Phase 2
Completed N=40
Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
Source: ClinicalTrials.gov NCT01556100 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 — 12.95 SUVR
Summary
A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 |
12.95 | — |
| SECONDARY To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. |
12.95 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female age 20 years to 80 years.
- Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible" or "probable" PD1.
- 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
- Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
- Alcohol or substance abuse.
- History or presence of QTc prolongation. (>500msec)
- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- Unable to stay still in the MRI or PET scanner for 30 minutes.
- Pregnancy and breast feeding.
- Hepatic dysfunction with liver function test (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of > 3x the upper limit of normal
Data sourced from ClinicalTrials.gov (NCT01556100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.