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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22467
Enrollment
20
Registered
2016-02-11
Start date
2016-02-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory Attention

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.

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
The primary endpoint is the behavioral scores on a memory paradigm, namely a verbal learning task.

Contacts

Public ContactLaura Borghans

Faculty of Psychology Dept. of Neuropsychology and Psychopharmacology

lgjm.borghans@maastrichtuniversity.nl0031-(0)43-3881530

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)