Chang Gung Memory Hospital
Taoyuan, 333, Taiwan
NCT Number: NCT02599753
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.
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Notify Me20 year–80 year
All sexes
Interventional
Phase 2
Taoyuan, 333, Taiwan
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 4 years
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.
Time frame: 4 years
Time frame: 4 years
Chang Gung Memorial Hospital
Other
Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients With Neuropsychiatric Disorders by Multimodal Neuroimaging
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