Roflumilast and Cognition (EEGrofl)

This study has been completed.
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: September 3, 2013
Last verified: September 2013
  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:


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.


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: September 3, 2013
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 July 31, 2014