Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02059733
• Date of registration: 07/02/2014
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism
• Scientific title: Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PET
• Date of first enrolment: February 2013
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02059733
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Taiwan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Twenty subjects with a diagnosis of PD whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled "UK
Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of 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).

2. Twenty 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 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).

3. 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 " as possible" or "probable"
PSP55 (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).

4. Twenty subjects with a diagnosis of CBS whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the"Mayo
Clinic proposed criteria for the diagnosis for corticobasal syndrome"56 (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).

5. Twenty subjects with a diagnosis of VaP whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the
clinical diagnostic criteria of vascular parkinsonism. (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).

6. Twenty subjects with a diagnosis of ET whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The
Consensus Criteria of the MDS on Essential Tremor"30. (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).

7. Ten subjects with a diagnosis of DT whom must:

i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The
Consensus Criteria of the MDS on Dystonic Tremor"30. (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).

Exclusion Criteria:

1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at
screening or at any date during the study according to the PI discretion) or current
breast feeding..

2. 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.

3. History of drug or alcohol abuse within the last year, or prior prolonged history of
abuse.

4. History or presence of QTc prolongation.

5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep
brain stimulation.

6. Any documented abnormality in the brain by CT or MRI of brain, which might contribute
to the motor function, such as hydrocephalus and encephalomalacia, will be excluded.
Mild cortical atrophy and non-specific white matter changes will be allowed.

7. Patients who have the evidence of secondary parkinsonism or other neurodegenerative
diseases, such as spinocerellar atrophy (SCA), Wilson's disease, hydrocephalus ,
serious head injury and definite history of neurotoxin exposure, are excluded.

8. History of allergy to radioligands that contain 18F isotope.



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: 18F-DTBZ

Primary Outcome(s)

Analyzing the differences of monoaminergic degeneration between each group by comparing the SUVR of 18F- DTBZ measured by the VOIs methods in each brain region. [Time Frame: 4 years]

Secondary Outcome(s)

Statistical parametrical mapping will be performed to compare the early-phase and delayed-phase imaging of 18F- DTBZ PET in each group. [Time Frame: 4 years]

Secondary ID(s)

101-1273A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors