drugset / Trial / NCT01607476

Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)

NCT01607476

Phase 2 Completed 89 enrolled Mayo Clinic
Non-randomizedParallel-groupOpen-labelBasic science

Summary

The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.

Timeline

Start
2012-07
Primary completion
2014-12
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject C-11 PiB Diagnostic / imaging agent 296 mbq Intravenous
Subject C-11 PiB Diagnostic / imaging agent 814 mbq Intravenous
Subject F18 Flutametamol Unknown 111 mbq Intravenous
Subject F18 Flutametamol Unknown 259 mbq Intravenous

Indications