Status:
COMPLETED
18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Vascular Parkinsonism
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
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 a...
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 stru...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.)
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- History or presence of QTc prolongation.
- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- History of repeated head injury, hydrocephalus, encephalitis or cerebral tumors.
- History of neurotoxin exposure
- 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.
- Patients who have neurodegenerative diseases, such as spinocerellar atrophy (SCA), Wilson's disease, Parkinson's disease or Parkinson plus syndrome, are excluded.
- General PET exclusion criteria.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02195154
Start Date
November 1 2013
End Date
July 31 2017
Last Update
January 31 2018
Active Locations (1)
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1
Chang Gung Memory Hospital
Taoyuan District, Taiwan, 333