Healthy, Parkinson Disease, REM Sleep Behavior Disorder
Conditions
Keywords
MRI, PET Scan
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.
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.
Interventions
DRUG(11C)PE2I
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
DRUGIoflupane
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
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess Clinical Changes in Disease Arm | 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. |
| Assess Change in PE2i PET Scan or DaT Scan | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 27 |
| 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 | 2 |
| 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 | 0 |
| 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 | 9 |
| 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 | 24 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 8 | 1 | 0 | 2 | 7 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | received clinical care that was exclusionary to the study | 0 | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Parkinson Disease - Stage 2 | Parkinson Disease - Stage 3 | Parkinson Disease - Stage 1 | REM Sleep Behavior Disorder | Healthy Controls | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 8.8 | 75.0 years STANDARD_DEVIATION 2.8 | 62.6 years STANDARD_DEVIATION 7.9 | 59.6 years STANDARD_DEVIATION 2.9 | 61.5 years STANDARD_DEVIATION 8.6 | 64.2 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 2 Participants | 13 Participants | 5 Participants | 15 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 0 Participants | 6 Participants | 2 Participants | 8 Participants | 27 Participants |
| MOCA score | 25.6 scores on a scale STANDARD_DEVIATION 3.6 | 29 scores on a scale STANDARD_DEVIATION 0 | 26.5 scores on a scale STANDARD_DEVIATION 2.1 | 27.4 scores on a scale STANDARD_DEVIATION 1.7 | 26.3 scores on a scale STANDARD_DEVIATION 1.9 | 26.3 scores on a scale STANDARD_DEVIATION 2.6 |
| PE2i PET scan | 3.10 Bmax/Kd STANDARD_DEVIATION 1.2 | 2.33 Bmax/Kd STANDARD_DEVIATION 0 | 3.47 Bmax/Kd STANDARD_DEVIATION 1.3 | 3.87 Bmax/Kd STANDARD_DEVIATION 0.95 | 3.58 Bmax/Kd STANDARD_DEVIATION 1.37 | 3.39 Bmax/Kd STANDARD_DEVIATION 1.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 0 Participants | 9 Participants | 2 Participants | 12 Participants | 34 Participants |
| Race (NIH/OMB) White | 16 Participants | 2 Participants | 11 Participants | 7 Participants | 5 Participants | 41 Participants |
| Sensitivity of QSM MR Imaging | 314.1832 ppb STANDARD_DEVIATION 138.1896 | 561.1894 ppb STANDARD_DEVIATION 0 | 379.5896 ppb STANDARD_DEVIATION 84.4375 | 288.1832 ppb STANDARD_DEVIATION 122.8809 | 261.6498 ppb STANDARD_DEVIATION 72.7075 | 314.6444 ppb STANDARD_DEVIATION 117.1813 |
| Sex: Female, Male Female | 8 Participants | 0 Participants | 6 Participants | 1 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Male | 19 Participants | 2 Participants | 14 Participants | 8 Participants | 15 Participants | 58 Participants |
| UPDRS Scores UPDRS Part I | 1.88 scores on a scale STANDARD_DEVIATION 1.67 | 5 scores on a scale STANDARD_DEVIATION 0 | 2.25 scores on a scale STANDARD_DEVIATION 1.83 | 1.67 scores on a scale STANDARD_DEVIATION 1.5 | 0.91 scores on a scale STANDARD_DEVIATION 2.57 | 1.71 scores on a scale STANDARD_DEVIATION 2.06 |
| UPDRS Scores UPDRS Part II | 7.28 scores on a scale STANDARD_DEVIATION 4.63 | 13 scores on a scale STANDARD_DEVIATION 0 | 6.11 scores on a scale STANDARD_DEVIATION 4.42 | 0.56 scores on a scale STANDARD_DEVIATION 1.01 | 0 scores on a scale STANDARD_DEVIATION 0 | 4.10 scores on a scale STANDARD_DEVIATION 4.84 |
| UPDRS Scores UPDRS Part III | 24.0 scores on a scale STANDARD_DEVIATION 10.3 | 34 scores on a scale STANDARD_DEVIATION 0 | 16.6 scores on a scale STANDARD_DEVIATION 6.3 | 0.6 scores on a scale STANDARD_DEVIATION 1.1 | 0 scores on a scale STANDARD_DEVIATION 0 | 12.4 scores on a scale STANDARD_DEVIATION 12.7 |
