Vascular Parkinsonism Clinical Trial
Official title:
18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism: Investigating the Correlation Between Cerebral Structural and Functional Changes, and Clinical Manifestation
Verified date | January 2018 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 31, 2017 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memory Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The difference of diffusion indices obtained from DTI between disease and control group | 3 years | ||
Other | The difference of microbleed anatomical rating scale (MARS) score obtained from the SWI between disease and control group. | 3 years | ||
Other | The difference of functional connectivity maps associated with the seed region of interest (resting state functional MRI) between disease and control group. | 3 years | ||
Primary | The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group | 3 years | ||
Secondary | The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group. | 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. | 3 years |
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