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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01556100
First received: March 6, 2012
Last updated: January 27, 2016
Last verified: December 2015
  Purpose
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 Intervention Phase
Parkinson Disease
Drug: 18F-DTBZ AV-133
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Evaluate the changes in 18F-DTBZ uptake in a cohort of Parkinson's disease patients from baseline to month 18, and 36. [ Time Frame: Four years ] [ Designated as safety issue: Yes ]
    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:
  • Determine whether the rate of reduction in 18F-DTBZ uptake in sequential PET imaging during a 36 month interval will correlate with changes in the clinical measures of severity of disease. [ Time Frame: Four years ] [ Designated as safety issue: Yes ]
    To expand the safety database of 18F-DTBZ PET imaging Safety variables include adverse event count, lab parameters, vital signs, and ECG. Comparison will be generally made to baseline, as appropriate.


Enrollment: 40
Study Start Date: November 2011
Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01556100     History of Changes
Other Study ID Numbers: 99-3989A 
Study First Received: March 6, 2012
Last Updated: January 27, 2016
Health Authority: Taiwan : Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016