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

NCT02195154 | Completed Phase 2 DMC

• 1 other identifier: 101-4624A
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Parkinsonism

Keywords

18F-DTBZ

Outcome Measures

Primary Outcomes (1)

• The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group

  3 years

Secondary Outcomes (1)

• The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group.

  3 years

Other Outcomes (3)

• The difference of diffusion indices obtained from DTI between disease and control group

  3 years

• The difference of microbleed anatomical rating scale (MARS) score obtained from the SWI between disease and control group.

  3 years

• The difference of functional connectivity maps associated with the seed region of interest (resting state functional MRI) between disease and control group.

  3 years

Study Arms (1)

18F-DTBZ for Vascular Parkinsonism

EXPERIMENTAL

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.

Drug: 18F-DTBZ

Interventions

18F-DTBZ DRUG

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The compound is labeled with fluorine 18F that decays by positron (β+) emission and has a half life of 109.7 min. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron. The proposed dose for this study is based on the phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.

18F-DTBZ for Vascular Parkinsonism

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Memory Hospital

Taoyuan District, 333, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: July 21, 2014
• Study Start: November 1, 2013
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

TW (1)