Phase 2
Completed N=25
Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects
Healthy
Source: ClinicalTrials.gov NCT01838785 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects. — 0.05 SUVR
Summary
A total 25 healthy subjects will be included in this study. 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 Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects. |
0.05 | — |
| SECONDARY The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects. |
2.35 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female age 20 years to 80 years.
- Subjects without significant neuropsychiatric disorder after evaluation by Neurologist.
- Subjects who provide a written informed consent prior to study entry. If the subject is incapable of informed consent, the caregiver may consent on behalf of the subject (the subject must still confirm assent).
Exclusion Criteria
- Pregnancy and breast feeding.
- Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
- Alcohol or substance abuse within last year.
- Parkinson's disease or other brain degenerative disease (spinocerebellar ataxia, Wilson's disease, hydrocephalus, multiple infarction, history of severe head injury or intracranial operation.
- Unable to stay still in the MRI or PET scanner for 30 minutes.
Data sourced from ClinicalTrials.gov (NCT01838785). 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.