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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36123
Enrollment
44
Registered
2011-05-30
Start date
2011-11-08
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Geheugenproblemen nvt

Interventions

Participants will be treated with roflumilast 100 *g, roflumilast 300 *g, roflumilast 1000 *g,or a placebo. All treatments will be taken orally. The treatment order will be established by counterbal

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Secondary

MeasureTime frame
Other important measures are the Stroop task and continuous performance taak (CPT-AX). In addition, the event-related potentials during those tasks will be analysed. Moreover, the ratio (S2/S1) of the P50 is a measure of sensory gating.

Primary

MeasureTime frame
The main endpoint is the behavioural score on the memory tests; the verbal learning task (VLT) and the object relocation task (ORT).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)