Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT01556100
• Date of registration: 06/03/2012
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
• Scientific title: Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
• Date of first enrolment: November 2011
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01556100
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female age 20 years to 80 years.

2. Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible"
or "probable" PD1.

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 assent)

Exclusion criteria:

1. Significant recent (within 6 months) history of neurological (including stroke and
brain trauma) or psychiatric disorder.

2. Alcohol or substance abuse.

3. History or presence of QTc prolongation. (>500msec)

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

5. Unable to stay still in the MRI or PET scanner for 30 minutes.

6. Pregnancy and breast feeding.

7. Hepatic dysfunction with liver function test (alanine aminotransferase [ALT] and
aspartate aminotransferase [AST]) of > 3x the upper limit of normal



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: 18F-DTBZ AV-133

Primary Outcome(s)

Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 [Time Frame: three years]

Secondary Outcome(s)

To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. [Time Frame: three years]

Secondary ID(s)

99-3989A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01556100