Clinical Trial Details
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NCT01759888 : Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism
PhasePhase 2
AgesMin: 20 Years Max: 80 Years
Inclusion Criteria:

1. Both genders and 20~80 years old.

2. Written and dated informed consent by self or by legal representative, to be obtained
before any of the study procedures.

3. Twenty PD patients were proved carrying LRRK2 G2385R mutation by our genetic
laboratory. Patients didn't have other mutations that may contribute to the
parkinsonism, such as LRRK2 G2019S, LRRK2 R1628P, PARK2, PARK6, and SCA2.

4. Twenty PARK6 PD patients were proved carrying PINK1 mutation by our genetic
laboratory. Patients didn't have other mutations that may contribute
to the parkinsonism, such as LRRK2, PARK2, and SCA2.

5. Twenty idiopathic PD patients were proved that they did not carry any known
mutations, which may contribute to the parkinsonism, such as LRRK2, PARK2, PARK6, and
SCA2. The age of disease onset should be more than 50 years, and no known familial
history of parkinsonism or spinocerebellar atrophy.

6. All the subjects should be fulfilled the UK Parkinson's Disease Society Brain Bank
criteria of "possible" or "probable" PD.

Exclusion Criteria:

1. Pregnant or becoming pregnant during the study 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.

1. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine
disturbances, especially thyroid disease.

2. 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

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

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, multiple infarction and
encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white
matter changes will be allowed.

7. Any evidence of secondary parkinsonism (multiple infarcts, intoxication, and
hydrocephalus, etc).

8. General PET exclusion criteria.
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