Targeting Monoaminergic Neuronal Networks in the Parkinsonian Patients After Carbon Monoxide Intoxication
Primary Purpose
Carbon Monoxide-induced Parkinsonism
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
18F-FP-(+)-DTBZ
Sponsored by
About this trial
This is an interventional diagnostic trial for Carbon Monoxide-induced Parkinsonism focused on measuring carbon monoxide intoxication, Parkinsonism, 18F-DTBZ AV-133
Eligibility Criteria
Inclusion criteria
- Male or female age 20 years to 65 years.
- Patients group should fulfilled diagnostic criteria of carbon monoxide intoxication
- 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 consent)
Exclusion criteria
- History of developmental disorders, agitated mood or a confused state that prevented either a neuropsychiatric interview or neuroimaging.
- Unable to stay still in the PET scanner for 30 minutes.
- History or presence of QTc prolongation. (>500msec)
- Pregnancy and breast feeding.
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-FP-(+)-DTBZ only
Arm Description
PET tracer: 18F-FP-(+)-DTBZ
Outcomes
Primary Outcome Measures
Assess the regional decline in 18F-DTBZ uptake of Parkinsonism after carbon monoxide intoxication
This study will assess the brain uptake and distribution of 18F-DTBZ in 25 carbon monoxide intoxication patients with Parkinsonism. For each patient, the PET will be arranged twice, with an interval of 1.5 years.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02138864
Brief Title
Targeting Monoaminergic Neuronal Networks in the Parkinsonian Patients After Carbon Monoxide Intoxication
Official Title
Targeting Monoaminergic Neuronal Networks in the Parkinsonian Patients After Carbon Monoxide Intoxication
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its correlation with clinical parameters. This study is expected to be completed in a period of 3 years.
Detailed Description
With the urbanization of Taiwanese society, there are increasing numbers of people committing suicide by charcoal burning, making carbon monoxide (CO) encephalopathy a new pandemic phenomenon. In CO related parkinsonism, the clinical features included gait disturbances, mask face, rigidities and small steps. From literature searches, the CO related parkinsonism is related to white matter damages or decline in dopamine innervations. From our previous research results, the CO related neuronal damages would started from reversible or progressive white matter demyelination. For some patients, axonopathy or gray matter atrophy developed and became irreversible. The neuronal networks in determining development of Parkinsonism required to be established.
In terms of neurotransmitter, most of the clinical data for Parkinsonism came from studies of idiopathic Parkinson's disease while the data of CO related Parkinsonism were limited to case reports. From neuropathology studies in idiopathic Parkinson's disease, dopamine deficits and decreased in monoamine transporters were observed well before the development of clinical features. Although there is linkage between CO related Parkinsonism and dopamine deficits, patients with CO intoxication had poor response to levodopa. The observation suggested the critical networks and neurotransmitters were still not well understood.
18F-FP-(+)-DTBZ is a newly developed nuclear medicine tracer for monoamine transporter. The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its correlation with clinical parameters. This is a three-year prospective research. For each patient, the PET will be arranged twice, with an interval of 18 months. The regional distribuation of 18F-FP-(+)-DTBZ in relation to Parkinsonism severity and regional reduction patterns longitudially will be assessed in order to understand the regional neurotoxicity and the functional progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide-induced Parkinsonism
Keywords
carbon monoxide intoxication, Parkinsonism, 18F-DTBZ AV-133
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-FP-(+)-DTBZ only
Arm Type
Experimental
Arm Description
PET tracer: 18F-FP-(+)-DTBZ
Intervention Type
Radiation
Intervention Name(s)
18F-FP-(+)-DTBZ
Intervention Description
no available
Primary Outcome Measure Information:
Title
Assess the regional decline in 18F-DTBZ uptake of Parkinsonism after carbon monoxide intoxication
Description
This study will assess the brain uptake and distribution of 18F-DTBZ in 25 carbon monoxide intoxication patients with Parkinsonism. For each patient, the PET will be arranged twice, with an interval of 1.5 years.
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Male or female age 20 years to 65 years.
Patients group should fulfilled diagnostic criteria of carbon monoxide intoxication
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 consent)
Exclusion criteria
History of developmental disorders, agitated mood or a confused state that prevented either a neuropsychiatric interview or neuroimaging.
Unable to stay still in the PET scanner for 30 minutes.
History or presence of QTc prolongation. (>500msec)
Pregnancy and breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiung-Chih Chang, M.D.; Ph.D
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Targeting Monoaminergic Neuronal Networks in the Parkinsonian Patients After Carbon Monoxide Intoxication
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