Prospective evaluation of potential effects of repeated gadoliniumbased contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group ODYSSEY
Objective
Primary Objective: To prospectively assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA exposed control group. Secondary Objectives:
To assess the change from baseline in the composite endpoints (motor and cognitive) at each of the post-baseline time points (Years 1 to 4) in GBCA-exposed participants as compared to controls.
To assess the change from baseline for each of the individual tests (motor and cognitive) at each of the post-baseline time points (Years 1 to 5) in GBCA-exposed participants as compared to controls.
To evaluate safety through collection of adverse events.
To assess total Gd concentrations (as measured in a central laboratory) in blood and urine samples taken from exposed and control participants at the time of annual visit.