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EEGrofl: Roflumilast and Cognition

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01433666
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
22
Enrollment
1
Location
4
Arms
24
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Sep 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of words remembered on Verbal learning task [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01433666
    Other Study ID Numbers:
    • METC11-3-035
    • ZonMw (the Netherlands)
    • 2011-002070-23
    First Posted:
    Sep 14, 2011
    Last Update Posted:
    Jan 2, 2020
    Last Verified:
    Sep 1, 2013
    Additional relevant MeSH terms:
    Dementia
    Phosphodiesterase 4 Inhibitors

    Study Results

    No Results Posted as of Jan 2, 2020