Roflumilast and Cognition

Phase 2

Completed

• Conditions: Dementia
• Interventions: Drug: Placebo; Drug: roflumilast

• Registration Number: NCT01433666
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-27
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Primary Completion: 2012-07
• Status Verified: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
roflumilast 300ug	roflumilast	-
roflumilast 100ug	roflumilast	-
placebo	roflumilast	-
roflumilast1000ug	roflumilast	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Maastricht University, Faculty of Psychology and Neuroscience; 🇳🇱 Maastricht, Limburg, Netherlands