Status:
COMPLETED
The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Parkinson's Disease
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders, including multi...
Detailed Description
40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP, will be enrolled. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion ...
Eligibility Criteria
Inclusion
- Forty subjects with a diagnosis of PD whom must:
- i.Male or female patients, age range 20\~80. ii.Patients should be fulfilled Criteria of diagnosis of Parkinson disease8 of "possible" or "probable" PD (Appendix I).
- iii.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).
- Forty subjects with a diagnosis of MSA whom must:
- i.Male or female patients, age range 20\~80. ii.Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix II).
- iii. 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).
- Twenty subjects with a diagnosis of PSP whom must:
- i.Male or female patients, age range 20\~80. ii.Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP of "possible" or "probable" PSP35 (Appendix III).
- iii.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).
- Twenty subjects with a diagnosis of CBD whom must:
- i.Male or female patients, age range 20\~80. ii.Patients should be fulfilled the Kumar's criteria of CBD36 (Appendix IV). iii.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
- Pregnant or becoming pregnant during the study or current breast feeding.
- Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
- i.Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.
- ii.Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- History or presence of QTc prolongation.
- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
- Patients who have the evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases, such as spinocerebellar atrophy (SCA), Wilson's disease, hydrocephalus, multiple infarction, serious head injury and definite history of neurotoxin exposure, are excluded.
- General PET exclusion criteria.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01824056
Start Date
August 1 2010
End Date
July 1 2013
Last Update
November 13 2013
Active Locations (1)
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1
Chang Gung Memory Hpspital
Taoyuan District, Taiwan, Taiwan, 333