Parkinson's Disease Clinical Trial
Official title:
Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
The primary objective of this protocol is to investigate the monoaminergic
(dopamine、serotonin、and norepinephrine ) nervous system and amyloid deposition in
Parkinson's disease patients with non-motor symptoms (focus on impulse control disorders and
dementia) by novel 18F-DTBZ and Florbetapir F-18 PET imaging.
This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and
monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group.
Investigators will also analyze monoaminergic function by18F- DTBZ PET in PDI group.
Study duration is expected to be completed in a period of 3 year. This study will compare
the amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function
by18F- DTBZ PET in 10 age-matched healthy subjects (NC group), 30 PD patients without
dementia/ICD (PD group), 30 PD patients with dementia (PDD group), and 20 patients with
dementia (AD group). We will also analyze monoaminergic function by18F- DTBZ PET in 30 PD
patients with ICD (PDI group).
Each evaluable subject involved in this study must fulfill all the inclusion and exclusion
criteria according the subject grouping, healthy subjects, PD, PDD, and AD patients will
have 4 visits in this study ,as one screening visit, one florbetapir F-18 imaging visit, one
18F-DTBZ imaging visit, and one safety evaluation.PDI patients will have 3 visits in this
study, as one screening visit, one 18F-DTBZ imaging visit, and one safety evaluation. Safety
measurement will be evaluated by medical history, vital signs, physical examinations,
laboratory examinations and collecting of adverse events.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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