drugset / Trial / NCT00702143

A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

NCT00702143 ↗

Phase 2 Completed 184 enrolled Avid Radiopharmaceuticals
Non-randomizedSingle-groupSingle-blindDiagnostic

Summary

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Timeline

Start
2008-06
Primary completion
2008-12
Completion
2008-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); AD Subjects vs MCI Subjects; p = 0.0002; Fisher Exact NCT00702143 ↗

registry analysis (superiority or other test); AD Subjects vs Healthy Controls; p <0.0001; Fisher Exact NCT00702143 ↗

registry analysis (superiority or other test); AD Subjects vs MCI Subjects vs Healthy Controls; p <0.0001; ANOVA NCT00702143 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject florbetapir F 18 Diagnostic / imaging agent 370 mbq Intravenous