12 results
To study how the registered medicine Midazolam is absorbed, broken-down and excreted by the body after or without administration of multiple doses of the test compound.To study how the registered medicine Dextromethorphan is absorbed, broken-down…
Supported by the observation from the Phase I studies in healthy volunteers, doses within a range of 50 to 500 mg are safe and well tolerated. This Phase II trial will be performed to:a. obtain proof of concept of BI 44370 TAb. perform dose finding…
The primary efficacy objective for this study was to evaluate the efficacy of gantenerumab compared with placebo administered to patients by subcutaneous (SC) injection over 100 weeks as measured by the following co-primary endpoints (final outcome…
The primary objective of this secondary prevention study is to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of gantenerumab, an anti-amyloid antibody, in amyloid-positive, cognitively unimpaired participants at risk for or…
This study will evaluate the efficacy and safety of gantenerumab compared with placebo in patients with early (prodromal to mild) Alzheimer's disease (AD).
In this study we will investigate how safe the new compound deramciclane is, when it is given alone and in combination with the existing medication dextromethorphan (Part B), and how well it is tolerated when it is used by healthy elderly…
To assess short-term and long-term safety and tolerability of gantenerumab (RO4909832) given at doses up to 1200mg subcutaneous (SC) every 4 weeks (Q4W).Secondary Objective of the Open-label extension:- To evaluate of the effect of 1200 mg…
Primary objective:Evaluate the effect of two doses versus placebo gantenerumab subcutaneous injections on the change in Clinical Dementia Rating Sum of Boxes scale (CDR SOB), a global measure of cognition and functional capacitySecondary objectives:…
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
The primary objective for this study is to evaluate the safety, tolerability and efficacy of long-term gantenerumab administered by SC injection.
The main objective of this study is to continue to collect long-term safety and tolerabilitydata in participants with AD treated with gantenerumab. Specific objectives andcorresponding endpoints for the study are outlined in Table 1 of the protocol
Part IPrimary: • To evaluate safety and tolerability of ODM-111 in single oral escalating doses compared to placeboSecondary: • To evaluate pharmacokinetics (PK) and pharmacodynamic (PD) effects of ODM-111 after administration of single escalating…