18F-DTBZ for l Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging — 8F-DTBZ  

Parkinson's Disease Clinical Trial

Official title: Phase II Study of 18F-DTBZ: The Differential Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging

Status Completed

Clinical Trial Summary

The primary objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's Disease (PD) and normality. Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease severity.

Clinical Trial Description

25 age-matched healthy volunteers will be enrolled. For assessing the correlation between the 18F-DTBZ binding and the severity of disease, the patients with PD will be divided into three groups according to their motor scores: mild, moderate, and advanced. We will enroll 25 patients in each group. 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 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT01283347
• Study type: Interventional
• Source: Chang Gung Memorial Hospital
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Completion date: December 2012