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Completed

NCT Number: NCT01433666

Roflumilast and Cognition

The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast in healthy humans.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maastricht University, Faculty of Psychology and Neuroscience

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 memory screening

Exclusion criteria

  • History of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness
  • First-degree relative with psychiatric disorder (in particular major depressive disorder and suicidality)
  • Excessive drinking (>20 glasses of alcohol containing beverages per week)
  • Pregnancy or lactation
  • Use of chronic medication other than oral contraceptives
  • Use of recreational drugs in the 2 weeks preceding participation
  • Smoking
  • Orthostatic hypotension
  • Lactose intolerance
  • Sensory or motor deficits which could reasonably be expected to affect test performance

Treatment and study plan

roflumilast (EU: Daxas, USA: Daliresp)

Drug

Acute intervention: 1 time each dose on different days. Capsulated

Placebo

Drug

Acute intervention: single administration, capsulated form.

Roflumilast

Drug

Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.

Other names: Daxas, Daliresp, PDE4-inhibitor

Primary outcomes

  1. Number of words remembered on Verbal learning task

    Time frame: 1hr after drug intake

    30 monosyllable words will be displayed on a computer screen. Immediately after the presentation and after 45 minutes, subjects will be asked to report as much words as they remember. In addition, a recognition trial is conducted. Here, 30 words will be presented; 15 new words and 15 from the original list. Subjects have to indicate whether the word is old or new.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study

Acronym: EEGrofl

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 14, 2011
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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