The primary objective is to examine whether vardenafil (a PDE-5 inhibitor) can improve the cognition of healthy young volunteers. Secondary, we will assess the effects of vardenafil on electrophysiological correlates of cognition.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the behavioural score on the memory tests; the verbal
learning task (VLT), the object relocation task (ORT) and the continuous
recognition memory task (CRMT),. Secondary, the event-related potentials during
those tasks will be analysed.
Secondary outcome
Other important measures are the Tower of London (TOL) and the Stroop task. In
addition, the visual and auditory evoked potentials (respectively VEPs and
AEPs), which will give an indication of the role of vardenafil in information
processing are important measures as well. Finally, the ratio (S2/S1) of the
P50 is a measure of sensory gating.
Background summary
Research on the neurobiological foundations of memory and learning has shown
that phosphodiesterase inhibitors increase the level of cGMP (cyclic Guanosine
Monophosphate), which plays a role in the induction of hippocampal long-term
potentiation (LTP). This is thought to be an important mechanism of learning
and memory. It has indeed been found that the administration of
phosphodiesterase type 5 (PDE-5) inhibitors improves memory performance in
rats. So far, only a few studies have examined the effects of PDE-5 inhibitors
on cognition in humans. The results of these studies, in which the PDE-5
inhibitor sildenafil was used, have been quite contradictory. Therefore, we
decided to use vardenafil which is a more selective PDE-5 inhibitor than
sildenafil, and as a result, more potent and has fewer side effects.
Study objective
The primary objective is to examine whether vardenafil (a PDE-5 inhibitor) can
improve the cognition of healthy young volunteers. Secondary, we will assess
the effects of vardenafil on electrophysiological correlates of cognition.
Study design
The study will be conducted according to a double-blind, placebo-controlled,
3-way cross-over design.
Intervention
Participants will be treated with vardenafil 10 mg, vardenafil 20 mg, or a
placebo. All treatments will be taken orally. The treatment order will be
established by counterbalancing.
Study burden and risks
The time investment for the participants will be around 13 hours in total,
which is comprised of 1) screening (around 30 min), 2) medical assessment by
questionnaire and medical checkup (around 1 hour), 3) training session in which
the tasks will be practised (around 2 hours), and 4) three test sessions of
around 3 hours, which include 45 minutes waiting. The day before a recording,
the participants are not allowed to drink any alcohol and are asked to eat only
nitrate-low food.
PO Box 616
6200 MD Maastricht
Nederland
PO Box 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Male or female, 18 to 35 years of age, Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected), Body mass index between 18.5 and 30, Willingness to sign an informed consent, Positive evaluation on the screening
Exclusion criteria
A history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness. Other exclusion criteria are excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives, use of recreational drugs from 2 weeks before until the end of the experiment, and any sensory or motor deficits which could reasonably be expected to affect test performance. Those volunteers who have a first-degree relative with a psychiatric disorder or a history of a psychiatric disorder will also be excluded.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-000785-23-NL |
| CCMO | NL21943.068.08 |