18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism

Phase 2

Completed

• Conditions: Vascular Parkinsonism
• Interventions: Drug: 18F-DTBZ

• Registration Number: NCT02195154
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the study. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria and each subject will have 3 visits in the study, as one screening visit, one imaging visit, and one safety evaluation visit.

Detailed Description

Study duration is expected to be completed in a period of 3 year. The study will enroll 40 patients with VP and 20 healthy subjects.

This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject group, each subject will have 3 visits in this study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Forty patients with a diagnosis of VP whom must: i. Male or female patients; age range 45~80 years old. ii. Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures.

iii. Patients should be fulfilled the diagnostic criteria of vascular parkinsonism (Appendix I).

2. Twenty healthy subjects whom must: i. Male or female patients; age range 45~80 years old. ii. Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures.

Exclusion Criteria

1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.

2. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.

   I. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.

   II. Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.)

3. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.

4. History or presence of QTc prolongation.

5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.

6. History of repeated head injury, hydrocephalus, encephalitis or cerebral tumors.

7. History of neurotoxin exposure

8. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus or encephalomalacia, will be excluded. Cerebral vascular lesions are allowed for VP patients. Mild cortical atrophy will be allowed for all subjects.

9. Patients who have neurodegenerative diseases, such as spinocerellar atrophy (SCA), Wilson's disease, Parkinson's disease or Parkinson plus syndrome, are excluded.

10. General PET exclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DTBZ for Vascular Parkinsonism	18F-DTBZ	This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject group, each subject will have 3 visits in this study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Primary Outcome Measures

Name	Time	Method
The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group	3 years

Secondary Outcome Measures

Name	Time	Method
The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group.	3 years	The neuroimaging parameters include the SURs of 18F-DTBZ in each brain regions, diffusion indices in each brain regions, MARS score, and activated voxels in each brain regions from the gait-related imagery task functional MRI.

Trial Locations

Locations (1)

Chang Gung Memory Hospital; 🇨🇳 Taoyuan, Taiwan