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

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

NCT02195154•Chang Gung Memorial Hospital

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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.

Eligibility

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (1)

Chang Gung Memory Hospital

Taoyuan District, Taiwan

Key Dates

Start Date

November 1, 2013

Primary Completion Date

July 31, 2017

Completion Date

July 31, 2017

Last Updated

January 31, 2018

Enrollment

ACTUAL participants

Conditions

Vascular Parkinsonism

Interventions

18F-DTBZ

DRUG

The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders

NCT06174948

Parkinson's Disease and ParkinsonismProgressive Supranuclear Palsy+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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