Prospective evaluation of potential effects of repeated gadolinium-based 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

Trial status: Authorised Changes from baseline in the composite endpoint (Years 1 to 4) and in each individual test of motor and cognitive function (Years 1 to 5) will be assessed., Evaluation of AEs. The recording of AEs that occur after signing of the informed consent form (ICF) at Screening, will be done at baseline and at each annual visit. Signs/symptoms, onset date/time, severity, causality, seriousness, treatment and outcome will be recorded., Total gadolinium concentrations in blood plasma and urine samples collected at baseline and at each annual visit will be determined. If the CE-MRI is obtained at the same visit, the blood and urine samples will be obtained prior to imaging. The co-primary endpoints are the change from baseline to Year 5 in motor function and in cognitive function as expressed by the composite z score, defined as the weighted sum of the z scores of the individual tests. Since each of these tests is considered equally important, each test will be assigned an equal weight.

Changes from baseline in the composite endpoint (Years 1 to 4) and in each individual test of motor and cognitive function (Years 1 to 5) will be assessed., Evaluation of AEs. The recording of AEs that occur after signing of the informed consent form (ICF) at Screening, will be done at baseline and at each annual visit. Signs/symptoms, onset date/time, severity, causality, seriousness, treatment and outcome will be recorded., Total gadolinium concentrations in blood plasma and urine samples collected at baseline and at each annual visit will be determined. If the CE-MRI is obtained at the same visit, the blood and urine samples will be obtained prior to imaging.

Age group: 18-64 years Gender: Female, Male Target enrollment: 717 participants