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

NCT ID: NCT01556100

Last Updated: 2017-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Keywords

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18F-DTBZ AV-133 imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-DTBZ AV-133

18F-DTBZ AV-133 imaging

Group Type EXPERIMENTAL

18F-DTBZ AV-133

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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99-3989A

Identifier Type: -

Identifier Source: org_study_id