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van CCT (UK)

van CCT (UK)

Can the sGC stimulator Adempas (riociguat) improve cognitive functioning in healthy volunteers?

- candidate number23948
- NTR NumberNTR5684
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2016
- Secondary IDs153012 METC AZM/UM
- Public TitleCan the sGC stimulator Adempas (riociguat) improve cognitive functioning in healthy volunteers?
- Scientific TitleCan the sGC stimulator Adempas (riociguat) improve cognitive functioning in healthy volunteers?
- ACRONYMsGC stimulator and cognitive improvement
- hypothesis
- Healt Condition(s) or Problem(s) studiedMemory, 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-feb-2016
- planned closingdate
- Target number of participants20
- InterventionsParticipants 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 outcomeThe primary endpoint is the behavioral scores on a memory paradigm, namely a verbal learning task.
- Secondary outcomeSecondary 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.
- Timepoints
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-feb-2016 - 4-apr-2016

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