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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).
The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Early Imaging | Active Comparator | Group A will receive SPECT imaging 3 times during the study. The first scan will take place prior to the initiation of any treatment, followed by scans at week 26 and week 52. |
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| Group B - Delayed Imaging | Active Comparator | Group B will receive SPECT imaging 2 times during the study. Group B will not have the first scan (prior to the initiation of any treatment). Scan will take place at week 26 and week 52. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A - Early Imaging | Radiation | Total of 3 scans |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient adherence to treatment plan | Patient and treating physician agree on a treatment plan at visit 3. Patient adherence to medications will be evaluated based on pill count at each follow-up study visit. Additionally, each patient will record their adherence to therapy on the Patient Expectations and Disease-related Questionnaire (PEDQ) at each follow-up study visit, allowing the study team to track compliance with pharmacologic therapy as well as treatments including therapy exercise plans. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson Disease Rating Scale (UPDRS) | Other outcome measures will be between any group differences in UPDRS. | 1 year |
| Life Orientation Test - Revised (LOT-R) | Other outcome measures will be between any group differences in LOT-R. This test assesses individual differences in generalized optimism versus pessimism. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Hickey, DO | Duke University Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Group B - Delayed Imaging | Radiation | Total of 2 scans |
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| 1 year |
| Marlowe - Crowne Social Desirability Scale (MCSD) | Other outcome measures will be between any group differences in MCSD. This test assesses the extent to which individuals attempt to depict themselves as similar to the norms and standards of their society and community. | 1 year |
| Obsessive - Compulsive Inventory (OCI) | Other outcome measures will be between any group differences in OCI. This self-report scale assesses distress from symptoms commonly experienced in obsessive-compulsive disorder. | 1 year |
| Expectation of Global Response (EGCR) | Other outcome measures will be between any group differences in EGCR. | 1 year |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |