n=8 Participants	58 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	2 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	16 Participants n=7 Participants	2 Participants n=5 Participants	—	5 Participants n=21 Participants	15 Participants n=8 Participants	51 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	—	2 Participants n=21 Participants	8 Participants n=8 Participants	27 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	16 Participants n=7 Participants	2 Participants n=5 Participants	—	7 Participants n=21 Participants	5 Participants n=8 Participants	41 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	—	2 Participants n=21 Participants	12 Participants n=8 Participants	34 Participants n=8 Participants
MOCA score	26.5 scores on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	25.6 scores on a scale STANDARD_DEVIATION 3.6 • n=7 Participants	29 scores on a scale STANDARD_DEVIATION 0 • n=5 Participants	—	27.4 scores on a scale STANDARD_DEVIATION 1.7 • n=21 Participants	26.3 scores on a scale STANDARD_DEVIATION 1.9 • n=8 Participants	26.3 scores on a scale STANDARD_DEVIATION 2.6 • n=8 Participants
UPDRS Scores UPDRS Part I	2.25 scores on a scale STANDARD_DEVIATION 1.83 • n=5 Participants	1.88 scores on a scale STANDARD_DEVIATION 1.67 • n=7 Participants	5 scores on a scale STANDARD_DEVIATION 0.0 • n=5 Participants	—	1.67 scores on a scale STANDARD_DEVIATION 1.50 • n=21 Participants	0.91 scores on a scale STANDARD_DEVIATION 2.57 • n=8 Participants	1.71 scores on a scale STANDARD_DEVIATION 2.06 • n=8 Participants
UPDRS Scores UPDRS Part II	6.11 scores on a scale STANDARD_DEVIATION 4.42 • n=5 Participants	7.28 scores on a scale STANDARD_DEVIATION 4.63 • n=7 Participants	13 scores on a scale STANDARD_DEVIATION 0 • n=5 Participants	—	0.56 scores on a scale STANDARD_DEVIATION 1.01 • n=21 Participants	0 scores on a scale STANDARD_DEVIATION 0 • n=8 Participants	4.10 scores on a scale STANDARD_DEVIATION 4.84 • n=8 Participants
UPDRS Scores UPDRS Part III	16.6 scores on a scale STANDARD_DEVIATION 6.3 • n=5 Participants	24.0 scores on a scale STANDARD_DEVIATION 10.3 • n=7 Participants	34 scores on a scale STANDARD_DEVIATION 0 • n=5 Participants	—	0.6 scores on a scale STANDARD_DEVIATION 1.1 • n=21 Participants	0 scores on a scale STANDARD_DEVIATION 0 • n=8 Participants	12.4 scores on a scale STANDARD_DEVIATION 12.7 • n=8 Participants
UPDRS Scores UPDRS Part IV	2.63 scores on a scale STANDARD_DEVIATION 1.89 • n=5 Participants	2.80 scores on a scale STANDARD_DEVIATION 3.33 • n=7 Participants	0 scores on a scale STANDARD_DEVIATION 0 • n=5 Participants	—	0.78 scores on a scale STANDARD_DEVIATION 0.83 • n=21 Participants	0.09 scores on a scale STANDARD_DEVIATION 0.29 • n=8 Participants	1.68 scores on a scale STANDARD_DEVIATION 2.45 • n=8 Participants
Sensitivity of QSM MR Imaging	379.5896 ppb STANDARD_DEVIATION 84.4375 • n=5 Participants	314.1832 ppb STANDARD_DEVIATION 138.1896 • n=7 Participants	561.1894 ppb STANDARD_DEVIATION 0.0 • n=5 Participants	—	288.1832 ppb STANDARD_DEVIATION 122.8809 • n=21 Participants	261.6498 ppb STANDARD_DEVIATION 72.7075 • n=8 Participants	314.6444 ppb STANDARD_DEVIATION 117.1813 • n=8 Participants
PE2i PET scan	3.47 Bmax/Kd STANDARD_DEVIATION 1.30 • n=5 Participants	3.10 Bmax/Kd STANDARD_DEVIATION 1.20 • n=7 Participants	2.33 Bmax/Kd STANDARD_DEVIATION 0.0 • n=5 Participants	—	3.87 Bmax/Kd STANDARD_DEVIATION 0.95 • n=21 Participants	3.58 Bmax/Kd STANDARD_DEVIATION 1.37 • n=8 Participants	3.39 Bmax/Kd STANDARD_DEVIATION 1.25 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline and 24 Months

Population: 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.

