Parkinson's Disease Clinical Trial
Official title:
From Mouse Models to Patients: Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism
The primary objective of this protocol is to access the utility of 18F-DTBZ PET imaging as an in vivo biomarker to monitor neurodegeneration of both PD mouse models and PD patients. Secondary, the investigators will analyze progression rate of genetic-proving PARK8 and PARK6 patients who have homogeneous phenotype and genotype by 18F-DTBZ PET imaging.
Total of 60 patients, 20 LRRK2 G2385R, 20 PARK6, and 20 idiopathic PD, will be recruited.
Subjects will be evaluated sequentially with 18F-DTBZ during a 36 month period. 18F-DTBZ PET
scans will be performed twice, at baseline, and 24 (21~27) months following the start of
their participation in the study. Subjects will receive a single i.v. administration of
approximately 10 mCi 18F-DTBZ immediately prior to imaging. Whitney test will be used to
compare the mean standard uptake value ratio (SUVR) values between groups. The decline rate
of VMAT2 density will be calculated by comparing the SUVRs of age-matched healthy subjects
from our previous studies. Each evaluable subject involved in this study must fulfill all
the inclusion and exclusion criteria according the subject grouping, each subject will have
3 visits in each scan (total 6 visits in this study), as one screening visit, one imaging
visit, and one safety evaluation visit.
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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