Long term 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 effects regarding.
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Iqvia Rds France
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France, Germany, Italy
Outcome results
None listed