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

Outcome measures

Outcome measures
Measure	Parkinson Disease - Stage 1 n=15 Participants 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	Parkinson Disease - Stage 2 n=17 Participants 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	Parkinson Disease - Stage 3 n=1 Participants 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	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	REM Sleep Behavior Disorder n=7 Participants 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	Healthy Controls n=17 Participants 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
Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging Baseline	379.5896 ppb Standard Deviation 84.4375	314.1832 ppb Standard Deviation 138.1896	561.1894 ppb Standard Deviation 0	—	288.1832 ppb Standard Deviation 122.8809	261.6498 ppb Standard Deviation 72.7075
Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging 24 Months	359.7905 ppb Standard Deviation 152.2746	335.4785 ppb Standard Deviation 117.6937	0.0 ppb Standard Deviation 0.0	—	287.3132 ppb Standard Deviation 141.0688	250.1543 ppb Standard Deviation 80.9845

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Parkinson Disease - Stage 1 n=15 Participants 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	Parkinson Disease - Stage 2 n=17 Participants 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	Parkinson Disease - Stage 3 n=1 Participants 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	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	REM Sleep Behavior Disorder n=7 Participants 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	Healthy Controls n=17 Participants 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
Assess Clinical Changes in Disease Arm UPDRS Part II: 24 Months	7.563 score on a scale Standard Deviation 4.899	9.059 score on a scale Standard Deviation 6.722	31.0 score on a scale Standard Deviation 0.0	—	0.714 score on a scale Standard Deviation 0.756	0.529 score on a scale Standard Deviation 0.80
Assess Clinical Changes in Disease Arm UPDRS Part III: 24 Months	22.75 score on a scale Standard Deviation 9.248	27.588 score on a scale Standard Deviation 6.643	42.0 score on a scale Standard Deviation 0.0	—	1.429 score on a scale Standard Deviation 1.618	0.0 score on a scale Standard Deviation 0.0
Assess Clinical Changes in Disease Arm UPDRS Part IV: 24 Months	2.686 score on a scale Standard Deviation 1.922	3.176 score on a scale Standard Deviation 2.834	3.0 score on a scale Standard Deviation 0.0	—	0.857 score on a scale Standard Deviation 0.690	0.471 score on a scale Standard Deviation 0.624
Assess Clinical Changes in Disease Arm UPDRS Part I: Baseline	2.25 score on a scale Standard Deviation 1.83	1.88 score on a scale Standard Deviation 1.67	5 score on a scale Standard Deviation 0	—	1.67 score on a scale Standard Deviation 1.50	0.91 score on a scale Standard Deviation 2.57
Assess Clinical Changes in Disease Arm UPDRS Part II: Baseline	6.11 score on a scale Standard Deviation 4.42	7.28 score on a scale Standard Deviation 4.63	13 score on a scale Standard Deviation 0	—	0.56 score on a scale Standard Deviation 1.01	0 score on a scale Standard Deviation 0
Assess Clinical Changes in Disease Arm UPDRS Part III: Baseline	16.6 score on a scale Standard Deviation 6.3	24.0 score on a scale Standard Deviation 10.3	34 score on a scale Standard Deviation 0	—	0.6 score on a scale Standard Deviation 1.1	0 score on a scale Standard Deviation 0
Assess Clinical Changes in Disease Arm UPDRS Part IV: Baseline	2.63 score on a scale Standard Deviation 1.89	2.80 score on a scale Standard Deviation 3.33	0 score on a scale Standard Deviation 0	—	0.78 score on a scale Standard Deviation 0.83	0.09 score on a scale Standard Deviation 0.29
Assess Clinical Changes in Disease Arm UPDRS Part I: 24 Months	2.875 score on a scale Standard Deviation 2.156	2.294 score on a scale Standard Deviation 2.144	11.0 score on a scale Standard Deviation 0.0	—	2.857 score on a scale Standard Deviation 1.464	0.706 score on a scale Standard Deviation 1.404

SECONDARY outcome

Timeframe: Baseline and 24 Months

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