drugset / Trial / NCT01662882
A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Non-randomizedSingle-groupOpen-labelDiagnostic
Summary
Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
Timeline
- Start
- 2012-10
- Primary completion
- 2013-02
- Completion
- 2013-02
Outcome
Met primary endpoint
registry analysis (superiority or other test); AD Subjects vs MCI Subjects vs Healthy Controls; p = 0.0008; Fisher Exact NCT01662882 ↗
registry analysis (superiority or other test); AD Subjects vs MCI Subjects vs Healthy Controls; p = 0.0039; ANOVA NCT01662882 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | florbetapir F 18 | Diagnostic / imaging agent | 370 mbq | Intravenous |