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

December 13, 2017 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Actual)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-3989A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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