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Roflumilast and Cognition (EEGrofl)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433666
First Posted: September 14, 2011
Last Update Posted: September 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Marlies van Duinen, Maastricht University Medical Center
  Purpose
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.

Condition Intervention Phase
Dementia Drug: roflumilast (EU: Daxas, USA: Daliresp) Drug: Placebo Drug: roflumilast Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study

Resource links provided by NLM:


Further study details as provided by Marlies van Duinen, Maastricht University Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: roflumilast 100ug Drug: roflumilast (EU: Daxas, USA: Daliresp)
Acute intervention: 1 time each dose on different days. Capsulated
Drug: roflumilast
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
Other Names:
  • Daxas
  • Daliresp
  • PDE4-inhibitor
Experimental: roflumilast 300ug Drug: roflumilast (EU: Daxas, USA: Daliresp)
Acute intervention: 1 time each dose on different days. Capsulated
Drug: roflumilast
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
Other Names:
  • Daxas
  • Daliresp
  • PDE4-inhibitor
Experimental: roflumilast1000ug Drug: roflumilast (EU: Daxas, USA: Daliresp)
Acute intervention: 1 time each dose on different days. Capsulated
Drug: roflumilast
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
Other Names:
  • Daxas
  • Daliresp
  • PDE4-inhibitor
Placebo Comparator: placebo Drug: Placebo
Acute intervention: single administration, capsulated form.
Drug: roflumilast
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
Other Names:
  • Daxas
  • Daliresp
  • PDE4-inhibitor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433666


Locations
Netherlands
Maastricht University, Faculty of Psychology and Neuroscience
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Jos H. Prickaerts, PhD Maastricht University
  More Information

Responsible Party: Marlies van Duinen, PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01433666     History of Changes
Other Study ID Numbers: METC11-3-035
ZonMw (the Netherlands) ( Other Grant/Funding Number: 95110091 )
2011-002070-23 ( EudraCT Number )
First Submitted: June 27, 2011
First Posted: September 14, 2011
Last Update Posted: September 4, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders