ClinicalTrials.gov
ClinicalTrials.gov Menu

Roflumilast and Cognition (EEGrofl)

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.
ClinicalTrials.gov Identifier: NCT01433666
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 4, 2013
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Marlies van Duinen, Maastricht University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Dementia Drug: roflumilast (EU: Daxas, USA: Daliresp) Drug: Placebo Drug: roflumilast Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arm Intervention/treatment
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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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 Posted: September 14, 2011    Key Record Dates
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