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Effects of roflumilast on cognition in healthy adults: a behaviour-EEG study

Phase 3
Completed
Conditions
Geheugenproblemen
nvt
Registration Number
NL-OMON36123
Lead Sponsor
niversiteit Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
44
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 medical and memory screening

Exclusion Criteria

Volunteers who suffer from, or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness, will be excluded. Other exclusion criteria are excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of chronic medication other than oral contraceptives, use of recreational drugs from 2 weeks before until the end of the experiment, smoking, ortostatic hypotension, lactose intolerance, 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 depressive disorder with or without suicidal risk will be excluded as well.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main endpoint is the behavioural score on the memory tests; the verbal<br /><br>learning task (VLT) and the object relocation task (ORT). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Other important measures are the Stroop task and continuous performance taak<br /><br>(CPT-AX). In addition, the event-related potentials during those tasks will be<br /><br>analysed. Moreover, the ratio (S2/S1) of the P50 is a measure of sensory<br /><br>gating.</p><br>
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