6 results
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in…
Primary- Part 1: To identify recommended Phase 2 doses and schedules (RP2Ds) for each combination.- Part 2: To characterize the safety of each RP2D for each combinationSecondary- To characterize the pharmacokinetics and pharmacodynamics of each…
This protocol is a follow-up of a previously submitted protocol (Evaluation of [18F]AV-1451 kinetic modelling in patients with Alzheimer*s Disease and healthy controls, protocol nr. 2014.519), in which the optimal (simplified) kinetic model for [18F…
Primary objective:To explore the natural time course of specific [18F]AV-1451 binding in patients with subjective cognitive decline after two and four year follow upa. To compare rate of change in [18F]AV-1451 binding according to baseline amyloid…
Primary objectiveThe primary objective of the study is to determine the effect of lucerastat on neuropathic pain in subjects with Fabry disease (FD).Secondary objectives* To determine the effects of lucerastat on gastro-intestinal (GI) symptoms (…
Primary objectiveThe primary objective of the study is to determine the long term safety and tolerability of lucerastat in subjects with Fabry disease (FD).Secondary objectives* To evaluate the effect of lucerastat on renal function and cardiac…