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

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Taiwan

Chang Gung Memorial Hospital

Kaohsiung, Taiwan, 886

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

• Principal Investigator: Chiung-Chih Chang, M.D.; Ph.D; Chang Gung Memorial Hospital

More Information

• 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
• 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:

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders