|- candidate number||23948|
|- NTR Number||NTR5684|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-feb-2016|
|- Secondary IDs||153012 METC AZM/UM|
|- Public Title||Can the sGC stimulator Adempas (riociguat) improve cognitive functioning in healthy volunteers?|
|- Scientific Title||Can the sGC stimulator Adempas (riociguat) improve cognitive functioning in healthy volunteers?|
|- ACRONYM||sGC stimulator and cognitive improvement|
|- Healt Condition(s) or Problem(s) studied||Memory, Attention|
|- Inclusion criteria||• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.|
• The participant is aged 18 to 40 years, inclusive, at the time of informed consent.
• The participant has a body mass index of 18.5-30 kg/m2, inclusive, at medical screening.
• The volunteer is healthy, i.e. absence of all exclusion criteria and has normal static binocular acuity.
• The participant signs and dates a written informed consent form before the start of the experiments.
|- Exclusion criteria||• The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.|
• The volunteer has uncontrolled existing major psychiatric symptoms.
• The subject has uncontrolled hypo- or hypertension.
• The participant has known hypersensitivity to any component of the formulation of riociguat or biperiden or related compounds.
• The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
• The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
• Other exclusion criteria are smoking, excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-feb-2016|
|- planned closingdate|
|- Target number of participants||20|
|- Interventions||Participants will participate on 6 separate test days and will be administered either biperiden, riociguat, a combination, or a placebo. The order of treatment will be counterbalanced. |
|- Primary outcome||The primary endpoint is the behavioral scores on a memory paradigm, namely a verbal learning task.|
|- Secondary outcome||Secondary endpoints are performance on the visual N-back test, a spatial memory task (SMT), the attention network test (ANT) and a simple and choice reaction task, the scores on the POMS and complaints questionnaire.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Laura Borghans|
|- CONTACT for SCIENTIFIC QUERIES|| Anke Sambeth|
|- Sponsor/Initiator ||Maastricht University|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||11-feb-2016 - 4-apr-2016|