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Roflumilast and Cognition (EEGrofl)

This study is currently recruiting participants.
Verified November 2011 by Maastricht University Medical Center
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Marlies van Duinen, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01433666
First received: June 27, 2011
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Dementia
Drug Information available for: Roflumilast
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Number of words remembered on Verbal learning task [ Time Frame: 1hr after drug intake ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 22
Study Start Date: September 2011
Estimated 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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433666

Contacts
Contact: Marlies A. van Duinen, PhD 0031-43-3881030 marlies.vanduinen@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University, Faculty of Psychology and Neuroscience Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Marlies A. van Duinen, PhD     0031-43-3881030     marlies.vanduinen@maastrichtuniversity.nl    
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

No publications provided

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), 2011-002070-23
Study First Received: June 27, 2011
Last Updated: November 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
 Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013