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Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression

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ClinicalTrials.gov Identifier: NCT01556100
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: 18F-DTBZ AV-133 Phase 2

Detailed Description:

The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients.

This study is expected to be completed in a period of 4 years.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
Study Start Date : November 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 18F-DTBZ AV-133
18F-DTBZ AV-133 imaging
Drug: 18F-DTBZ AV-133
A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.



Primary Outcome Measures :
  1. Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 [ Time Frame: three years ]
    To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD.


Secondary Outcome Measures :
  1. To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. [ Time Frame: three years ]

    The test/retest reliability will be estimated from a subgroup of the study subjects (10 subjects) who receive additional scan within 4 weeks since baseline image.

    In order to refine the definition of a positive 18F-DTBZ in patient with PD as compared to healthy control, quantitative measurement will be used. The standard uptake value (SUV) of each brain regions will be calculated. The SUV is a widely used, simple PET quantifier, calculated as a ratio of tissue radioactivity concentration (e.g. in units kBq/ml) at time t, CPET(t) and injected dose (e.g. in units MBq) at the time of injection divided by body weight (e.g. in units kg).SUV = CPET(t) / (Injected dose / Patient's weight), t =90min, and the unit of SUV is g/ml.




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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female age 20 years to 80 years.
  2. Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible" or "probable" PD1.
  3. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent)

Exclusion criteria:

  1. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
  2. Alcohol or substance abuse.
  3. History or presence of QTc prolongation. (>500msec)
  4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
  5. Unable to stay still in the MRI or PET scanner for 30 minutes.
  6. Pregnancy and breast feeding.
  7. Hepatic dysfunction with liver function test (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of > 3x the upper limit of normal

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01556100     History of Changes
Other Study ID Numbers: 99-3989A
First Posted: March 16, 2012    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: November 2016

Keywords provided by Chang Gung Memorial Hospital:
18F-DTBZ AV-133 imaging

Additional relevant MeSH terms:
Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes