No registrations found.
ID
Source
Brief title
Health condition
Memory
Attention
Sponsors and support
Intervention
Outcome measures
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.
Intervention
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.
Faculty of Psychology Dept. of Neuropsychology and Psychopharmacology
Laura Borghans
PO Box 616
Maastricht 6200 MD
The Netherlands
0031-(0)43-3881530
lgjm.borghans@maastrichtuniversity.nl
Faculty of Psychology Dept. of Neuropsychology and Psychopharmacology
Laura Borghans
PO Box 616
Maastricht 6200 MD
The Netherlands
0031-(0)43-3881530
lgjm.borghans@maastrichtuniversity.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5563 |
| NTR-old | NTR5684 |
| Other | METC AZM/UM : 153012 |