| UPDRS Scores UPDRS Part IV | 2.80 scores on a scale STANDARD_DEVIATION 3.33 | 0 scores on a scale STANDARD_DEVIATION 0 | 2.63 scores on a scale STANDARD_DEVIATION 1.89 | 0.78 scores on a scale STANDARD_DEVIATION 0.83 | 0.09 scores on a scale STANDARD_DEVIATION 0.29 | 1.68 scores on a scale STANDARD_DEVIATION 2.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 27 | 0 / 2 | 0 / 0 | 0 / 9 | 0 / 24 |
| other Total, other adverse events | 0 / 20 | 0 / 27 | 0 / 2 | 0 / 0 | 0 / 9 | 0 / 24 |
| serious Total, serious adverse events | 0 / 20 | 0 / 27 | 0 / 2 | 0 / 0 | 0 / 9 | 0 / 24 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parkinson Disease - Stage 1 | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | Baseline | 379.5896 ppb | Standard Deviation 84.4375 |
| Parkinson Disease - Stage 1 | 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 |
| Parkinson Disease - Stage 2 | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | Baseline | 314.1832 ppb | Standard Deviation 138.1896 |
| Parkinson Disease - Stage 2 | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | 24 Months | 335.4785 ppb | Standard Deviation 117.6937 |
| Parkinson Disease - Stage 3 | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | Baseline | 561.1894 ppb | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | 24 Months | 0.0 ppb | Standard Deviation 0 |
| REM Sleep Behavior Disorder | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | 24 Months | 287.3132 ppb | Standard Deviation 141.0688 |
| REM Sleep Behavior Disorder | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | Baseline | 288.1832 ppb | Standard Deviation 122.8809 |
| Healthy Controls | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | Baseline | 261.6498 ppb | Standard Deviation 72.7075 |
| Healthy Controls | Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging | 24 Months | 250.1543 ppb | Standard Deviation 80.9845 |
Comparison: Parkinson Disease - Stage 1 (Baseline vs. 24 months)p-value: 0.66paired t-test
Comparison: Parkinson Disease - Stage 2 (Baseline vs. 24 months)p-value: 0.63paired t-test
Comparison: REM Sleep Behavior Disorder (Baseline vs. 24 months)p-value: 0.99paired t-test
Comparison: Healthy Controls (Baseline vs. 24 months)p-value: 0.67paired t-test
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
Time frame: 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. 0 subjects were analyzed for the PD Stage 4 arm because no Stage 4 patients were enrolled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parkinson Disease - Stage 1 | Assess Change in PE2i PET Scan or DaT Scan | Baseline | 3.47 Bmax/Kd | Standard Deviation 1.3 |
| Parkinson Disease - Stage 1 | Assess Change in PE2i PET Scan or DaT Scan | 24 Months | 3.07 Bmax/Kd | Standard Deviation 0.65 |
| Parkinson Disease - Stage 2 | Assess Change in PE2i PET Scan or DaT Scan | Baseline | 3.10 Bmax/Kd | Standard Deviation 1.2 |
| Parkinson Disease - Stage 2 | Assess Change in PE2i PET Scan or DaT Scan | 24 Months | 3.07 Bmax/Kd | Standard Deviation 1.17 |
| Parkinson Disease - Stage 3 | Assess Change in PE2i PET Scan or DaT Scan | Baseline | 2.33 Bmax/Kd | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Change in PE2i PET Scan or DaT Scan | 24 Months | 2.38 Bmax/Kd | Standard Deviation 0 |
| REM Sleep Behavior Disorder | Assess Change in PE2i PET Scan or DaT Scan | 24 Months | 3.37 Bmax/Kd | Standard Deviation 1.41 |
| REM Sleep Behavior Disorder | Assess Change in PE2i PET Scan or DaT Scan | Baseline | 3.87 Bmax/Kd | Standard Deviation 0.95 |
| Healthy Controls | Assess Change in PE2i PET Scan or DaT Scan | Baseline | 3.58 Bmax/Kd | Standard Deviation 1.37 |
| Healthy Controls | Assess Change in PE2i PET Scan or DaT Scan | 24 Months | 3.48 Bmax/Kd | Standard Deviation 0.8 |
Comparison: Parkinson Disease - Stage 1 (Baseline vs. 24 months)p-value: 0.3paired t-test
Comparison: Parkinson Disease - Stage 2 (Baseline vs. 24 months)p-value: 0.94paired t-test
Comparison: REM Sleep Behavior Disorder (Baseline vs. 24 months)p-value: 0.45paired t-test
Comparison: Healthy Controls (Baseline vs. 24 months)p-value: 0.8paired t-test
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.
Time frame: 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. 0 subjects were analyzed for the PD Stage 4 arm because no Stage 4 patients were enrolled
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part I: Baseline | 2.25 score on a scale | Standard Deviation 1.83 |
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part II: Baseline | 6.11 score on a scale | Standard Deviation 4.42 |
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part III: Baseline | 16.6 score on a scale | Standard Deviation 6.3 |
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part IV: Baseline | 2.63 score on a scale | Standard Deviation 1.89 |
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part I: 24 Months | 2.875 score on a scale | Standard Deviation 2.156 |
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part II: 24 Months | 7.563 score on a scale | Standard Deviation 4.899 |
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part III: 24 Months | 22.75 score on a scale | Standard Deviation 9.248 |
| Parkinson Disease - Stage 1 | Assess Clinical Changes in Disease Arm | UPDRS Part IV: 24 Months | 2.686 score on a scale | Standard Deviation 1.922 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part III: Baseline | 24.0 score on a scale | Standard Deviation 10.3 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part II: 24 Months | 9.059 score on a scale | Standard Deviation 6.722 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part I: Baseline | 1.88 score on a scale | Standard Deviation 1.67 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part IV: Baseline | 2.80 score on a scale | Standard Deviation 3.33 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part II: Baseline | 7.28 score on a scale | Standard Deviation 4.63 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part IV: 24 Months | 3.176 score on a scale | Standard Deviation 2.834 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part I: 24 Months | 2.294 score on a scale | Standard Deviation 2.144 |
| Parkinson Disease - Stage 2 | Assess Clinical Changes in Disease Arm | UPDRS Part III: 24 Months | 27.588 score on a scale | Standard Deviation 6.643 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part III: 24 Months | 42.0 score on a scale | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part IV: 24 Months | 3.0 score on a scale | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part IV: Baseline | 0 score on a scale | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part II: 24 Months | 31.0 score on a scale | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part III: Baseline | 34 score on a scale | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part II: Baseline | 13 score on a scale | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part I: Baseline | 5 score on a scale | Standard Deviation 0 |
| Parkinson Disease - Stage 3 | Assess Clinical Changes in Disease Arm | UPDRS Part I: 24 Months | 11.0 score on a scale | Standard Deviation 0 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part II: Baseline | 0.56 score on a scale | Standard Deviation 1.01 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part III: Baseline | 0.6 score on a scale | Standard Deviation 1.1 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part IV: Baseline | 0.78 score on a scale | Standard Deviation 0.83 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part I: 24 Months | 2.857 score on a scale | Standard Deviation 1.464 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part II: 24 Months | 0.714 score on a scale | Standard Deviation 0.756 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part IV: 24 Months | 0.857 score on a scale | Standard Deviation 0.69 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part I: Baseline | 1.67 score on a scale | Standard Deviation 1.5 |
| REM Sleep Behavior Disorder | Assess Clinical Changes in Disease Arm | UPDRS Part III: 24 Months | 1.429 score on a scale | Standard Deviation 1.618 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part IV: Baseline | 0.09 score on a scale | Standard Deviation 0.29 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part IV: 24 Months | 0.471 score on a scale | Standard Deviation 0.624 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part III: Baseline | 0 score on a scale | Standard Deviation 0 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part III: 24 Months | 0.0 score on a scale | Standard Deviation 0 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part I: Baseline | 0.91 score on a scale | Standard Deviation 2.57 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part II: 24 Months | 0.529 score on a scale | Standard Deviation 0.8 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part II: Baseline | 0 score on a scale | Standard Deviation 0 |
| Healthy Controls | Assess Clinical Changes in Disease Arm | UPDRS Part I: 24 Months | 0.706 score on a scale | Standard Deviation 1.404 |
Comparison: Parkinson Disease - Stage 1 UPDRS Part I (Baseline vs. 24 months)p-value: 0.4paired t-test
Comparison: Parkinson Disease - Stage 1 UPDRS Part II (Baseline vs. 24 months)p-value: 0.4paired t-test
p-value: 0.04paired t-test
Comparison: Parkinson Disease - Stage 1 UPDRS Part IV (Baseline vs. 24 months)p-value: 0.94paired t-test
Comparison: Parkinson Disease - Stage 2 UPDRS Part I (Baseline vs. 24 months)p-value: 0.53paired t-test
Comparison: Parkinson Disease - Stage 2 UPDRS Part II (Baseline vs. 24 months)p-value: 0.38paired t-test
Comparison: Parkinson Disease - Stage 2 UPDRS Part III (Baseline vs. 24 months)p-value: 0.24paired t-test
Comparison: Parkinson Disease - Stage 2 UPDRS Part IV (Baseline vs. 24 months)p-value: 0.73paired t-test
Comparison: REM Sleep Behavior Disorder UPDRS Part I (Baseline vs. 24 months)p-value: 0.16paired t-test
Comparison: REM Sleep Behavior Disorder UPDRS Part II (Baseline vs. 24 months)p-value: 0.75paired t-test
Comparison: REM Sleep Behavior Disorder UPDRS Part III (Baseline vs. 24 months)p-value: 0.28paired t-test
Comparison: REM Sleep Behavior Disorder UPDRS Part IV (Baseline vs. 24 months)p-value: 0.85paired t-test
Comparison: Healthy Controls UPDRS Part I (Baseline vs. 24 months)p-value: 0.78paired t-test
Comparison: Healthy Controls UPDRS Part IV (Baseline vs. 24 months)p-value: 0.03paired t-test