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The objective of this protocol is to investigate the microstructural alterations and monoaminergic function in Parkinson's disease patients with impulse control disorders and cognitive impairment by multimodal MRI and 18F-DTBZ PET imaging.
Study duration is expected to be completed in a period of 4 year. This study will compare the microstructural integrity by multimodal MRI imaging and monoaminergic function by18F- DTBZ PET in 35 PD patients without dementia/ICD (PD group), 35 patients with mild cognitive impairment (PD-MCI), 35 PD patients with dementia (PDD group), and 35 patients with impulse control disorders (PD-ICD group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DTBZ for Parkinson's Disease | Experimental | The participants qualify for the study will return to the clinic at a later date and will have catheter(s) placed for i.v. administration of 18F- DTBZ for injection. The participants will receive a single i.v. bolus of 18F- DTBZ, followed by brain PET imaging of 10 minutes duration, approximately 80 minutes post-dose injection. Vital signs will be obtained prior to and immediately after the administration of 18F- DTBZ, and at the completion of the imaging session. Adverse events will be continuously monitored during the imaging session. The participants experience any adverse event will not be discharged until the event has resolved or stabilized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18-FDTBZ | Drug | During this study, participants will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV. The proposed dose for this study is based on the investigators' phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG (Lin 2010). |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of specific uptake ratio (SUR) of 18F- DTBZ between each diagnostic group | The SUVRs of 18F-FP-(+)-DTBZ in ipsilateral caudate, anterior putamen, and bilateral nucleus accumbans were significantly lower in PDD group than those of PD group. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of eigenvalues obtained from diffusion tensor imaging (DTI) between each diagnostic group. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation between SURs of 18F-DTBZ and eigenvalues of DTI in each brain regions and the severity of motor or nonmotor symptoms. | 4 years |
Inclusion Criteria:
PD group: 35 subjects with a diagnosis of PD whom must:
PD-MCI group: 35 subjects with a diagnosis of PD with mild cognitive impairment whom must:
PDD group: 35 subjects with a diagnosis of PD with dementia whom must:
PD-ICD group: 35 subjects with a diagnosis of PD with ICD whom must:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memory Hospital | Taoyuan | 333 | Taiwan |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |