drugset / Trial / NCT02187627

Evaluation of [11C]RO6924963, [11C]RO6931643, and [18F]RO6958948 as Tracers for Positron Emission Tomography (PET) Imaging of Tau in Healthy and Alzheimer's Disease (AD) Participants

NCT02187627 ↗

Phase 1 Completed 52 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelBasic science

Summary

This study is designed to obtain basic information on three PET imaging tracers developed to detect tau pathology in the brain. In this study, healthy control participants and participants with AD will be studied. Information collected will include brain and plasma kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest variability of the signal in the brain. The study will consist of Part 1, Part 2A, and Part 2B. During Part 1, imaging data will be assessed on an ongoing basis and based on data, one tracer will be prioritized over the other two tracers. The tracer selected will be further investigated in Part 2A and Part 2B.

Timeline

Start
2014-08-31
Primary completion
2016-02-29
Completion
2016-02-29

Drugs

EvaluationDrugModalityDoseRoute
Subject [11C]RO6924963 Diagnostic / imaging agent 10 ug Intravenous
Subject [11C]RO6924963 Diagnostic / imaging agent 370 mbq Intravenous
Subject [11C]RO6924963 Diagnostic / imaging agent 740 mbq Intravenous
Subject [11C]RO6931643 Diagnostic / imaging agent 10 ug Intravenous
Subject [11C]RO6931643 Diagnostic / imaging agent 370 mbq Intravenous
Subject [11C]RO6931643 Diagnostic / imaging agent 740 mbq Intravenous
Subject [18F]RO6958948 Diagnostic / imaging agent 10 ug Intravenous
Subject [18F]RO6958948 Diagnostic / imaging agent 185 mbq Intravenous
Subject [18F]RO6958948 Diagnostic / imaging agent 370 mbq Intravenous

Indications