119 results
This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…
In this study the potential of using the enhanced procedures for analyzing diffusion weighted data which were acquired according to clinical procedures is further investigated. The result is compared to the reconstruction of the OR based on high…
The objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…
The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…
To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults
The purpose of the study is to investigate the pharmacokinetics of S 44819. S 44819 is labeled with 14-Carbon (14C) and is thus radioactive (also called radiolabeled). In this way, S 44819 and its metabolites can be traced in blood, urine and feces…
To provide further insight into Souvenaid*s hypothesised mode of action, the current NL-ENIGMA study explores brain glucose metabolism in mild cognitive impairment (MCI) and mild dementia due to AD, using Positron Emission Tomography with 18F-FDG-…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.
The primary objective of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in subjects in the early AD spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ 54861911 (e.g., Study 54861911ALZ2002),…
This study aims to demonstrate the clinical efficacy of patisiran and to establish the safety of chronic dosing in ATTR patients with FAP.The primary objective of the study is to determine the efficacy of patisiran by evaluating the difference…
The aim of this study is to examine the daily level of activities and participation after LTH in children and adolescents (6-18 years) and to identify possible predictors. In addition, experimental research is done in a subgroup to measure the…
To examine the multiple dose effects of the study medication test compound in tinnitus after a 2-week treatment.
The purpose of this open label extension study is to gather further compliance and safety information on the longer-term (up to approximately 48 weeks) use of the study product. This will provide valuable information in addition to the findings of…
Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…
To determine the best dose escalation scheme of dipyridamole added to acetylsalicylic acid, based on the side-effect headache, in patients starting secondary preventive therapy for stroke
The purpose of this study is to evaluate the benefit of adding an adjuvant to CAD106 and to select the dose of CAD106 and adjuvant to be used in further development. Additionally, clinical and biomarker measures (CSF, plasma biomarkers, volumetric…
* To examine how multiple oral doses of the test compound (an experimental medication) will be taken up by the body, metabolized and excreted by the body in combination with the oral contraception pill which consists of ethinyl-estradiol and…
To develop reliable and feasible aerobic and anaerobic exercise tests for children with spastic CP who use wheelchairs.
- to assess the excretion balance of total radioactivity in urine and faeces after single oral dose of 20 mg 2.35 MBq (64 µCi) of [14C]-S 47445, - to determine the pharmacokinetics of the total radioactivity in whole blood, plasma and urine after…
The purpose of the study is to find out if there is a possible influence of Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it will be investigated whether and if so to what extent Ketoconazole influences how fast…