Roflumilast and Cognition

Sponsor
Maastricht University Medical Center
Study ID
NCT01433666
Phase
PHASE2
Status
Completed

Conditions

  • Dementia

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • roflumilast (EU: Daxas, USA: Daliresp) — DRUG
    Acute intervention: 1 time each dose on different days. Capsulated
  • Placebo — DRUG
    Acute intervention: single administration, capsulated form.
  • roflumilast — DRUG
    Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.

Study Details

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.

Key Dates

Start date
Sep 30, 2011
Status verified
Sep 2013
Primary completion
Jul 31, 2012
Completion
Sep 30, 2013

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: roflumilast 100ug
  • Experimental: roflumilast 300ug
  • Experimental: roflumilast1000ug
  • Placebo Comparator: placebo

Primary Outcome Measure

Number of words remembered on Verbal learning task [ Time Frame: 1hr after drug intake ]

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