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Targeting Monoaminergic Neuronal Networks in the Parkinsonian Patients After Carbon Monoxide Intoxication

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ClinicalTrials.gov Identifier: NCT02138864
Recruitment Status : Unknown
Verified May 2016 by chiungchihchang, Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 15, 2014
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
chiungchihchang, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Carbon Monoxide-induced Parkinsonism Radiation: 18F-FP-(+)-DTBZ Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeting Monoaminergic Neuronal Networks in the Parkinsonian Patients After Carbon Monoxide Intoxication
Study Start Date : August 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-FP-(+)-DTBZ only
PET tracer: 18F-FP-(+)-DTBZ
Radiation: 18F-FP-(+)-DTBZ
no available




Primary Outcome Measures :
  1. Assess the regional decline in 18F-DTBZ uptake of Parkinsonism after carbon monoxide intoxication [ Time Frame: up to 3 years ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Male or female age 20 years to 65 years.
  2. Patients group should fulfilled diagnostic criteria of carbon monoxide intoxication
  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 consent)

Exclusion criteria

  1. History of developmental disorders, agitated mood or a confused state that prevented either a neuropsychiatric interview or neuroimaging.
  2. Unable to stay still in the PET scanner for 30 minutes.
  3. History or presence of QTc prolongation. (>500msec)
  4. Pregnancy and breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138864


Locations
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Taiwan
Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 886
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chiung-Chih Chang, M.D.; Ph.D Chang Gung Memorial Hospital
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Responsible Party: chiungchihchang, MD, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02138864    
Other Study ID Numbers: 101-4350A
CDE102IND01009 ( Registry Identifier: CHIUNH-CHIH CHANG )
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by chiungchihchang, Chang Gung Memorial Hospital:
carbon monoxide intoxication
Parkinsonism
18F-DTBZ AV-133
Additional relevant MeSH terms:
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Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders